CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, today announced new preclinical data demonstrating that combination of a CB5138 Analog with nintedanib, the leading standard of care for treatment of Idiopathic Pulmonary Fibrosis (IPF), produced enhanced effects compared to nintedanib alone in mice. The new data from the therapeutic mouse model of IPF showed that treatment with the combination of CB5138-2 and nintedanib produced greater reductions in fibrosis, inflammation, pro-inflammatory cytokine levels, and collagen deposition.
"The new data provide clear evidence that the unique mechanism of action of CohBar's antifibrotic peptides has the potential to be combined effectively with an existing treatment to achieve even greater effects," said Kenneth C. Cundy, PhD, CohBar's Chief Scientific Officer. "We previously demonstrated the efficacy of CB5138 Analog peptides administered alone in both the prevention and treatment of fibrosis in preclinical models of IPF, and we now have compelling data further supporting their clinical potential. We plan to present the data in an upcoming KOL meeting as we continue to move the program towards final selection of a clinical candidate."
In the mouse study, fibrosis was induced by intratracheal administration of bleomycin and treatment with vehicle (placebo), CB5138-2, nintedanib, or the combination of the two drugs was initiated seven days later, after fibrosis was established. After 14 days of treatment, the resulting effects on lung fibrosis, inflammation, collagen deposition and secretion of proinflammatory cytokines into lung fluid were measured. Compared to nintedanib alone, the combination of CB5138-2 and nintedanib produced greater reductions in Ashcroft lung fibrosis score, inflammation, collagen secretion and deposition, and secretion of key pro-inflammatory cytokines.
"Despite the current availability of two approved drugs, nintedanib and pirfenidone, IPF patients are still dying of respiratory failure and there is a major unmet medical need for better treatments," stated Professor Toby Maher, Director of Interstitial Lung Disease and Professor of Medicine at the Keck School of Medicine, University of Southern California. "It is anticipated that any new drug for IPF will be used in conjunction with the current standard of care. These exciting new preclinical results suggest that combination of CohBar's peptides with nintedanib has the potential to achieve enhanced effects in IPF patients."
Further details of these new data will be available on the CohBar website at www.cohbar.com.
Key Opinion Leader Webinar on IPF
CohBar will host a Key Opinion Leader webinar on the current treatment landscape in IPF, the unmet medical need, and positive findings from preclinical studies of CohBar's CB5138 Analogs on Friday, November 6 at 2:00pm ET. Interested parties can register for the event here.
About CB5138 Analogs for IPF and other Fibrotic Diseases
CB5138 Analog peptides are modified analogs of a natural peptide sequence encoded in mitochondrial DNA. Data on the efficacy of CB5138 Analog peptides in preclinical models of IPF were recently presented at the American Thoracic Society Virtual Annual Meeting in August 2020. In co-cultures of human lung cells, CB5138-1 decreased the expression of key fibrosis biomarkers, including alpha smooth muscle actin (Î±SMA), and collagen types I and III. CB5138-1 also decreased the transformation of healthy lung cells into fibrotic cells after induction by TGF-beta1, resulting in reduced production of the fibrotic components Î±SMA and pro-collagen I alpha 1. In vivo, CB5138-1 decreased lung fibrosis and inflammation in both the prophylactic mouse model of IPF, initiating treatment with the peptide immediately after fibrosis induction by bleomycin, and in the therapeutic mouse model of IPF, starting peptide treatment one week after induction. In addition, using the more exacting therapeutic model of IPF, two new analogs of CB5138 (CB5138-2 and CB5138-3) significantly reduced lung fibrosis assessed by the Ashcroft Score, reduced inflammation, and decreased fibrosis-related changes in lung weight, collagen deposition in lung tissue, and collagen secretion into lung fluid.
Idiopathic Pulmonary Fibrosis (IPF) is a chronic, progressive, debilitating and usually fatal interstitial lung disease that affects approximately 100,000 people in the U.S. This orphan disease results in scarring of the lungs, also known as fibrosis. While there are two approved treatments that can help slow the progression of IPF, there is currently no treatment that can stop or reverse the scarring of the lung. On average, patients diagnosed with IPF live between two and five years from diagnosis.
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 has four preclinical programs: CB5138 Analogs for fibrotic diseases, CB5064 Analogs for COVID-19 associated ARDS, MBT5 Analogs for CXCR4-related cancer and orphan diseases, and MBT3 Analogs for cancer immunotherapy.
For additional company information, please visit www.cohbar.com.
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 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, MBTs and other potential therapies, including but not limited to in the treatment of IPF. 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.
Director of Investor Relations
LifeSci Advisors, LLC