Chemomab Receives Supportive Regulatory Guidance In Two Separate FDA Meetings For Advancing Nebokitug To Phase 3 Clinical Development In Primary Sclerosing Cholangitis

Chemomab Therapeutics Ltd., a clinical-stage biotechnology company developing treatments for fibro-inflammatory diseases, has announced confirmation from the U.S. Food and Drug Administration (FDA) on two key development milestones related to its lead drug candidate, nebokitug, as the company works toward launching its Phase 3 clinical program.

During the FDA’s End-of-Phase 2 (EOP2) review, Chemomab and the agency discussed several important Chemistry, Manufacturing, and Controls (CMC) topics aimed at ensuring consistent drug quality during late-stage development and future commercialization. Following these discussions, the FDA agreed with the CMC approach proposed by Chemomab and its manufacturing partner, marking a significant step forward for the program.

Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab, said in a statement, “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.”

In addition, Chemomab recently held a Type C meeting with the FDA to review non-clinical toxicology requirements, specifically those related to fetal and embryo development. The FDA confirmed that these studies can be conducted alongside the Phase 3 trial, rather than beforehand, and their results may be included in the company’s future Biologics License Application (BLA). This agreement is expected to help keep the development of nebokitug on track and potentially accelerate its regulatory timeline.