Coherus’ Oral Therapy for Relapsing MS Seen to Reduce Brain Lesions by Half in Phase 2b Trial
Coherus BioSciences recently reported that its candidate therapy for multiple sclerosis (MS), CHS-131, reduced the development rate of new brain lesions by nearly 50% in previously untreated relapsing-remitting MS patients.
The Phase 2b trial (NCT02638038), randomizing patients to receive either CHS-131 or placebo in a double-blind manner, also showed the treatment did not give rise to many of the side effects linked to other oral MS drugs.
CHS-131 is the first of a new class of compounds that, in contrast to most MS drugs, has anti-inflammatory effects in the brain without being immunosuppressive — a feature that Coherus believes might make the drug a first-line treatment, either alone or combined with other MS drugs.
“These are exciting results for a new drug with non-immunosuppressive activity that is well-tolerated by patients,” Patricia G. Coyle, MD, vice chair at State University of New York (SUNY) Stony Brook Neurosciences Institute, said in a press release. “This clearly warrants further clinical investigation.” Dr. Coyle is a well-known MS expert and was not a study investigator or a consultant to the company.
The study included 227 patients with relapsing-remitting disease, and compared two doses of the drug, 1 mg and 3 mg, given orally once a day for six months. Participants were assessed through magnetic resonance imaging (MRI) at the study’s start, and again after 24 weeks of treatment — a standard time point for Phase 2 MS clinical trials.
Results showed that patients in the higher dose group had 46.3% fewer new brain lesions compared to control (placebo) individuals.
Safety and tolerability of the treatment was evaluated, with Coherus reporting no specific safety issues. Side effects were reported in equal proportions among placebo- and CHS-131-treated patients.
Although the full results of the trial will not be disclosed until later in 2016, at a scientific conference, Denny Lanfear, president and chief executive officer of Coherus, said enough toxicology data now exists to consider the drug ready for Phase 3 clinical trials.
CHS-131 was previously known under the name INT-131, developed by InteKrin Therapeutics, which Coherus acquired in 2014. The drug has gone through several clinical trials including more than 600 patients with MS and other conditions such as diabetes. The earlier studies all indicated that the treatment is safe and well-tolerated.