Corbus Pharmaceuticals has just announced that participant enrollment for their Phase 3 trial of lenabasum for dermatomyositis has been completed.
Dermatomyositis
Dermatomyositis (DM) is a rare autoimmune disease. It can involve many systems in the body including cardiac, joints, pulmonary, and gastrointestinal. It is characterized by a distinctive skin rash. Patients experience either chronic DM activity or recurrent flares.
The current treatment’s immunosuppressive nature creates toxicity in the body and has limited efficacy. These treatments include systemic glucocorticoids, glucocorticoid-sparing immunosuppresive therapies, and adrenocorticotropic hormone analogue.
DETERMINE
Researchers are impressed by the fact that this study has finished enrollment on time, even amidst a global pandemic. It says a lot about the unmet need for this patient population.
This Phase 3 investigation has a total of 176 participants. It is the largest study to date of its kind. The investigation is placebo-controlled, double-blind, and randomized. There are trial sites in Asia, Europe, and North America. Participants will either receive 20mg of the therapy 2 times a day, 5mg 2 times a day, or placebo 2 times a day. The study period is 52 weeks with a 4 week follow-up period.
The primary endpoint of this investigation is the level of efficacy of the therapy when compared to the placebo. This is based on the ACR TIS (a composite measure including 6 items) at the 52 week mark.
Researchers are also conducting an open-label extension study to allow participants of the Phase 3 trial to continue the treatment after its end.
Lenabasum
The FDA and the EMA have already granted the therapy Orphan Drug Designation for this indication.
It is a small molecule taken orally that binds to CB2. It works to limit fibrosis and eliminate inflammation in the body. This drug does not supppress the entire immune system unlike current treatments.
Animal models of the therapy have shown positive outcomes in the limiting of inflammation and fibrosis. The same positive animal model results have been found for other illnesses discussed below, including rheumatoid arthritis (RA).
Corbus
Lenabasum is the company’s lead candidate. So far, the therapy has produced positive safety data and has been tolerable in all clinical studies. They are developing it for cystic fibrosis (CF), systemic sclerosis (SSc), as well as systemic lupus erythematosus. In a Phase 2 CF study, the therapy led to a lower rate of pulmonary exacerbations. In a Phase 2 SSc and DM study including patients with current skin issues (but not muscle), patient-reported and physician-assessed outcomes were favorable.
The company is also developing CB-4001 as a potential treatment for nonalcoholic steatohepatitis (NASH) and other conditions. They expect to have initial safety data by the end of this year for this therapy.
As for DETERMINE, the company expects results by the last quarter of 2021.
You can read more about this investigation here.
