Phase 2 SPRING Trial in Primary Sclerosing Cholangitis

Chemomab has completed the Phase 2 SPRING trial assessing nebokitug as a potential treatment for primary sclerosing cholangitis (PSC). The successful trial results showed that treatment with nebokitug achieved its primary endpoint of safety and tolerability and demonstrated broad, clinically-relevant anti-fibrotic, anti-inflammatory and anti-cholestatic effects across a broad range of disease-related secondary endpoints.

The double-blind, placebo-controlled portion of the SPRING study assessed two doses of nebokitug (10 mg/kg and 20 mg/kg) administered to PSC patients every three weeks over 15 weeks. A total of 76 patients were treated in the trial. The study analysis included assessments of all study completers, as well as a prespecified subgroup analysis of moderate/advanced patients with a higher risk of more rapidly progressing disease. Nebokitug-treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoints, including assessments of changes from baseline relative to placebo at Week 15 in liver stiffness (transient elastography); in liver fibrosis biomarkers, including the Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels; in total bilirubin and liver function tests; in pruritis (itch) and in markers of inflammation. A consistent pattern of greater improvement on the secondary endpoints was observed in the study arm receiving 20 mg/kg of nebokitug and in the prespecified subgroup of PSC patients with moderate/advanced disease.

The Open Label extension (OLE) portion of the SPRING trial was open to all eligible study participants, who received either 10 or 20 mg/kg of nebokitug for an additional 33 weeks, for up to 48 weeks of treatment. The results confirmed that the drug was safe and well-tolerated and resulted in positive effects, including continued improvements in key liver biomarkers such as the ELF score, the fibrosis-related components of ELF and PRO-C3. Liver stiffness scores were substantially lower in the nebokitug-treated patients with moderate/advanced disease compared to historical controls. Cholestasis-related markers stabilized over 48 weeks of treatment and total serum bile acids were reduced. OLE patients with moderate/advanced disease treated with nebokitug for 48 weeks showed a significantly lower number of clinical events (4.8%) compared to historical controls (25.8%).

Based on these successful results, Chemomab and the FDA have aligned on the overall design for a single global Phase 3 pivotal trial of nebokitug in PSC. If successful, this trial could support regulatory approval in the U.S. and other territories. The study protocol is being finalized with the FDA and preparations for initiating the trial are continuing. For more information on the status of the nebokitug Phase 3 PSC trial, please check the Chemomab website.

For more information on the Phase 2 SPRING trial, visit:

NIH number: NCT04595825

To learn more about how nebokitug (CM-101) may interrupt the fibro-inflammatory vicious cycle believed to drive disease progression in PSC, see our Mechanism of Action (MOA) video at: MOA video

EXPANDED ACCESS POLICY

Chemomab Therapeutics Ltd. (Chemomab) is a clinical-stage biotech company focusing on the discovery and development of innovative therapeutics for patients with serious and debilitating fibrotic-inflammatory diseases with high unmet medical need. Its investigational agent CM-101 is currently being developed for fibrotic-inflammatory conditions such as primary sclerosing cholangitis and systemic sclerosis.

In general, new therapeutics must be reviewed and approved by a regulatory authority, such as the U.S. Food and Drug Administration (FDA), before they become commercially available. These regulatory determinations are based on data from clinical trials designed to evaluate whether the new therapeutic is safe and effective for patients. Investigational drug products that have not completed the clinical trial and FDA regulatory review process may, or may not, be effective as a treatment, and the use of such investigational products may cause unexpected serious side effects.

Expanded access, also called compassionate use, refers to a pathway in which patients with serious or immediately life-threatening diseases may gain access to an investigational therapy outside the context of participation in clinical trials. Wherever possible, we encourage patients to participate in clinical trials, which offer the safest and best opportunity to access an investigational product before regulatory approval. We recognize that some patients who may not be eligible to participate in our clinical trials and have exhausted all available treatment options, may seek to receive CM-101 or other investigational drugs, under an expanded access protocol, before they are approved by regulatory authorities.

Chemomab is committed to evaluation of its drug candidates through the clinical trial process. At this time, Chemomab is not accepting any requests for expanded access to any of our investigational drug candidates outside of clinical trials.

Chemomab may revise this expanded access policy at any time.

Healthcare professionals and patients seeking additional information may contact us at med.info@chemomab.com.