Nebokitug shows promise in PSC treatment in Phase 2 trial

TEL AVIV, Israel and SAN DIEGO - Chemomab Therapeutics, Ltd. (NASDAQ:CMMB), a $26.78 million market cap biotech company currently rated as undervalued by InvestingPro models, has announced positive results from its Phase 2 SPRING trial of nebokitug in treating primary sclerosing cholangitis (PSC), a chronic liver disease. The data, presented at Digestive Disease Week® 2025, indicates that nebokitug is safe and shows potential as a disease-modifying treatment. The company’s stock has shown remarkable strength, delivering a 91.89% return over the past year.

The trial data revealed that nebokitug was well-tolerated over a 48-week treatment period and demonstrated significant improvements in fibrotic and inflammatory biomarkers. These biomarkers are associated with the progression of PSC, a disease for which there are currently no FDA-approved therapies. With analyst price targets ranging from $7 to $11, significantly above the current trading price, market expectations appear aligned with the treatment’s potential. Discover more detailed analysis and 7 additional key insights about CMMB with InvestingPro.

During the 15-week double-blind phase of the trial, nebokitug’s safety profile was comparable to placebo, and it showed anti-inflammatory, anti-fibrotic, and anti-cholestatic effects. A subsequent open-label extension showed that patients continued to see improvements or stabilization in liver health markers, particularly those with moderate to advanced disease receiving a 20 mg/kg dose. The company maintains a strong financial position with a healthy current ratio of 4.98 and more cash than debt on its balance sheet, providing runway for continued development.

Paul J. Pockros, MD, a SPRING trial investigator, expressed optimism about the findings, supporting the progression of nebokitug into Phase 3 clinical studies. Adi Mor, PhD, co-founder and CEO of Chemomab, echoed this sentiment, highlighting the significance of the data for advancing the treatment to potentially become the first FDA-approved therapy for PSC.

The company is now preparing for a Phase 3 trial, which is anticipated to have a clear pathway to regulatory approval based on a clinical event primary endpoint. Nebokitug has already received Orphan Drug and Fast Track designations from the FDA and EMA for the treatment of PSC.

Chemomab is focusing on developing therapeutics for fibro-inflammatory diseases and has reported favorable outcomes from multiple clinical trials of nebokitug. The full presentation from DDW 2025 is available on the R&D pages of the Chemomab website.

This article is based on a press release statement from Chemomab Therapeutics.

In other recent news, Chemomab Therapeutics has reported significant findings from its Phase 2 SPRING trial of nebokitug for the treatment of primary sclerosing cholangitis (PSC). The trial data demonstrated dose-dependent improvements in inflammatory and fibrotic biomarkers, indicating potential for nebokitug as a novel treatment. The company has also announced positive results from a Phase 2 trial extension, where patients showed continued improvement in key liver biomarkers after 48 weeks of treatment. This extension confirmed nebokitug’s safety and tolerability, with significant reductions in liver stiffness compared to historical controls. Additionally, Chemomab has aligned with the FDA on a Phase 3 trial design for nebokitug, potentially the first FDA-approved treatment for PSC. This trial will focus on clinical events related to PSC disease progression, aiming to accelerate regulatory approval. The drug has received FDA and EMA Orphan Drug designations and FDA Fast Track status, highlighting its potential significance in treating PSC. Chemomab is preparing for the Phase 3 trial, which could launch before the end of the year, marking a crucial step towards addressing the unmet medical needs of PSC patients.

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