HEPA Hepion Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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CRV431
Non-alcoholic steatohepatitis
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Phase 2a
Phase 2a
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Valnivudine - FV-100
Shingles
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Phase 3
Phase 3
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Phase 3 trial discontinued - November 2017.
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Latest News
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- Positive CRV431 Data in Models of Acute Pulmonary Injury and SARS-CoV-2 Viral Replication -
- CRV431 attenuated lung inflammation and damage similar to or better than dexamethasone, including reductions in neutrophils and IL-6
- CRV431 decreased SARS-CoV-2 replication and production of infectious virus in vitro
- CRV431 may offer opportunity to treat both viral infection and lung inflammation in COVID-19
EDISON, NJ / ACCESSWIRE / July 7, 2020 / Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA)("Hepion"), a biopharmaceutical company focusing on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced that its clinical phase, anti-fibrotic drug candidate, CRV431, additionally was efficacious in two distinct preclinical research models related to COVID-19 disease. Firstly, CRV431 demonstrated strong anti-inflammatory actions in a non-viral, acute lung injury model and on some measures outperformed dexamethasone, a recently recommended treatment for COVID-19. Secondly, cell culture experiments demonstrated CRV431 antiviral activity towards SARS-CoV-2, the virus responsible for COVID-19 disease. These results indicate the potential of CRV431 to simultaneously address the two most important objectives in the development of a therapeutic drug for COVID-19.
Many individuals infected with SARS-CoV-2 coronavirus develop respiratory symptoms which can progress to a severe form of lung disease called acute respiratory distress syndrome ("ARDS"). ARDS patients may require admission to intensive care units and are at increased risk of death. COVID-19-associated ARDS is characterized by lung cell damage, white blood cell inflammation, especially neutrophils, and elevated levels of inflammatory molecules such as interleukin-6 ("IL-6").1 One strategy to treat COVID-19 patients is to try to decrease the viral infection with antiviral therapies. Another strategy is to try to dampen the inflammatory responses that lead to ARDS and other COVID-19 complications. The antiviral drug, remdesivir, and the anti-inflammatory corticosteroid, dexamethasone, have emerged as front-line treatments for severely affected COVID-19 patients.2 However, concerns also have been expressed about the utility of these treatments, such as their potency and the possibility that corticosteroid treatment could increase peak viral titers.
Acute Lung Injury Testing
To evaluate CRV431 anti-inflammatory properties in acute lung injury, a study was performed by Biomodels LLC in which mice were intranasally administered the microbial toxin, lipopolysaccharide ("LPS"), to induce severe lung inflammation similar to ARDS. Some mice additionally received CRV431, drug vehicle, or dexamethasone. A fourth group of mice were intranasally administered saline instead of LPS, representing the non-diseased group. Lung inflammation was assessed two days after LPS administration by quantifying inflammatory cells and cytokines in bronchial alveolar lavage ("BAL") fluid.
LPS administration caused extensive lung inflammation characterized by a 10-fold increase in white blood cells of which 80% were neutrophils and 18% were macrophages. CRV431 decreased total inflammatory cell counts by 62% and neutrophil counts by 66%. In comparison, dexamethasone decreased total cell and neutrophil counts by only 3% and 8%, respectively. LPS also caused increases in the concentrations of inflammatory cytokines in the BAL fluid: IL-1β (18-fold increase), TNFα (156-fold increase), and most significantly, IL-6 (1,943-fold increase). CRV431 decreased the concentrations of all three cytokines in LPS mice by 62 - 69%, and dexamethasone decreased all three cytokines by 69 - 91%. Lastly, lung damage was evident by a 2.3-fold increase in total protein in BAL fluid, and both CRV431 and dexamethasone attenuated the increase in protein by 70% and 76%, respectively. In summary, CRV431 demonstrated broad-spectrum, anti-inflammatory properties that were similar, or in the case of neutrophil infiltration, superior to dexamethasone.
"The treatment response to CRV431 was one of the best that we have seen to-date, matching or exceeding the efficacy of the steroid dexamethasone," commented Dr. Gregory Lyng, Chief Operating Officer, Biomodels LLC. "These are very promising results and our entire team is excited to see how this compound progresses as a potential therapeutic for COVID-19-related pulmonary dysfunction. Biomodels has extensively used a model of LPS-induced acute lung injury/acute respiratory distress syndrome to evaluate the efficacy of many of our customers' promising drug candidates as potential treatments for CODID-19-related pulmonary dysfunction. Prophylactic treatment with CRV431 in this model resulted in substantial and statistically significant reductions in lung inflammation, as measured by assessment of cellular infiltrate and key inflammatory cytokines in the lung bronchoalveolar lavage fluid."
SARS-CoV-2 Antiviral Testing
In vitro antiviral activity of CRV431 toward SARS-CoV-2 was demonstrated by Dr. Tom Hobman, Professor and Member of the Li Ka Shing Institute of Virology at University of Alberta. SARS-CoV-2 replication was assessed in three cell lines by measurement of viral RNA and secretion of infectious virus from the cells. CRV431 decreased one or both markers of SARS-CoV-2 in all cell types and in all experiments. The extent of SARS-CoV-2 reduction was dependent on CRV431 concentration, cell type, and type of measurement but in some experiments exceeded 90%.
Dr. Daren Ure, Hepion's Chief Scientific Officer, stated, "Antiviral activity in these cell lines was relatively modest, but the experiments demonstrated that CRV431 definitely has the capacity to attenuate SARS-CoV-2. Further testing is warranted in more robust experimental systems to evaluate the magnitude of CRV431's effects. Dr. Hobman's results are consistent with many studies on SARS-CoV-2 and the closely related SARS virus that indicate that blocking the binding of these viruses to cellular cyclophilin molecules, the molecular target of CRV431, is a novel and potentially effective antiviral strategy. In our view, it is biologically incredible and fortuitous that inhibition of cyclophilins can simultaneously reduce antiviral activity and decrease acute lung injury. These activities are in addition to CRV431's antifibrotic properties which have been observed in many preclinical models, including explanted human lung tissue, and which also is proposed to be beneficial for COVID-19 patients with severe lung disease.3,4 To our knowledge, no other drug candidate has such a range of activities that are relevant to treating patients infected with SARS-CoV-2."
Dr. Robert Foster, Hepion's Chief Executive Officer added, "While NASH remains the primary indication for CRV431, we will be working with our team to evaluate advancing CRV431 in pulmonary disease, given the critical needs for effective treatment of pulmonary diseases, including ARDS, and COVID-19. Although there is evidence in the literature that supports the benefits of cyclophilin inhibition, we have been reluctant to connect CRV431 with COVID-19 and acute lung injury until we had generated compelling data, which we now have. Our preclinical studies, conducted by well-respected third parties, offer insights into the potential benefits to COVID-19 patients by using a novel two-pronged strategy, not only to reduce viral load, but to deal with lung damage that may occur in COVID-19 patients. We will endeavor to pull together the necessary resources and/or seek collaborations to create an opportunity for CRV431 in COVID-19, while maintaining our focus on advancing CRV431 for NASH in the clinic."
References
1 https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30243-5/fulltext; https://www.frontiersin.org/articles/10.3389/fmed.2020.00301/full; https://www.degruyter.com/view/journals/cclm/58/7/article-p1021.xml
2 https://www.covid19treatmentguidelines.nih.gov/
3 http://irdirect.net/prviewer/release/id/4259058
4 https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30222-8/fulltext
About Hepion Pharmaceuticals
Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and other types of hepatitis. The Company's lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431's potent inhibition of cyclophilins, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]hepionpharma.comSOURCE: Hepion Pharmaceuticals, Inc.
View source version on accesswire.com:
https://www.accesswire.com/596510/Hepion-Pharmaceuticals-Announces-Preclinical-Data-Supporting-Novel-Two-Pronged-Approach-to-Treating-COVID-19-with-CRV431
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EDISON, NJ / ACCESSWIRE / June 29, 2020 / Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced the advancement to the final dose level in its ongoing clinical trial of CRV431, a Phase 1b multiple ascending dose ("MAD") study.
The open-label MAD study is designed to assess safety, tolerability and pharmacokinetics of CRV431, administered orally to healthy volunteers, once daily for 28 days. To date, the study has examined doses of 75 mg, 150 mg, 225 mg and 300 mg.
The Clinical Trial Management team has reviewed the 300 mg cohort data and determined this dosing level to be safe and well tolerated, authorizing advancement to the final dosing level of 375 mg daily for 28 days.
"We initially planned to proceed only to the 300 mg dosing level, as we believe the dose required to demonstrate efficacy in future NASH trials will not exceed 300 mg," said Dr. Patrick Mayo, Hepion's Senior Vice-President, Clinical Pharmacology. "However, we have not yet observed any dose-limiting side effects, even at 300 mg. As such, we decided to add one final dosing cohort of 375 mg to fully evaluate safety and tolerability, and pharmacokinetics of CRV431. This study has demonstrated that steady-state CRV431 concentrations achieved at a 75 mg daily dose are in the range that demonstrates efficacy in animal models and human liver tissue. This suggests that the dosing range captured in this study effectively explored clinically relevant exposures."
Dr. Stephen Harrison, Hepion's Consultant Medical Director added, "We are exceedingly pleased that CRV431 continues to be very well tolerated throughout the entire Phase 1 program, which well positions Hepion for our upcoming Phase 2a clinical trial in NASH patients."
About Hepion Pharmaceuticals
Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and other types of hepatitis. The Company's lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431's potent inhibition of cyclophilins, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]SOURCE: Hepion Pharmaceuticals, Inc.
View source version on accesswire.com:
https://www.accesswire.com/595624/Hepion-Pharmaceuticals-Announces-Advancement-to-Final-Dose-Level-in-Ongoing-Multiple-Ascending-Dose-Clinical-Study-of-CRV431
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Results Support CRV431's Potential to More Broadly Treat Fibrotic Diseases
EDISON, NJ / ACCESSWIRE / June 22, 2020 / Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) ("Hepion" or the "Company"), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced results from a study of the Company's lead drug candidate, CRV431, demonstrating antifibrotic activity in an experimental model of renal fibrosis.
The study, which was conducted by SMC Laboratories in Tokyo, Japan, evaluated CRV431 in the Unilateral Ureteral Obstruction ("UUO") mouse model. Mice that underwent left ureter surgical ligation were orally administered either vehicle or CRV431 at a dose of 50 mg/kg/day for two weeks (n=8 mice/group). A third group of eight mice, the Sham group, did not undergo surgery and did not receive drug treatment. The fibrotic scarring in response to the UUO procedure was visualized by Sirius red staining of histological sections from the affected kidneys. Quantitation of the Sirius red staining at the end of the study demonstrated that kidney fibrosis was significantly elevated in vehicle treated UUO mice, compared to the Sham group. Kidney fibrosis in the CRV431 treated group was 42% lower as compared to vehicle treated mice (p=0.0006).
"CRV431 has exerted antifibrotic activity in a number of in vitro and in vivo studies conducted by independent research laboratories in the United States, United Kingdom, France, and Japan," stated Dr. Daren Ure, Hepion's Chief Scientific Officer. "These included five studies in the "STAM™" and "Western Diet" mouse models of NASH; two studies of liver fibrosis induced by liver toxins; and two separate ex vivo studies of explanted human liver and lung tissues. Notably, the explanted lung tissue study in which CRV431 was efficacious used lung tissue obtained from a patient with idiopathic pulmonary fibrosis. The latest findings in this kidney study further confirm that CRV431 decreases fibrotic scarring in multiple organs, regardless of etiology."
Dr. Robert Foster, Hepion's Chief Executive Officer, commented, "To date, every one of our preclinical studies has consistently demonstrated CRV431's antifibrotic activity. In addition to inhibiting cyclophilins, which play a critical role in the formation of collagen, CRV431 down-regulates gene expression and decreases production and secretion of proteins important to fibrosis. As such, we are advancing what we believe to be a direct-acting antifibrotic molecule in the clinic for the treatment of NASH, which represents a novel approach within the NASH landscape of investigational drugs."
About Hepion Pharmaceuticals
Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and other types of hepatitis. The Company's lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431's potent inhibition of cyclophilins, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third-party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]SOURCE: Hepion Pharmaceuticals, Inc.
View source version on accesswire.com:
https://www.accesswire.com/594780/Hepion-Pharmaceuticals-CRV431-Demonstrates-Efficacy-in-Kidney-Fibrosis
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EDISON, NJ / ACCESSWIRE / June 10, 2020 / Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced that Dr. Peter Wijngaard has joined its Board of Directors.
"Dr. Wijngaard provided invaluable guidance to Hepion's management team during our earlier work on cyclophilin inhibitors at Isotechnika Pharmaceuticals, Aurinia Pharmaceuticals, and Ciclofilin Pharmaceuticals, so we are thrilled to welcome him to our Board at this important point in Hepion's evolution," said Dr. Robert Foster, Hepion's CEO. "With an exceptional amount of experience in all aspects of drug development, we are delighted to have the benefit of Dr. Wijngaard's insights as we prepare to advance CRV431 to Phase 2 trials for NASH."
"I am excited to have this opportunity to work, once again, with Hepion's leadership team, particularly given my firsthand observation of their ability to effectively lead and execute all phases of drug development," Dr. Wijngaard said. "I am looking forward to contributing to the extensive experience this team has amassed over decades of working on cyclophilin inhibitors, and to supporting management as they work to realize CRV431's potential as a treatment for NASH and fibrosis."
Dr. Wijngaard most recently served as Executive Vice President, Chief Development Officer at The Medicines Company ("MDCO"), where he led the overall development and global medical affairs activities for hypercholesterolemia drug candidate, inclisiran. Dr. Wijngaard was instrumental in Novartis' US $9.7 billion acquisition of MDCO that was completed in January 2020.
During his 10 year career at MDCO, Dr. Wijngaard held roles of increasing responsibility, leading numerous drug development programs and gaining extensive experience in global project leadership; business development; medical affairs; pharmaceutical commercial strategy; and regulatory and chemistry, manufacturing and controls technical development.
Previously, Dr. Wijngaard led European Medical Affairs and Development at Viropharma Inc. (which was subsequently acquired by Shire Pharmaceuticals in 2013 and is now part of The Takeda Pharmaceutical Company Limited) and held various positions at Hoffmann-La Roche, including International Medical Manager and Lifecycle Leader for the transplantation portfolio, as well as managing the Genentech alliance as Global Alliance Director. He served on the Board of Directors of Isotechnika Pharmaceuticals, Aurinia Pharmaceuticals and Ciclofilin Pharmaceuticals, which was acquired by Hepion in 2016. As an author of more than 50 scientific articles, Dr. Wijngaard has published extensively on transplant immunology and immunosuppression. He has a Ph.D. in Transplantation Immunology from Utrecht University, the Netherlands.
About Hepion Pharmaceuticals
Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and other types of hepatitis. The Company's lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431's potent inhibition of cyclophilins, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]SOURCE: Hepion Pharmaceuticals, Inc.
View source version on accesswire.com:
https://www.accesswire.com/593459/Hepion-Pharmaceuticals-Welcomes-Industry-Veteran-and-Drug-Development-Expert-Dr-Peter-Wijngaard-to-its-Board-of-Directors
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EDISON, NJ / ACCESSWIRE / May 20, 2020 / Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced the advancement to the fourth dose level in its ongoing clinical trial of CRV431, a Phase 1b multiple ascending dose ("MAD") study.
The open-label MAD study is designed to assess safety, tolerability and pharmacokinetics of CRV431, administered orally to healthy volunteers, once daily for 28 days. To date, the study has examined doses of 75 mg, 150 mg, and 225 mg.
The Clinical Trial Management team has reviewed the 225 mg cohort data and determined this dosing level to be safe and well tolerated, authorizing advancement to the next dosing level of 300 mg daily for 28 days.
"This ongoing MAD study continues to demonstrate CRV431's safety and tolerability with no indications of any dose-limiting toxicities," said Dr. Patrick Mayo, Hepion's Senior Vice-President, Clinical Pharmacology. "An additional dose escalation beyond 300 mg may be warranted to fully characterize CRV431's safety and maximum tolerated dose, but we will make that determination once the 300 mg cohort has been completed."
Dr. Stephen Harrison, Hepion's Consultant Medical Director added, "The drug appears to be very well-tolerated with no meaningful treatment-associated adverse effects. The blood concentrations of CRV431 we have already achieved are above those likely required for efficacy, which bodes well for a potentially positive risk-benefit in NASH patients and is why we are so excited about commencing the Phase 2a study in NASH."
About Hepion Pharmaceuticals
Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and other types of hepatitis. The Company's lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431's potent inhibition of cyclophilins, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2019 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
[email protected]SOURCE: Hepion Pharmaceuticals, Inc.
View source version on accesswire.com:
https://www.accesswire.com/590738/Hepion-Pharmaceuticals-Announces-Advancement-to-Fourth-Dose-Level-in-Ongoing-Multiple-Ascending-Dose-Clinical-Study-of-CRV431