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Chemomab Therapeutics Announces Year End and Fourth Quarter 2024 Financial Results and Provides a Corporate Update

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Chemomab Therapeutics
Chemomab Therapeutics

Completed Successful FDA End-of-Phase 2 Meeting Following Positive Nebokitug Phase 2 SPRING Trial Results in Primary Sclerosing Cholangitis (PSC)

Achieved Alignment with FDA on Clear and Efficient Pathway to Potential Regulatory Approval for the Treatment of PSC with No Liver Biopsies or Confirmatory Studies Needed; Nebokitug Positioned to Potentially Become the First FDA-Approved Treatment for PSC

On Track for Releasing Clinical Data from SPRING Trial Open Label Extension in First Quarter 2025─

─Discussions with Potential Strategic Partners Ongoing

TEL AVIV, Israel, March 03, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq:CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the full year and fourth quarter ended December 31, 2024, and provided a corporate update.

“The past year has been a transformative period for both Chemomab and the PSC field,” said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. “Following rapid enrollment in our nebokitug (CM-101) Phase 2 SPRING trial in patients with PSC, we were able to report topline results in July, approximately six months ahead of schedule. We and our PSC expert advisers view these Phase 2 data as the strongest in PSC to date. Nebokitug achieved the SPRING trial primary endpoint, demonstrating a favorable safety profile. Additionally, patients treated with nebokitug who had moderate/advanced disease showed improvements in multiple secondary efficacy endpoints encompassing the fibrotic, inflammatory and cholestatic aspects of PSC. This is the first time that an investigational drug for PSC has shown improvements across such a wide range of highly relevant disease markers. These promising results set the stage for our FDA End-of-Phase 2 meeting. We recently reported the positive results of that meeting and outlined the design for a single pivotal Phase 3 trial for nebokitug in PSC, which provides us with a clear and streamlined pathway to potential regulatory approval.”

Dr. Mor continued, “We were very pleased by FDA’s positive and collaborative spirit at the meeting and their stated commitment to facilitating the advancement of effective new therapies for PSC. We aligned on a full regulatory approval program for nebokitug using a single pivotal Phase 3 trial based on well-characterized clinical events that are associated with disease progression in PSC. Neither liver biopsies nor additional confirmatory studies will be needed. The design is similar to the approach used in oncology trials and is both feasible and efficient. Importantly, use of a clinical event-driven endpoint helps derisk the Phase 3 trial, since key publications have linked the type of improvements in PSC biomarkers seen in nebokitug-treated patients in the SPRING trial with decreases in clinical events.”