IKT Inhibikase Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
IkT-148009
Parkinson’s disease
|
Phase 1b
Phase 1b
|
Phase 1b first patient dosed October 19, 2021. Phase 2a study to be initiated 2022.
|
Latest News
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BOSTON and ATLANTA, Nov. 15, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today reported financial results for the third quarter ended September 30, 2021 and highlighted recent developments.
Key Business and Clinical Highlights
- Dosed first patient in the Phase 1b clinical trial of IkT-148009: In October 2021 Inhibikase dosed the first patient in its Phase 1b clinical trial of IkT-148009, a randomized, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of IkT-148009. The trial will enroll a total of 24 patients with Parkinson's disease and also assess non-motor and motor function, gut motility, and measures of alpha-synuclein aggregate clearance, as exploratory endpoints. The Company expects to complete this study and, with the approval of the U.S. Food and Drug Administration (FDA), advance into a Phase 2a study in 2022.
- Extended Phase 1 clinical trial of IkT-148009 to higher doses: In October 2021, Inhibikase expanded dosing of IkT-148009 in older and elderly healthy volunteers up to a single 250 mg dose to identify the maximum tolerated dose. This extension was based on the safety and tolerability profile observed in the initial dose cohorts of the Phase 1 study.
- Submitted interim three-month results from chronic toxicology studies of IkT-148009 to FDA: In October 2021, Inhibikase reported that it had submitted interim three-month results from its ongoing chronic toxicology studies of IkT-148009 in rats and non-human primates to the FDA. Data indicated that the toxicology profile of IkT-148009 improves with extended daily oral dosing and supports evaluation in Parkinson's patients for up to three months.
- Received grant from U.S. National Institutes of Health to evaluate IkT-148009 for the treatment of Multiple System Atrophy: In September 2021, Inhibikase was awarded a research grant from the U.S. National Institute of Neurological Disease and Stroke (NINDS), an Institute of the National Institutes of Health (NIH), to evaluate the mechanism of the MSA disease process and the therapeutic potential of IkT-148009 in preclinical studies.
"Over the past quarter, we have worked diligently to advance our lead candidate, IkT-148009 in multiple indications. We dosed the first Parkinson's patient in our Phase 1b study as well as submitted interim chronic toxicology data to the FDA to support extended dosing of IkT-148009. We were also pleased to receive a grant from the NIH to evaluate IkT-148009 in a novel preclinical model of MSA, a neurodegenerative disease that may benefit from c-Abl inhibition," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we look ahead, we expect to file our IND application for IkT-001Pro for the treatment of CML in the first quarter of 2022 as well as anticipate completing our Phase 1b study for Ikt-148009 in 2022."
Third Quarter Financial Results
Net Loss: Net loss for the quarter ended September 30, 2021, was $4.5 million, or $0.18 per share, compared to a net loss of $0.7 million, or $0.08 per share in the third quarter 2020.
R&D Expenses: Research and development expenses were $3.2 million for the quarter ended September 30, 2021 compared to $.1 million in the third quarter 2020. The increase was driven by a $0.3 million increase in grant related research expenditures and a $2.8 million increase in non-grant related research. The non-grant related research was expended primarily in connection with the Company's Phase I Parkinson's disease clinical trial.
SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2021 were $1.6 million compared to $0.6 million for the third quarter in 2020. The increase was the result of increased non-cash stock compensation expense of $0.1 million, increased director and officer's liability insurance of $0.4 million related to the Company's IPO in December 2020, increased legal fees, board fees, investor relation and consulting fees of $0.3 million relating to operating as a public company registrant since December 2020 and a net increase of $0.2 million for other normal operating expenses.
Cash Position: Cash and cash equivalents were $45 million as of September 30, 2021.
About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Inhibikase has completed its planned Phase 1 studies evaluating the safety, tolerability and pharmacokinetics of IkT-148009 in older and healthy subjects and has commenced a Phase 1b study in Parkinson's patients. The company has further extended the Phase 1 older and elderly healthy volunteer study to explore the maximum tolerated dose further given the favorable adverse event profile seen to date. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMP™ medicinal chemistry program has identified a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.Social Media Disclaimer
Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use Twitter, Facebook, LinkedIn and YouTube as a means of disclosing information about the company, its services and other matters and for complying with its disclosure obligations under Regulation FD.Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Inhibikase's filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption "Risk Factors." Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.# # #
Inhibikase Therapeutics, Inc.
Condensed Balance Sheets
September 30,
2021December 31,
2020(unaudited)
Assets
Current assets:
Cash
$
44,845,950
$
13,953,513
Grants receivable
217,482
—
Prepaid research and development
264,381
774,356
Prepaid expenses and other current assets
541,388
54,837
Total assets
$
45,869,201
$
14,782,706
Liabilities and stockholders' equity
Current liabilities:
Accounts payable
$
553,801
$
1,720,680
Accrued expenses and other current liabilities
1,905,010
632,934
Deferred revenue
—
2,325,741
Notes payable
248,911
42,534
Total
2,707,722
4,721,889
Notes payable, net of current portion
—
276,461
Total liabilities
2,707,722
4,998,350
Commitments and contingencies (see Note 11)
Stockholders' equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2021 and December 31, 2020; 0 shares issued and outstanding at September 30, 2021 and December 31, 2020
—
—
Common stock, $0.001 par value; 100,000,000 and 30,000,000 shares authorized; 25,155,198 and 10,050,849 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively.
25,155
10,051
Additional paid-in capital
67,912,392
24,805,929
Accumulated deficit
(24,776,068)
(15,031,624)
Total
43,161,479
9,784,356
Total liabilities and stockholders' equity
$
45,869,201
$
14,782,706
Inhibikase Therapeutics, Inc.
Condensed Statements of Operations
(Unaudited)
Three Months Ended
September 30,Nine Months Ended
September 30,2021
2020
2021
2020
Revenue:
Grant revenue
$
328,459
$
37,680
$
3,098,661
$
528,052
Total revenue
328,459
37,680
3,098,661
528,052
Costs and expenses:
Research and development
3,154,553
120,569
7,968,846
666,858
Selling, general and administrative
1,644,946
580,820
4,854,494
1,478,839
Total costs and expenses
4,799,499
701,389
12,823,340
2,145,697
Loss from operations
(4,471,040)
(663,709)
(9,724,679)
(1,617,645)
Interest expense
(157)
(6,890)
(19,765)
(22,263)
Net loss
$
(4,471,197)
$
(670,599)
$
(9,744,444)
$
(1,639,908)
Net loss per share – basic and diluted
$
(0.18)
$
(0.08)
$
(0.61)
$
(0.20)
Weighted-average number of common shares – basic and diluted
25,143,559
8,198,754
15,868,421
8,187,517
View original content to download multimedia:https://www.prnewswire.com/news-releases/inhibikase-therapeutics-reports-third-quarter-2021-financial-results-and-highlights-recent-period-activity-301424662.htmlSOURCE Inhibikase Therapeutics, Inc.
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ATLANTA and BOSTON, Oct. 27, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced that Dr. Milton Werner, Ph.D., President & Chief Executive Officer of Inhibikase, will participate in the Michael J. Fox Foundation Alpha-Synuclein Summit being held virtually from November 3-4, 2021.
Dr. Werner will detail the pivotal role of c-Abl in driving neurodegeneration and neuroinflammation in Parkinson's disease (PD) as well as provide a comprehensive biochemical overview of the early stages of the disease process. During the presentation, Dr. Werner will also highlight data from pre-clinical and clinical studies of IkT-148009, which further validate the role of c-Abl in the progression of PD and support the continued clinical development of IkT-148009 as a novel treatment option. After the presentation, Dr. Werner will participate on an expert panel to discuss the various strategies now being pursued in the clinic to modulate pathological alpha-synuclein in patients.
Michael J. Fox Foundation Alpha-Synuclein Summit:
Presentation: Functional recovery and clearance of alpha-synuclein toxicity following therapeutic administration of the oral c-Abl inhibitor IkT-148009
Date: Wednesday, November 3, 2021
Time: 12:25pm ETPanel Discussion
Date: Wednesday, November 3, 2021
Time: 12:35pm ETAbout Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Inhibikase has completed its Phase 1 studies evaluating the safety, tolerability and pharmacokinetics of IkT-148009 in older and healthy subjects and has commenced a Phase 1b study in Parkinson's patients. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMP™ medicinal chemistry program has identified a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.Social Media Disclaimer
Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use Twitter, Facebook, LinkedIn and YouTube as a means of disclosing information about the company, its services and other matters and for complying with its disclosure obligations under Regulation FD.Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Inhibikase's filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption "Risk Factors." Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
View original content to download multimedia:https://www.prnewswire.com/news-releases/inhibikase-therapeutics-to-participate-in-upcoming-michael-j-fox-foundation-alpha-synuclein-summit-301407327.htmlSOURCE Inhibikase Therapeutics, Inc.
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ATLANTA, Oct. 19, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced dosing of the first Parkinson's patient in its Phase 1b clinical trial of IkT-148009, an Abelson Tyrosine Kinase, or c-Abl, inhibitor for the treatment of Parkinson's disease.
The Phase 1b extension study is a 3:1 randomized, placebo-controlled trial investigating the safety, tolerability and pharmacokinetics of IkT-148009. The trial will enroll a total of 24 patients with Parkinson's disease across 3 escalating doses (8 patients per cohort). The study will also assess cognitive, motor function, gut motility and measures of alpha-synuclein aggregate clearance in multiple compartments, as exploratory endpoints. The Company previously reported results from its Phase 1 study of IkT-148009 in older and elderly healthy volunteers, which achieved high drug exposure between 12.5 and 100 mg with no clinically significant adverse events across 56 patients. These results were consistent with exposures observed in animal efficacy studies of inherited and sporadic progressive Parkinson's disease.
"We are pleased to begin dosing patients in our Phase 1b study. This is the first time we will assess our selective c-Abl kinase inhibitor in Parkinson's patients, which could give us an early look into the potential efficacy of this treatment in slowing or possibly halting disease progression and even partly restoring functional loss in Parkinson's disease," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. "As we look ahead, we anticipate completing this study and advancing into a Phase 2a study in 2022."
c-Abl is a clinically validated target that is activated once plaques of alpha-synuclein are internalized by the affected neurons in the brain and gut. C-Abl drives biochemical pathways and processes that lead to degradation of the neurons affected in Parkinson's disease. Inhibition of c-Abl may restore functional loss for neurons that have not fully degraded in the brain and remodel neurons in the gastrointestinal tract, two major organ systems affected by the disease.
About IkT-148009
IkT-148009 is a selective c-Abl kinase inhibitor that uniquely inhibits c-Abl and the closely related Abl2/Arg enzyme without inhibition of other members of the Abl-kinase family, namely c-Kit or PDGFRa/b. It has nearly 20x the potency of the anticancer agent Imatinib against c-Abl in enzyme inhibition assays. The extension of the Company's Phase 1 study into the patient population, a Phase 1b, will focus on safety, tolerability and pharmacokinetics measured over 7 to 14 days. The Company reported interim 13-week toxicology study outcomes to the FDA in October, 2021. Following Agency review and agreement, the Company plans to dose patients out to 3 months. Cognitive, motor function and gut motility tests will all be assessed as exploratory endpoints in this Phase 1b study, to include measures of alpha-synuclein aggregate clearance in multiple compartments as a consequence of treatment.About Parkinson's Disease
Parkinson's disease (PD) is the second most prevalent neurodegenerative disorder, affecting approximately 1,000,000 persons in the United States, with 60,000 new cases and 38,000 deaths annually. PD is a progressive neurodegenerative disease that initiates with misfolding of a small, non-essential protein known as alpha-synuclein inside and outside of the brain. The common features of PD include tremors at a resting state, slowing or lack of control of movement and postural instability. These features of the disease arise from degeneration of neurons that secrete dopamine to transmit neurological signals. The degeneration of these dopaminergic neurons in nigrostriatal area of the brain near the brainstem, coupled with the accumulation of alpha-synuclein protein aggregates in cell bodies and terminals known as Lewy bodies, have long been thought to be the cause of the disease. Less well known are the features of this disease can affect serotonin levels, cholinergic, and norepinephrine neurons and nerve cells in the olfactory system, cerebral hemisphere, brain stem, spinal cord, and peripheral autonomic nervous system such as in the GI tract. Currently, these non-dopaminergic features are not properly controlled with dopamine-replacement or levodopa therapy.About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Inhibikase has completed its Phase 1 studies evaluating the safety, tolerability and pharmacokinetics of IkT-148009 in older and healthy subjects and has commenced a Phase 1b study in Parkinson's patients. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMP™ medicinal chemistry program has identified a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.Social Media Disclaimer
Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use Twitter, Facebook, LinkedIn and YouTube as a means of disclosing information about the company, its services and other matters and for complying with its disclosure obligations under Regulation FD.Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Inhibikase's filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption "Risk Factors." Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
View original content to download multimedia:https://www.prnewswire.com/news-releases/inhibikase-therapeutics-announces-dosing-of-first-parkinsons-patient-in-its-phase-1b-clinical-trial-of-ikt-148009-301402749.htmlSOURCE Inhibikase Therapeutics, Inc.
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ATLANTA, Oct. 4, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced interim three-month results from its ongoing chronic toxicology studies of oral IkT-148009 administered in rats and non-human primates (NHPs).
The Company's ongoing toxicology studies of IkT-148009 are designed to meet the regulatory requirements for chronic dosing in humans, which include daily oral administration in rats for six months and in NHPs for nine months. In addition to these requirements, Inhibikase has added three-month dosing cohorts in rats and NHPs to support evaluation in Parkinson's patients for up to three months in its planned Phase 2a study. Today's update includes interim results at three months from both animal species, across which the toxicology profile for IkT-148009 improved the longer the drug was dosed.
"As a highly selective kinase inhibitor, IkT-148009 has demonstrated it is distinct in its ability to discriminate against the target enzyme, c-Abl, without engaging other targets in the Abelson enzyme family, including c-KIT and PDGFRa-b. We believe this property may enable IkT-148009 to offer best-in-class safety, avoiding the most harmful side-effects commonly associated with c-Abl inhibitors the longer they are dosed in patients," stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. "We are pleased to share interim data from ongoing chronic toxicology studies that support this hypothesis, indicating a more favorable profile in rats and non-human primates given extended treatment with IkT-148009. These learnings, coupled with the absence of clinically significant adverse events in our Phase 1 study, add to our growing confidence in the safety and tolerability of IkT-148009. Taken together with efficacy signals observed preclinically, we look forward to evaluating IkT-148009 in a planned Phase 2a study, subject to FDA agreements, to see how this profile translates into patients with Parkinson's disease."
Inhibikase previously submitted 14-day toxicology data in rats and NHPs to the U.S. Food and Drug Administration (FDA) prior to initiating the Company's Phase 1 trial of IkT-148009 in older healthy subjects. In the 14-day study, the No Adverse Event Level (NOAEL), a measure of drug safety in animals, was determined to be 31.2 mg in NHPs, but could not be determined in rats. Following three months of dosing, NOAEL measurements in rats and NHPs were 50 mg and 75 mg, respectively, representing a 2.4-fold increase in NHPs and establishing a standard for rats.
Following FDA review of these three-month toxicology results, and subject to agreement with the Agency, the Company plans to initiate a Phase 2a study in 2022 to evaluate daily oral administration of IkT-148009 in up to 120 Parkinson's patients out to three months.
About IkT-148009
IkT-148009 is a selective c-Abl kinase inhibitor that uniquely inhibits c-Abl and the closely related Abl2/Arg enzyme without inhibition of other members of the Abl-kinase family, namely c-Kit or PDGFRa/b. It has nearly 20x the potency of the anticancer agent Imatinib against c-Abl in enzyme inhibition assays. The extension of the Company's Phase 1 study into the patient population, a Phase 1b, will focus on safety, tolerability and pharmacokinetics measured over 7 to 14 days. Following Agency review of 13-week pivotal toxicology data discussed herein and depending on agreement with the U.S. FDA on the clinical path going forward, the Company plans to initiate a Phase 2a study and dose up to 120 patients for up to 3 months of daily dosing at three different doses. Cognitive, motor function and gut motility tests will all be assessed as exploratory endpoints in these Phase 1b and Phase 2a studies, to include measures of alpha-synuclein aggregate clearance in multiple tissues and/or fluids as a consequence of treatment.About Parkinson's Disease
Parkinson's disease (PD) is the second most prevalent neurodegenerative disorder, affecting approximately 1,000,000 persons in the United States, with 60,000 new cases and 38,000 deaths annually. PD is a progressive neurodegenerative disease that initiates with misfolding of a small, non-essential protein known as alpha-synuclein inside and outside of the brain. The common features of PD include tremors at a resting state, slowing or lack of control of movement and postural instability. These features of the disease arise from degeneration of neurons that secrete dopamine to transmit neurological signals. The degeneration of these dopaminergic neurons in nigrostriatal area of the brain near the brainstem, coupled with the accumulation of alpha-synuclein protein aggregates in cell bodies and terminals known as Lewy bodies, have long been thought to be the cause of the disease. Less well known are the features of this disease can affect serotonin levels, cholinergic, and norepinephrine neurons and nerve cells in the olfactory system, cerebral hemisphere, brain stem, spinal cord, and peripheral autonomic nervous system such as in the GI tract. Currently, these non-dopaminergic features are not properly controlled with dopamine-replacement or levodopa therapy.About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Inhibikase is currently evaluating the safety, tolerability and pharmacokinetics of IkT-148009 in older and elderly healthy subjects and Parkinson's patients. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMPTM medicinal chemistry program has identified a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.Social Media Disclaimer
Investors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The company intends to also use Twitter, Facebook, LinkedIn and YouTube as a means of disclosing information about the company, its services and other matters and for complying with its disclosure obligations under Regulation FD.Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Inhibikase's filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption "Risk Factors." Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
View original content to download multimedia:https://www.prnewswire.com/news-releases/inhibikase-therapeutics-announces-interim-three-month-results-from-chronic-toxicology-studies-of-its-oral-c-abl-kinase-inhibitor-ikt-148009-in-development-for-treatment-of-parkinsons-disease-301391388.htmlSOURCE Inhibikase Therapeutics, Inc.
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ATLANTA, Sept. 23, 2021 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (NASDAQ:IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced that the Company has been awarded a $385,388 research grant from the U.S. National Institute of Neurological Disease and Stroke (NINDS), an Institute of the National Institutes of Health (NIH), to evaluate the therapeutic potential of IkT-148009, the Company's lead c-Abl inhibitor, in a novel preclinical model for Multiple System Atrophy (MSA).
MSA is a rare, rapidly progressive neurodegenerative movement disorder affecting both the central and autonomic nervous systems. MSA is characterized by pathological alpha-synuclein aggregation, which may lead to oligodendroglial cell dysfunction and degeneration of neurons. Symptoms of MSA reflect this progressive degeneration and manifest as failures in the autonomic nervous system (i.e. digestion, blood flow and pressure, etc.), Parkinsonism cerebellar ataxia, and pyramidal signs. There are currently no approved therapies to slow or halt the progression of MSA and there is no cure.
In work conducted in collaboration with the Laboratory of Jeffrey Kordower Ph.D., founding director of the Arizona State University Banner Neurodegenerative Disease Research Center, it was established that pathological alpha-synuclein in oligodendroglial cells contains the same hallmarks of c-Abl activation as in Parkinson's disease. Namely, the phosphorylation at a specific tyrosine residue in the pathological alpha-synuclein aggregates1. This grant will allow Inhibikase to evaluate the mechanism of the MSA disease process in a novel rodent model to determine if IkT-148009 could have the same therapeutic impact on the disease process as it has in models of Parkinson's disease. A complementary effort is underway in a second rodent model of MSA in collaboration with Erwan Bezard, Ph.D., INSERM Research Director, Institute of Neurodegenerative Diseases at the University of Bordeaux and non-executive director of Motac Neuroscience.
"MSA affects approximately 20,000 people in the U.S. with no meaningful therapies approved to slow or halt the progression of disease," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. "This grant will help us to model and understand the mechanisms that drive MSA and we are pleased to be recognized by our scientific peers at NINDS and NIH. Simultaneously, we will work in collaboration with leading experts in the field to establish the regulatory framework to advance IkT-148009 into clinical development for MSA. We believe that the continued support from government and non-profit organizations serve to further validate the potential of our science and we look forward to advancing our pipeline to treat neurodegenerative disorders."
About IkT-148009
IkT-148009 is a selective c-Abl kinase inhibitor that uniquely inhibits c-Abl and the closely related Abl2/Arg enzyme without inhibition of other members of the Abl-kinase family, namely c-Kit or PDGFRa/b. It has nearly 20x the potency of the anticancer agent Imatinib against c-Abl in enzyme inhibition assays. Clinical development of IkT-148009 advanced into Parkinson's patients just 5 months into the clinical development program with excellent pre-clinical and clinical safety profiles and no clinically significant adverse events observed to date. The first patient to be dosed with IkT-148009 is anticipated to occur early in the fourth quarter of 2021.________________________
1 (Neurobiology of Disease v. 148, page 105184 (2021). doi: 10.1016/j.nbd.2020.105184).
About Multiple System Atrophy
Multiple system atrophy (MSA) is a neurodegenerative movement disorder affecting approximately 20,000 people in the US. It occurs sporadically, usually presenting between the age 35 and 65 with a variable combination of parkinsonian, cerebellar, and autonomic features that rapidly progress to dangerous morbidity. Research toward potential treatments for MSA has been limited, resulting in a paucity of knowledge regarding its underlying causes, and there are no currently approved treatments to halt pathological progression. Initial evidence to the origins of MSA were generated by studying alpha-synuclein and its hallmark histopathology in the brains of patients with MSA. These studies established that MSA is characterized by the presence of glial cytoplasmic inclusions (GCIs) that reside predominantly in oligodendroglial cells. GCIs are comprised of abnormal conformations of alpha-synucelin, the same protein that accumulates in neurons and Lewy Bodies in Parkinson's disease (PD) and Lewy Body Dementia (LBD). Some phenotypes of MSA have little or no clinically pertinent parkinsonism, and instead present with cerebellar ataxia or dysautonomia, most frequently as orthostatic hypotension. As a reflection of the variable clinical spectrum, there is highly variable oligodendrocyte degeneration seen in the basal ganglia (substantia nigra, cardate, putamen), the cerebellum (cerebellar cortex, and Purkinje cells), and the autonomic nuclei (locus caeruleus, dorsal motor nucleus of the vagus, intermediolateral cell column of the spinal cord). Alpha-synuclein inclusions from MSA are capable of propagating to adjacent cells and inducing neurodegeneration when injected into transgenic mice, suggesting that MSA may be a prion disease. Additionally, alpha-synuclein in oligodendrocytes induces deficits in myelination in contrast to what is seen for synuclein aggregates in PD.About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (NASDAQ:IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain. Inhibikase has completed its Phase 1 studies evaluating the safety, tolerability, and pharmacokinetics of IkT-148009 in older and healthy subjects and has commenced a Phase 1b study in Parkinson's patients. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent Imatinib that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMPTM medicinal chemistry program has identified a number of follow-on compounds to IkT-148009 to be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.Social Media Disclaimer
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