Longevity biotech’s mitochondrial therapy enters IND

Longevity biotech firm CohBar nominates CB5138 analog as lead clinical candidate for idiopathic pulmonary fibrosis and other fibrotic diseases.

CohBar, a clinical-stage longevity biotech 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 Investigational New Drug (IND)-enabling activities.

Longevity.Technology: IPF is a chronic, progressive, debilitating and usually fatal interstitial lung disease that affects approximately 100,000 people in the US alone. An orphan disease, IPF results in fibrotic scarring of the lungs, which is chronic, progressive, debilitating and usually fatal. There is currently no treatment that can stop or reverse the scarring of the lung and early detection of disease is key to slowing progression.

Mitochondria based therapeutics is 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 (Drs Pinchas Cohen and Nir Barzilai) 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.

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.

“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.

CEO Steven Engle
CohBar’s CEO Steven Engle.

“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,” he continued. “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.”

According to CohBar’s press release, multiple CB5138 Analogs demonstrated positive effects on all study outcomes in the therapeutic mouse model of IPF, 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 (tyrosine protein kinase inhibitor), such as greater reduction in fibrosis, inflammation, collagen and pro-inflammatory cytokines compared with 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 now 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.

CohBar’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 programmes: CB5138 Analogs for fibrotic diseases, CB5064 Analogs for COVID-19 associated ARDS, CB5046 Analogs for CXCR4-related cancer and orphan diseases, and MBT3 Analogs for cancer immunotherapy.

Images courtesy of CohBar