Chemomab Therapeutics is putting its non-alcoholic steatohepatitis (NASH) on hold and focusing on the development of CM-101 in primary sclerosing cholangitis (PSC), CEO Dr Adi Mor told Clinical Trials Arena.

CM-101 is a first-in-class humanised monoclonal antibody designed to bind and block CCL24 activity, which is a key regulator in the fibrotic-inflammatory process.

Mor explained that although the Phase IIa NASH clinical trial showed promising results, the company is shifting gears based on its resources and a vast amount of preclinical data in PSC.

She said: “We see that data from this Phase IIa NASH trial is very translatable to what you would expect to see in PSC.”

Even though Chemomab has ceased chasing NASH at this moment, the company may consider returning to this indication, whether in a partnership or other opportunities, in the future.

Next steps for CM-101

While CM-101 is currently being investigated in a Phase IIa PSC trial, Chemomab is starting to set out plans for a potentially pivotal Phase III trial, with an estimated start date in 2025.

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The exact dosing regimens and the duration of the trial will solely depend on the data from the Phase IIa trial, declared Mor. The company expects to release topline data in H2 2024.

In terms of outcome measures, Mor explained that a couple of late-stage trials, such as Dr Falk’s ongoing norUrsodeoxycholic Acid study (NCT03872921) and the terminated Gilead’s cilofexor (NCT03890120), used endpoints that included liver biopsies.

However, there are ongoing discussions with regulators about potential endpoints that are not necessarily derived from a liver biopsy, which may pose risks, especially in a patchy disease such as PSC. Mor noted that new endpoints might be a combination of imaging and biomarkers or just a variety of biomarkers alone.

Mor said: “Once we see the data from the Phase IIa trial, we can go into a discussion with FDA and decide together with them on what is the right endpoint for our Phase III study.”

Ongoing Phase IIa trial in PSC

Recently, Chemomab presented two scientific posters supporting the clinical rationale for its PSC programme at the Annual Congress of the European Association for the Study of the Liver (EASL) 2023. One of the posters looked at the design of the two-part Phase IIa trial (NCT04595825).

The first part of the trial is a double-blind period with 15 weeks of treatment followed by an open-label part. Chemomab is looking at various biomarkers that would measure fibrogenesis and inflammation. The company enrolled its first patient into the trial in 2021.

Chemomab expects to recruit 68 patients in approximately 50 sites in Europe, Israel and the US.

Mor explained: “It’s a rare disease, so in order to be able to recruit patients efficiently, we opened multiple sites in multiple territories.”