About Us | ScientistABIO ARCA biopharma Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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rNAPc2 (AB201) - (ASPEN)
COVID-19
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Phase 2b
Phase 2b
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Drug Pipeline
| Drug | Stage | Notes |
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Gencaro
Chronic Heart Failure
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Phase 3
Phase 3
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Phase 3 trial initiation on hold - dependent on obtaining additional financing.
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Latest News
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- Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for COVID-19 expanded to South America
- Topline data anticipated in the fourth quarter of 2021
WESTMINSTER, Colo., Aug. 04, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported second quarter 2021 financial results and provided a corporate update.
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "We continue to be encouraged with the opportunities we see in our development pipeline compounds, rNAPc2 and Gencaro. With the ASPEN-COVID-19 Phase 2b trial of rNAPc2 expanding to South America, we look forward to completing the trial and we anticipate sharing the results in the fourth quarter. Given the rate of global vaccination and the continued emergence of variants, along with rNAPc2's combination of anticoagulant, anti-inflammatory and antiviral properties, we believe it has the potential to be effective in addressing COVID-19 impacts in hospitalized patients. For Gencaro, we believe that, if approved, it may be a safe and effective therapy for the treatment of higher ejection fraction heart failure patients with atrial fibrillation and look forward to evaluating it in the planned PRECISION-AF Phase 3 clinical study."
Pipeline Update
rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.
- On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19.
- ASPEN-COVID-19 expanding to South America with regulatory clinical trial commencement authorizations in Argentina and Brazil.
- Phase 2b topline data anticipated in the fourth quarter of 2021.
- In July, the Company entered into a patent assignment agreement with the University Medical Center of Johannes Gutenberg University Mainz, Germany, under which ARCA received exclusive world-wide patent rights related to the use of rNAPc2 as a potential treatment for COVID-19, and other potential indications.
GencaroTM (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).
- Gencaro Phase 2b data on AF burden and rhythm control interventions was published in Circulation: Arrhythmia and Electrophysiology, a journal of the American Heart Association. In the Phase 2b superiority clinical trial, although the prespecified primary endpoint was not met, compared with metoprolol, Gencaro reduced AF burden, delayed AF progression, increased maintenance of sinus rhythm, and reduced the need for additional rhythm control interventions in patients with HF and the genotype which responds most favorably to Gencaro.
- ARCA currently has an agreement with the U.S. FDA, known as a Special Protocol Assessment, or SPA, for the requirements of a Gencaro Phase 3 clinical trial, PRECISION-AF, that would support potential approval of Gencaro if successful. The Company is currently evaluating the potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial, and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.
Corporate
- The Company added to its executive team with the hiring of Jeff Dekker as Chief Financial Officer and Christopher Graybill as Vice President, Clinical Development.
Second Quarter 2021 Summary Financial Results
Cash and cash equivalents were $63.2 million as of June 30, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022.
Research and development (R&D) expenses were $3.6 million for the quarter ended June 30, 2021, compared to $0.4 million for the corresponding period in 2020. The $3.2 million increase in R&D expenses in the second quarter was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020. R&D expenses in 2021 are expected to be higher than 2020, as the Company continues the rNAPc2 Phase 2b clinical trial.
General and administrative (G&A) expenses were $1.3 million for the quarter ended June 30, 2021, compared to $0.9 million for the corresponding period in 2020. The $0.3 million increase in G&A expenses was primarily a result of higher personnel costs in 2021. G&A expenses in the second half of 2021 are expected to be consistent with the first half of 2021 as the Company maintains administrative activities to support its ongoing operations.
Total operating expenses for the quarter ended June 30, 2021 were $4.8 million compared to $1.3 million for the second quarter of 2020.
Net loss for the quarter ended June 30, 2021 was $4.8 million, or $0.34 per basic and diluted share, compared to $1.3 million, or $0.73 per basic and diluted share for the second quarter of 2020.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential future development plans for rNAPc2 and Gencaro, the expected features and characteristics of rNAPc2 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, rNAPc2's potential to treat COVID-19, future treatment options for patients with COVID-19 or AF, the potential for Gencaro to be the first genetically targeted AF prevention treatment and the ability of ARCA's financial resources to support its operations through 2022. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected](Tables follow)
ARCA BIOPHARMA, INC.
BALANCE SHEET DATA
(in thousands)
(unaudited)June 30, 2021 December 31, 2020 Cash and cash equivalents $63,197 $49,071 Working capital $61,098 $46,469 Total assets $65,338 $50,429 Total stockholders' equity $61,208 $46,521
ARCA BIOPHARMA, INC.STATEMENTS OF OPERATIONS
(unaudited)Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 (in thousands, except share and per share amounts) Costs and expenses: Research and development $ 3,577 $ 372 $ 6,453 $ 737 General and administrative 1,260 938 2,486 1,913 Total costs and expenses 4,837 1,310 8,939 2,650 Loss from operations (4,837 ) (1,310 ) (8,939 ) (2,650 ) Interest and other income 3 2 5 26 Interest expense — (3 ) — (7 ) Loss before income taxes (4,834 ) (1,311 ) (8,934 ) (2,631 ) Income tax benefit — 9 — 9 Net loss $ (4,834 ) $ (1,302 ) $ (8,934 ) $ (2,622 ) Net loss per share: Basic and diluted $ (0.34 ) $ (0.73 ) $ (0.67 ) $ (1.55 ) Weighted average shares outstanding: Basic and diluted 14,410,143 1,793,900 13,389,207 1,693,985 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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- Analysis in full patient cohort shows Gencaro effect compared to standard of care
- In the GENETIC-AF entire cohort of heart failure patients treated with Gencaro, compared to patients treated with metoprolol succinate (TOPROL-XL), experienced:
- a 36% reduction in cumulative atrial fibrillation burden with a 55% reduction in daily atrial fibrillation burden by the end of the study
- a 32% reduction in the rate of rhythm control clinical interventions, and
- a 39% increase in electrocardiograms demonstrating normal sinus rhythm
- Aspects of these data are the basis for the new patent issued by USPTO for use of Gencaro in treating atrial fibrillation in heart failure patients with ejection fractions greater than 40%, a patient population for whom there are few approved or effective drug therapies
WESTMINSTER, Colo., July 28, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that the paper entitled "Bucindolol [Gencaro] Decreases AF Burden" (Jonathan Piccini, et al), which details a new analysis of the Gencaro Phase 2b data on atrial fibrillation (AF) burden and rhythm control interventions has been published in Circulation: Arrhythmia and Electrophysiology, a journal of the American Heart Association. In the Phase 2b superiority clinical trial, although the prespecified primary endpoint was not met, compared with metoprolol, Gencaro reduced AF burden, increased maintenance of sinus rhythm, and reduced the need for additional rhythm control interventions in patients with heart failure (HF) and the genotype which responds most favorably to Gencaro.
In the trial, the prevalence of electrocardiograms (ECGs) in normal sinus rhythm, AF interventions for rhythm control (electrical cardioversion, catheter ablation and Class III antiarrhythmic drugs), and biomarkers were evaluated in the overall population entering efficacy follow-up (N=257). AF burden was evaluated for 24 weeks in a device substudy (N=67) in which all patients had continuous monitoring of cardiac rhythm by implanted devices.
In 257 patients with HF, the mean age was 65.6 ± 10.0 years, 18% were female, mean left ventricular ejection fraction (LVEF) was 36%, and 51% had persistent AF. Cumulative 24-week AF burden was 24.4% (95% CI: 18.5, 30.2) for bucindolol and 36.7% (95% CI: 30.0, 43.5) for metoprolol (36% reduction, p =0.002). Daily AF burden at the end of follow-up was 15.1% (95% CI: 3.2, 27.0) for bucindolol and 34.7% (95% CI: 17.9, 51.2) for metoprolol (55% reduction, p < 0.001). The prevalence of ECGs in normal sinus rhythm was 4.20 and 3.03 events per patient for the bucindolol and metoprolol groups, respectively (39% increase, p < 0.001); whereas the rate of AF rhythm control interventions was 0.56 and 0.82 events per patient for the bucindolol and metoprolol groups, respectively (32% reduction, p = 0.011). Reductions in plasma norepinephrine (p = 0.038) and NT-proBNP (p = 0.009) were observed with bucindolol compared to metoprolol.
Jonathan Piccini, MD, Associate Professor of Medicine (Cardiology) and Director of the Cardiac Electrophysiology Section at the Duke University School of Medicine and first author of the paper stated, "Atrial fibrillation in heart failure patients is a growing and challenging problem that is badly in need of additional therapies, particularly those that substantially prevent atrial fibrillation while also improving heart failure. Compared to the GENETIC-AF primary endpoint of time to first AF event, the reduction in AF burden measured by continuous device monitoring in a subgroup, increase in sinus rhythm measured by ECG in all patients and the reduction in AF interventions gives a much more comprehensive evaluation of the relative efficacy of bucindolol vs. metoprolol. As clinical investigators, we are eager to take what we've learned in GENETIC-AF and apply it to the planned Phase 3 PRECISION-AF trial."
An additional analysis of these new data confined to patients with ejection fractions of 40% and above showed novel evidence of a clinically significant potential treatment effect for Gencaro in preventing and treating atrial fibrillation in these patients. Patients with this classification of heart failure, known as mildly reduced (HFmrEF) blending into preserved left ventricular ejection fraction (HFpEF) HF, have few approved or effective drug therapies. This novel result provided the basis for a new patent issued to ARCA by the United States Patent and Trademark Office (USPTO) in February 2021 for use of Gencaro in treating AF in the HF population that ARCA plans to enroll in Gencaro's planned Phase 3 development, a population that includes more than half of all HF patients in the United States and Europe. The Company believes this patent would provide effective patent coverage in the United States into 2039. ARCA has filed similar patent applications in other countries.
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "Atrial fibrillation is common in patients with heart failure, where it complicates disease management, and is associated with worse outcomes, including greater rates of heart failure hospitalization, stroke, and death. AF burden is increasingly being recognized as a more sensitive measure of arrhythmia that is closely linked to key clinical outcomes. In the GENETIC-AF Phase 2b clinical trial device substudy and in the entire trial cohort, Gencaro demonstrated favorable treatment effects compared to the comparator arm. We believe these findings, and our observations that the AF prevention effects of Gencaro appear to persist or be enhanced in higher LVEF HF patients, provide the basis for the design of our Phase 3 trial, PRECISION-AF."
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential future development plans for Gencaro and rNAPc2, the expected features and characteristics of Gencaro and rNAPc2, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, rNAPc2's potential to treat COVID-19, future treatment options for patients with COVID-19 or AF, and the potential for Gencaro to be the first genetically targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
- Analysis in full patient cohort shows Gencaro effect compared to standard of care
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- rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients
- Trial expanded to South America, with regulatory approvals for Argentina and Brazil
- Target trial enrollment increased to 160 patients
- Topline trial data anticipated in the fourth quarter of 2021
WESTMINSTER, Colo., July 13, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today provided an update on ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19.
ARCA has received approval from regulatory authorities in Argentina and Brazil to enroll patients in ASPEN-COVID-19. The trial is currently enrolling patients at seven investigative sites in the United States. The Company anticipates enrolling the first South American patients in July 2021.
Trial target enrollment is being increased from 100 to 160 patients in order to maximize the sample size for determining if there are differences in the two rNAPc2 dose regimens being investigated, to minimize variance in the standard of care heparin control arm, in recognition of the study now being conducted in different geographic regions and to account for evolving changes in the clinical course of COVID-19. To date, 77 patients have been enrolled in the trial. The Company also updated its guidance and now anticipates topline data from this international Phase 2b clinical trial in the fourth quarter of 2021.
"With the pandemic continuing to impact patients around the world and the emergence of multiple variants, there remains a critical need for safe, efficacious treatments for hospitalized COVID-19 patients," said Dr. Michael Bristow, ARCA's President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator. "Many pathogenic viruses, including SARS-CoV-2, increase host cell expression of tissue factor, the primary initiator of the extrinsic coagulation pathway that also signals a parallel inflammatory response. rNAPc2 is a high affinity inhibitor of tissue factor, and with its combination of anticoagulant, anti-inflammatory and potential antiviral effects, we believe rNAPc2 may favorably impact clinical recovery of patients hospitalized with COVID-19, and thus has the potential to be a uniquely beneficial therapy for these patients, and possibly for other virus associated diseases. Argentina and Brazil are experiencing a higher COVID-19 case rate than the U.S. and, with their excellent investigators and track record in clinical trials, are logical countries in which to expand the Phase 2 trial and, ultimately, a potential Phase 3 trial."
ASPEN-COVID-19 is a Phase 2b randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin in approximately 160 hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level. The primary endpoint of the trial is the change in D-dimer level from baseline to Day 8 relative to standard of care heparin. Other objectives of Phase 2b are to assess safety and determine the optimal dose regimen of rNAPc2 for Phase 3. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes.
The U.S. Food and Drug Administration (FDA) has designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program. ARCA believes that rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19.
About rNAPc2 (AB201)
rNAPC2 is a small recombinant protein being developed as a potential treatment for RNA virus- associated diseases, initially focusing on COVID-19. rNAPc2 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives rNAPc2 a combination of anti-coagulant, anti-inflammatory and potential anti-viral properties, and therefore may be effective in addressing the impact of viral infections from multiple pathways. rNAPc2 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including in clinical studies for prevention of venous and arterial thrombosis, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, resulting in serious complications. Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that rNAPc2 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating rNAPc2 as a treatment for COVID-19 and other virus associated diseases.About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for rNAPc2, the expected features and characteristics of rNAPc2, the anticipated development timeline for rNAPc2, rNAPc2's potential to treat COVID-19, or any other RNA virus associated disease, whether rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19 and the potential future treatment options and needs for patients with COVID-19. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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WESTMINSTER, Colo., July 09, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that Thomas Keuer, Chief Operating Officer, will present at the Access to Giving Virtual Investor Conference, which is being held virtually July 13-15, 2021.
Access to Giving is a conference themed around investor education and advocacy with 50+ companies presenting, a keynote, three distinctive panels and 1x1 meetings.
ARCA is scheduled to present on Tuesday, July 13, 2021 at 2:00 PM ET. Management will be available for one-on-one meetings to be held throughout the conference. The presentation will be webcast live and available for replay at https://www.webcaster4.com/Webcast/Page/2744/41973.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2b clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.About Access to Giving
Access to Giving is the first-of-its-kind virtual investor conference and will be held July 13th - 15th, 2021. Companies will have the opportunity to tell their story and conduct 1x1's with qualified investors for charity. 100% of monies raised through donations for 1x1 meetings will be given to causes that are focused on financial literacy and financial education.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected] -
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- Provides exclusive world-wide patent rights to the use of rNAPc2 as a potential treatment for COVID-19 and other indications
WESTMINSTER, Colo., July 07, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (NASDAQ:ABIO) today announced it has entered into a patent assignment agreement with the University Medical Center of Johannes Gutenberg University Mainz, Germany. Under the agreement, ARCA receives exclusive world-wide patent rights to the use of rNAPc2 as a potential treatment for COVID-19, and other indications, based on the research and discoveries from the laboratory of Univ.-Prof. Dr. Wolfram Ruf, the Scientific Director and Alexander von Humboldt Professor at the Center for Thrombosis and Hemostasis (CTH) of the University Medical Center Mainz.
rNAPc2 is a recombinant protein therapeutic being developed by ARCA as a potential treatment for COVID-19 and other severe viral infections. ASPEN-COVID-19 is an on-going Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19. The U.S. Food and Drug Administration (FDA) designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program.
Univ.-Prof. Dr. Ruf commented, "We believe our research, combined with the accumulating evidence on the clinical importance of large and small vessel thromboses in COVID-19 infected patients, points to a potentially important role for the tissue factor pathway in viral infection, inflammatory response and the development of coagulopathy. Based on its unique modulation of the tissue factor pathway and the evidence from its prior development, we believe rNAPc2 has the potential to be a beneficial therapy for patients with COVID-19."
Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "We are delighted to continue our collaboration with Dr. Ruf and the researchers at the University Medical Center Mainz to advance the development of rNAPc2 as a potential treatment for patients hospitalized with COVID-19. Despite the availability of vaccines and with the emergence of multiple variants, patients around the world continue to experience severe cases of COVID-19 that require hospitalization. We believe rNAPc2's combination of anticoagulant, anti-inflammatory and antiviral properties give it the potential to be effective in addressing the impact of COVID-19 from multiple pathways. As a potential therapeutic aimed at a host response to a disease syndrome, we believe rNAPc2 has therapeutic potential to be used for future viral outbreaks beyond the current pandemic, even as safe and effective vaccines for SARS-CoV-2 are successfully deployed."
Under the Agreement with the University Medical Center Mainz, ARCA also obtains an option to acquire world-wide patent rights to discoveries related to the use of rNAPc2 as a potential therapeutic for auto-immune disorders such as systemic lupus erythematosus, that involve the presence of anti-phospholipid antibodies linked to tissue factor, as well as the option to acquire patent rights for discoveries relating to other therapeutic uses of rNAPc2. Under the Agreement, ARCA has potential upfront and milestone obligations that could total approximately €1.6 million and royalty obligations in the low single digit range, if rNAPc2 receives regulatory approval and is commercialized.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for severe viral infections, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.About the University Medical Center of the Johannes Gutenberg University Mainz
The University Medical Center of the Johannes Gutenberg University Mainz is the only medical institution of supra-maximum supply in the German state of Rhineland-Palatinate and an internationally recognized science location. Medical and scientific specialists at 60 clinics, institutes and departments work interdisciplinarily to treat more than 350,000 patients per year. Highly specialized patient care, research and teaching are inseparably intertwined. Around 3,400 medicine and dentistry students as well as more than 600 future medical, commercial and technical professionals are trained in Mainz. With a workforce of approximately 8,500 colleagues the University Medical Center Mainz is one of the largest employers in the region and an important driver of growth and innovation. Find more information online at www.unimedizin-mainz.de.Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for rNAPc2 and Gencaro, the expected features and characteristics of rNAPc2 or Gencaro, including the potential for rNAPc2 to treat COVID-19, the potential for genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat AF, future vaccines and/or treatment options for patients with COVID-19, future treatment options for patients with AF, and the potential for Gencaro to be the first genetically targeted AF prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA's financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the Securities and Exchange Commission, including without limitation ARCA's annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.Investor & Media Contact:
Derek Cole
720.940.2163
[email protected]A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740