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Chemomab (CMMB) Mid-Stage Study for NASH Meets Primary Goal

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Chemomab Therapeutics, Ltd. (CMMB - Free Report) announced that its mid-stage study evaluating CM-101 in non-alcoholic steatohepatitis (NASH) patients was successful.

CM-101 is a monoclonal antibody designed to bind and block CCL24 activity.

The randomized, placebo-controlled phase IIa study enrolled 23 NASH patients with stages F1c, F2 and F3 disease, who were randomized to receive either CM-101 or placebo. Patients received eight doses of 5 mg/kg of CM-101 or a placebo, administered by subcutaneous (SC) injection once every two weeks for a treatment period of 16 weeks. This trial was primarily designed to assess the subcutaneous formulation of CM-101 and to evaluate the drug's impact on liver fibrosis biomarkers relevant to both NASH and the rare fibro-inflammatory conditions such as primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).


The trial met its primary endpoint of safety and tolerability, and CM-101 achieved reductions in secondary endpoints that include a range of liver fibrosis biomarkers and physiologic assessments measured at baseline and at week 20.

Shares of the company gained on the news. However, the gains were pared and the stock ended in red on Jan 3 and was down 8.12%. Shares of the company have plunged 58.8% in the past year compared with the industry’s decline of 20.4%.

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Per the company, this is the third study in patients demonstrating the activity of CM-101 as measured by fibro-inflammatory biomarkers and physiological assessments.

The candidate is currently in phase II studies for PSC and liver fibrosis.

In November 2022, Chemomab presented clinical data that showed that CM-101 was safe and well-tolerated and achieved reductions in biomarkers associated with lung inflammation and fibrogenesis in a clinical study in patients hospitalized with COVID-19-derived lung injury.

The successful development of the candidate will be a significant boost for the company, as NASH is a challenging but promising market.

Given the potential in the market, quite a few players are trying to develop a successful treatment for it.

Madrigal Pharmaceuticals, Inc. (MDGL - Free Report) skyrocketed significantly on Dec 19 after the company announced positive top line results from the phase III MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. The study achieved both liver histological improvement endpoints as proposed by the FDA, which is likely to predict clinical benefit to support accelerated approval of resmetirom for treating NASH with liver fibrosis. Madrigal intends to file a new drug application (NDA) seeking accelerated approval of resmetirom for treating non-cirrhotic NASH with liver fibrosis.

Intercept Pharmaceuticals (ICPT - Free Report) is evaluating obeticholic acid (OCA) for NASH. In June 2022, ICPT announced positive top-line data from a new interim analysis of its pivotal phase III REGENERATE study, evaluating the efficacy of OCA in patients with liver fibrosis due to NASH. Based on the study’s results, Intercept will resubmit its NDA for OCA to treat liver fibrosis due to NASH.

Another company, Viking Therapeutics (VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. VKTX is evaluating VK2809 in a phase IIb study in patients with NASH. 

Chemomab currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.


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