The US Food and Drug Administration (FDA) has granted clearance for Chemomab Therapeutics’ investigational new drug (IND) application to commence the Phase II ABATE clinical trial of CM-101 in systemic sclerosis (SSc) adult patients.

The double-blind, multicentre, proof-of-biology, randomised Phase II trial has been designed for assessing the activity, safety, and tolerability of CM-101 in these patients.

A total of 45 people with clinically active dermatologic, vascular, or pulmonary SSc will be enrolled in the trial.

The participants are anticipated to be roughly split between diffuse cutaneous SSc patients and limited SSc patients.

The ABATE trial will further evaluate the safety and establish biological and clinical proof-of-concept of CM-101 as a potential treatment for SSc.

It includes a double blind period for 24 weeks, during which active treatment patients will receive intravenous infusions of CM-101 10mg/kg every three weeks.

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This will be followed by an open label extension for the same period, where all the participants will receive a CM-101 10mg/kg dose.

The study also includes multiple clinical evaluations of the vasculature, pulmonary function, and skin.

Safety is the trial’s primary outcome measure.

Multiple serum-based biological markers, along with different exploratory biological and clinical outcomes, including the American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) score and its revisions (rCRISS), are some of the secondary endpoints of the trial.

Chemomab chief medical officer Matt Frankel said: “Achieving FDA clearance to initiate our Phase II systemic sclerosis trial is an important milestone for Chemomab.

“We are encouraged by the results of recent clinical studies of CM-101 in Covid patients with SSc-like acute lung injury and in NASH patients, which showed consistent trends in reducing multiple biomarkers associated with fibro-inflammatory disease.

“We believe that CM-101 has the potential to become the first disease-modifying treatment for this debilitating condition that is thought to be the most lethal of the systemic rheumatic disorders.”

The company expects to commence the enrolment of participants in the first half of this year, with top-line data scheduled for the second half of next year.