CohBar has chosen CB5138-3 as its lead treatment candidate for idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases, based on its promising safety, efficacy, and drug-like properties in preclinical studies.
The company is planning to further test this peptide — a small protein fragment — in early studies needed to move it into testing in people. A company goal is to initiate a clinical trial of CB5138-3 in 2022.
“We look forward to the possibility of providing a new treatment option for this devastating disease [IPF] and exploring the therapeutic potential of CB5138-3 as a treatment of other fibrotic diseases, including other interstitial lung diseases,” Steven Engle, CohBar’s CEO, said in a press release.
CB5138-3 belongs to a new class of molecules known as CB5138 Analogs. These are modified versions of a naturally occurring peptide found in mitochondria, the small cell compartments that are responsible for energy production and are often referred to as “cellular powerhouses.”
Mitochondrial dysfunction occurs in multiple disorders, including IPF. According to the company, several CB5138 Analogs have shown positive effects in an IPF mouse model. These include reductions in inflammation, tissue scarring (fibrosis), and collagen accumulation. Collagen is one of the main components of the extracellular matrix — the network of molecules that surrounds and supports cells — and its excessive production is a major contributor to tissue scarring.
Data release last year showed that CB5138-2 — another CB5138 Analog — given in combination with Ofev (nintedanib), an approved IPF therapy marketed by Boehringer Ingelheim, was superior to Ofev alone at easing IPF symptoms in a mouse model of the disease.
“Our positive preclinical data in models of IPF support the further development of CB5138-3 as a potential anti-fibrotic 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,” Engle said.
“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,” Engle added.
CohBar reports that its proprietary platform technology allows it to rapidly screen and identify mitochondrial peptides with a strong therapeutic potential. Those identified are then engineered to further enhance treatment-relevant properties. These engineered peptides, which are optimized versions of naturally occurring molecules, are referred to as analogs due to their similarities with the original peptides they were based on.
In a candidate screening, CB5138-3 emerging as the most promising analog based on its preliminary efficacy, safety, and drug-like properties, CohBar announced in the release.
The company also plans to test the potential of its CB5138 Analogs in animal models of other fibrotic disorders — including nonalcoholic steatohepatitis, systemic sclerosis, and kidney fibrosis — which according to Eagle “are collectively responsible for 45% of deaths in the developed world.”
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