Thursday, Chemomab Therapeutics Ltd ( CMMB ). released topline results from the Phase 2 SPRING trial assessing its monoclonal antibody, CM-101, in patients with primary sclerosing cholangitis (PSC).

Treatment with CM-101 achieved its primary endpoint of safety and tolerability.

It demonstrated anti-fibrotic, anti-inflammatory, and anti-cholestatic effects across various disease-related secondary efficacy endpoints, including statistically significant improvement in liver stiffness.

CM-101 demonstrated a favorable safety profile and was generally well-tolerated over the 15-week treatment period. It also exhibited favorable and dose-dependent pharmacokinetic profiles.

Adverse events, which most commonly included fatigue, headache, and pruritis, were generally mild/moderate and distributed similarly between the placebo and CM-101-treated dosing arms.

Both doses of CM-101 improved liver stiffness relative to placebo at Week 15, with a statistically significant improvement achieved in patients with moderate/advanced disease.

Pruritis (itch) total scores relative to placebo improved in CM-101-treated patients, who demonstrated decreased pruritis scores compared to placebo starting as soon as six weeks after their first dose.

CM-101-treated patients experienced decreased pruritis scores across all time points compared to placebo, and the decrease reached statistical significance in patients receiving the 10 mg/kg dose at Week 15.

All liver function tests improved in CM-101-treated patients relative to placebo at Week 15.

Chemomab is preparing for an End-of-Phase 2 meeting with the FDA to discuss the SPRING trial results and the design of a proposed Phase 3 PSC trial for accelerated approval.

The company anticipates completing these discussions by the end of the year and receiving official written feedback from the FDA in the first quarter of 2025.

An Open-Label Extension portion of the SPRING trial, which allows patients to receive CM-101 for an additional 33 weeks, is ongoing.

Topline treatment results from this portion of the study, including patients with up to 48 weeks of exposure to CM-101, are on track to be reported in the first quarter of 2025.

Concurrently, Chemomab Therapeutics ( CMMB ) announced a private investment in public equity of approximately $10 million via selling 4.19 million ADSs at $1.235 per share and pre-funded warrants to purchase up to 3.91 ADSs at a $1.235/warrant.

Price Action: CMMB stock is down 14.80% at $1.21 at the last check on Thursday.

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