CohBar, Inc. (NASDAQ:CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, today announced the selection of CB5138-3 as its lead candidate for advancement into IND-enabling activities. CB5138-3 is a CB5138 Analog, a novel class of molecules derived from a natural, mitochondrially encoded peptide source discovered by CohBar, with potential for treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases. 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 fibrotic scarring of the lungs.
"Nominating our second clinical candidate is an exciting milestone for CohBar and provides additional confirmation of the potential of our novel discovery platform for mitochondria based therapeutics," stated Steven Engle, CohBar's Chief Executive Officer. "Our positive preclinical data in models of IPF support the further development of CB5138-3 as a potential antifibrotic and anti-inflammatory therapeutic for IPF, which remains an unmet medical need with few treatment options. Drugs currently approved for IPF can slow the progression of disease but can also cause significant side effects that limit their use. We look forward to the possibility of providing a new treatment option for this devastating disease and exploring the therapeutic potential of CB5138-3 as a treatment of other fibrotic diseases, including other interstitial lung diseases. Fibrotic diseases can affect any organ and are collectively responsible for 45% of deaths in the developed world."
In the therapeutic mouse model of IPF, multiple CB5138 Analogs demonstrated positive effects on all study outcomes, including reduction of fibrosis, inflammation, and collagen deposition. CohBar also showed enhanced effects for a CB5138 Analog in combination with the standard of care nintedanib, such as greater reduction in fibrosis, inflammation, collagen, and pro-inflammatory cytokines compared to nintedanib alone. CohBar has now completed candidate screening activities and selected CB5138-3 as the lead CB5138 Analog for further development based on its preclinical efficacy data, preliminary safety profile, and drug-like properties.
CohBar will move forward with IND-enabling activities for CB5138-3 with the goal of initiating clinical studies in 2022. In addition, the company is continuing to evaluate the efficacy of the CB5138 Analogs in models of other fibrotic diseases such as NASH, systemic sclerosis, and kidney fibrosis. Fibrosis can occur in the lungs, brain, liver, heart, and other organs.