Chemomab Therapeutics Ltd. (Nasdaq: CMMB) has announced positive results from its CM-101 Phase 2 SPRING trial in patients with primary sclerosing cholangitis (PSC) and provided an update on its corporate strategy, including plans for a Phase 3 registrational trial. The company is set to meet with the FDA in the fourth quarter of 2024 to discuss the design of an accelerated approval Phase 3 trial for CM-101 in PSC.
CM-101 Phase 2 SPRING Trial Results
The Phase 2 SPRING trial evaluated the safety and efficacy of CM-101 in patients with PSC. Topline results, reported on July 25, 2024, indicated that CM-101 met the primary study endpoint, demonstrating a favorable safety profile over the 15-week treatment period. Patients with moderate to advanced disease treated with CM-101 showed improvements in several disease-related secondary endpoints, including:
- Liver stiffness
- Liver fibrosis biomarkers (ELF score and PRO-C3 levels)
- Total bilirubin and liver function tests
- Pruritus (itch)
- Markers of inflammation
Dose-dependent responses were observed for multiple disease-related biomarkers, with the higher 20 mg/kg dose of CM-101 showing a consistent pattern of greater improvement. The open-label extension portion of the SPRING trial is ongoing, with results expected in the first quarter of 2025.
Path to Phase 3 and FDA Discussions
Chemomab is preparing to initiate a Phase 3 registrational trial for CM-101 in PSC, anticipated to launch in late 2025. A meeting with the FDA is scheduled before the end of 2024 to discuss the trial design, with optimism that the proposed design, incorporating surrogate biomarkers as primary endpoints in a single pivotal study, will be accepted. According to Chemomab, positive results across surrogate biomarker endpoints in the Phase 2 SPRING trial may de-risk CM-101's advancement into Phase 3.
Financial Position and Strategic Partnerships
As of September 30, 2024, Chemomab reported $19.5 million in cash and short-term bank deposits, which the company believes will fund operations through early 2026. The company completed a private placement in the third quarter of 2024, resulting in gross proceeds of approximately $10 million. Chemomab is also engaged in active discussions with potential strategic partners to accelerate the PSC clinical program and programs in systemic sclerosis and other fibro-inflammatory diseases.
Management Commentary
"These are exciting and transformational times for Chemomab," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "The positive data from this trial represents a major clinical proof-of-concept for CM-101 as a potential disease-modifying treatment for PSC and other fibro-inflammatory diseases."
Dr. Mor added, "We currently are laying the groundwork for the PSC registrational trial, which we anticipate launching later in 2025. We continue to have active discussions with potential strategic partners... Our goal is to maximize the value of our novel and unique asset for all our stakeholders and ensure that CM-101 is available to patients in need."
