CohBar Announces First Subjects Dosed in its Phase 1b Clinical Trial for CB4211 Under Development for NASH and Obesity

Rhea-AI Summary

CohBar, Inc. (NASDAQ: CWBR) announced the dosing of the first subjects in the Phase 1b clinical trial for CB4211, targeting NASH and obesity. Conducted on twenty obese participants with NAFLD, the study aims to evaluate the drug's effects on liver fat and body weight over four weeks. This is the first mitochondria-based therapeutic to enter clinical testing, with preclinical studies showing promise in regulating metabolism. CohBar anticipates topline data in Q1 2021, addressing a significant market need, with over 30 million patients affected by NASH in the U.S.

Positive

• First subjects dosed in Phase 1b trial for CB4211 targeting NASH and obesity.
• CB4211 is the first mitochondria-based therapeutic in clinical testing.
• Potential to address a significant unmet medical need for NASH, affecting over 30 million patients in the U.S.
• Preclinical studies demonstrate potential therapeutic synergy with GLP-1 agonists.

Negative

• Trial paused in March due to COVID-19, raising concerns about delays.
• Potential regulatory hurdles could impact the development and approval of CB4211.

MENLO PARK, Calif., Aug. 24, 2020 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, announced today that the first subjects have been dosed with CB4211 in the Phase 1b stage of its Phase 1a/1b clinical trial for NASH and obesity. The Phase 1b study is a double-blind, placebo-controlled evaluation of one dose level of CB4211 given once a day for four weeks in twenty obese subjects with NAFLD. This study is designed to assess the potential effects of CB4211 on liver fat, body weight, and various biomarkers that are relevant to NASH, obesity and metabolic disease. Subjects are required to have a minimum of 10% liver fat at enrollment, and to stay in the clinical study unit during the four weeks of treatment. The study resumed in July after a pause in March due to the COVID-19 pandemic.

CB4211 is the first mitochondria based therapeutic to enter clinical testing. Mitochondria based therapeutics are an emerging class of drugs based on novel analogs of peptide sequences discovered by CohBar scientists in the mitochondrial genome, some of which have been shown to have the potential to regulate key processes in multiple systems and organs in the body.

“We are pleased to have made another key step towards evaluating the therapeutic potential of CB4211 and our technology platform,” said Steven Engle, CohBar’s Chief Executive Officer. “NASH is a complex disease with a large and growing unmet medical need with over 30 million patients at risk and no approved treatments in the U.S. Experts believe that more than one treatment approach will be needed, similar to the way other diseases are treated, like diabetes. We believe CB4211 is well positioned because it has a mechanism of action that is different from any other potential NASH treatment now in clinical development. In addition, it has demonstrated in preclinical studies a potential therapeutic synergy with GLP-1 agonists, which are already used in many diabetic NASH patients. We look forward to completing this study with topline data currently projected in Q1 2021 within the constraints currently imposed by COVID-19 on the study.”

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT), that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial derived peptide (MDP), which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. NASH has been estimated to affect as many as 30 million adults in the U.S., and there is currently no approved treatment for the disease.

About CohBar

CohBar (NASDAQ: CWBR) is a clinical stage biotechnology company focused on the research and development of mitochondria based therapeutics, an emerging class of drugs for the treatment of chronic and age-related diseases. Mitochondria based therapeutics originate from the discovery by CohBar’s founders of a novel group of naturally occurring peptide sequences within the mitochondrial genome, some of which have been shown to have the potential to regulate key processes in multiple systems and organs in the body. To date, the company has discovered more than 100 mitochondrial derived peptides and generated over 1,000 analogs. CohBar’s efforts focus on the development of these peptides into therapeutics that offer the potential to address a broad range of diseases because of the underlying impact of mitochondrial dysfunction. The company’s lead compound, CB4211, is in the Phase 1b stage of a Phase 1a/1b clinical trial for NASH and obesity. In addition, CohBar currently has four preclinical programs: CB5138 Analogs for fibrotic diseases, CB5064 Analogs for COVID-19 associated ARDS and type 2 diabetes, MBT5 Analogs for CXCR4-related cancer and orphan diseases, and MBT3 Analogs for cancer immunotherapy.

Forward-Looking Statements

This news release contains forward-looking statements which are not historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “should,” “would,” “project,” “plan,” “expect,” “goal,” “seek,” “future,” “likely” or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to statements regarding the impact of COVID-19 on our ongoing and planned clinical trials; anticipated outcomes of research and clinical trials for our mitochondria based therapeutic (MBT) candidates; expectations regarding the growth of MBTs as a significant future class of drug products; and statements regarding anticipated therapeutic properties and potential of our mitochondrial peptide analogs and MBTs. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include: our ability to successfully advance drug discovery and development programs, including the delay or termination of ongoing clinical trials; our possible inability to mitigate the prevalence and/or persistence of the injection site reactions, receipt of unfavorable feedback from regulators regarding the safety or tolerability of CB4211 or the possibility of other developments affecting the viability of CB4211 as a clinical candidate or its commercial potential; results that are different from earlier data results including less favorable than and that may not support further clinical development; our ability to raise additional capital when necessary to continue our operations; our ability to recruit and retain key management and scientific personnel; the risk that our intellectual property may not be adequately protected; our ability to establish and maintain partnerships with corporate and industry partners; and risks related to the impact on our business of the COVID-19 pandemic or similar public health crises. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission and applicable Canadian securities regulators, which are available on our website, and at www.sec.gov or www.sedar.com. You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this news release are made as of the date hereof and CohBar does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.

Contacts:
Jordyn Tarazi
Director of Investor Relations
CohBar, Inc.
(650) 445-4441
Jordyn.tarazi@cohbar.com

Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

FAQ

What is the purpose of CohBar's CB4211 clinical trial?

The trial aims to evaluate the effects of CB4211 on liver fat, body weight, and biomarkers relevant to NASH and obesity.

When is the projected topline data for the CB4211 trial expected?

CohBar anticipates topline data in Q1 2021.

How does CB4211 differ from other NASH treatments?

CB4211 operates through a unique mechanism of action, different from other treatments currently in clinical development.

What are the implications of the Phase 1b trial for investors in CWBR?

Successful trial outcomes could significantly enhance CohBar's market position and potentially lead to increased stock value.