- Achieves FDA Alignment on CMC and Non-Clinical Toxicology Regulatory Path for Nebokitug in PSC
- Preparations for the Nebokitug PSC Phase 3 Clinical Trial Advance as Discussions with Potential Strategic Partners Continue
TEL AVIV, Israel — Chemomab Therapeutics Ltd., (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today reported that it has obtained confirmation from the FDA on two significant development milestones as the company continues to finalize the nebokitug Phase 3 program.
As part of the FDA End-of-Phase 2 (EOP2) review process, Chemomab and the FDA addressed multiple Chemistry, Manufacturing, and Controls (CMC) topics critical to ensuring the quality and consistency of drug supply for the late-stage development and eventual commercialization of nebokitug. Following productive discussions, the FDA indicated agreement with the CMC strategy proposed by Chemomab and its contract manufacturing partner.
Chemomab also engaged in a Type C meeting with the FDA to address the non-clinical fetal and embryo developmental toxicology studies that are part of the new drug regulatory pathway. Importantly, the FDA agreed that this toxicology testing may be conducted in parallel with the nebokitug Phase 3 clinical trial and be submitted as part of the planned Biologics Licensing Application (BLA). This represents a favorable outcome for Chemomab, and the FDA’s flexibility supports the timely advancement of the program.
Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab, commented, “Following up on our positive and constructive interactions with the FDA in December regarding the design of the proposed nebokitug PSC Phase 3 pivotal trial, we have further aligned on two additional significant milestones–CMC requirements needed for manufacturing of drug supply for the “to be marketed” formulation and the timing of non-clinical toxicology testing. We look forward to continuing to work closely with the FDA as we finalize the details of the proposed Phase 3 development program and continue our discussions with potential strategic partners.”
About Nebokitug
Nebokitug (CM-101) is a first-in-class dual activity monoclonal antibody that neutralizes CCL24, a soluble protein that helps drive the inflammatory and fibrotic pathways central to primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases. By inhibiting CCL24, nebokitug blocks immune cell recruitment and fibroblast activation, thereby interrupting the self-reinforcing cycle that results in fibrosis. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of nebokitug in patients, including the Phase 2 SPRING trial in patients with PSC. This study achieved the primary safety endpoint and nebokitug-treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoints. The results of the Open Label Extension portion of the SPRING trial, where PSC patients received nebokitug for up to a total of 48 weeks, confirmed and extended the initial Phase 2 results. Nebokitug has received FDA and EMA Orphan Drug designations for the treatment of PSC and systemic sclerosis and FDA Fast Track status for the treatment of PSC in adults.
About Chemomab Therapeutics Ltd.
Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed nebokitug (CM-101), a first-in-class dual activity monoclonal antibody that neutralizes CCL24 and has demonstrated disease-modifying potential. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of nebokitug in patients. Based on positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), the company is preparing for potential initiation of a nebokitug PSC Phase 3 trial. The design of Phase 3 calls for a single pivotal trial based on a clinical event primary endpoint that provides a clear and streamlined pathway to potential full regulatory approval. Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations for the treatment of PSC. Chemomab’s nebokitug program for the treatment of systemic sclerosis has an open U.S. IND. For more information, visit: chemomab.com.
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