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TEL AVIV - Chemomab Therapeutics Ltd. (NASDAQ:CMMB), a clinical stage biotechnology company with a market capitalization of $36.77 million, has announced alignment with the U.S. Food and Drug Administration (FDA) on a Phase 3 trial design for nebokitug, potentially the first FDA-approved treatment for primary sclerosing cholangitis (PSC). The company’s stock has shown remarkable strength, delivering a 206.4% return over the past year, according to InvestingPro data. This development follows the successful completion of an End-of-Phase 2 meeting with the FDA.
The Phase 3 trial will not require liver biopsies, instead focusing on clinical events related to PSC disease progression. This approach could accelerate the timeline to full regulatory approval, as it eliminates the need for additional confirmatory studies. The trial is set to include approximately 350 PSC patients and will assess the time-to-first-event of a number of PSC clinical events to demonstrate statistically significant changes between the treatment and placebo arms. While the company maintains a strong financial position with a current ratio of 4.57 and minimal debt, InvestingPro analysis shows it is not yet profitable, with an EBITDA of -$15.31 million in the last twelve months.
Nebokitug, recently designated by the World Health Organization’s International Nonproprietary Names program, is a monoclonal antibody targeting CCL24, a protein involved in fibro-inflammatory diseases. The drug has shown favorable safety profiles and potential disease-modifying activity in previous clinical and preclinical studies.
Dr. Adi Mor, CEO of Chemomab, expressed confidence in the relevance of the Phase 3 trial’s endpoint, which is supported by published data associating biomarker improvements with reductions in PSC clinical events. The company expects to report topline data from the open label extension of the Phase 2 SPRING trial before the end of the first quarter.
Christopher Bowlus, MD, at the University of California Davis School of Medicine, highlighted the importance of the trial’s focus on clinically relevant events, expressing optimism for the potential benefits of nebokitug for PSC patients.
Chemomab is actively discussing with potential strategic partners as it prepares for the Phase 3 trial, which could potentially launch before year’s end. The trial will also capture key biomarkers such as elastography and ELF score as additional indicators of clinical outcomes.
The company’s announcement is based on a press release statement and reflects a significant step towards addressing the unmet medical needs of PSC patients, a rare and progressive liver disease with no FDA-approved therapies to date. Analysts maintain an optimistic outlook, with price targets ranging from $4 to $11 per share. For deeper insights into Chemomab’s financial health and growth prospects, including 8 additional ProTips and comprehensive valuation metrics, visit InvestingPro.
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