Biopharmaceutical company Receptos, Inc. has enrolled the first participant with relapsing multiple sclerosis (RMS) in its SUNBEAM phase 3 trial, which will evaluate the potential therapy RPC1063 in patients who suffer from the disease. The company’s phase 3 RADIANCE trial, also involving RMS patients, had already been initiated, which means that Receptos may be able to finish its clinical development program for multiple sclerosis by 2017, according to the company’s press release.
RPC1063 is a novel, oral, once daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator being developed by Receptos for the treatment of autoimmune indications such as RMS, but also ulcerative colitis (UC) as well. “Our initiation of the SUNBEAM trial represents another major corporate milestone for Receptos, and positions RPC1063 as the potential next-to-market oral agent for the treatment of relapsing multiple sclerosis,” said the president and chief executive officer of Receptos, Faheem Hasnain.
Both the SUNBEAM and RADIANCE trials are randomized, double-blind studies that will include 1,200 RMS patients, and are designed to compare 0.5 mg and 1.0 mg doses of RPC1063 with interferon beta-1a (Avonex). In addition, the trials aim to evaluate RPC1063’s superiority in comparison with Avonex regarding the decrease of the annualized relapse rate following either one or two years of therapy. Both of the phase 3 trials are taking place under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
The RPC1063 therapy had already been demonstrated to be promising for treatment of MS, as it met the primary endpoint of reduction in MRI brain lesion activity and secondary endpoints measuring effects of other MRI parameters in its phase 2 trials, which were announced last summer. In addition, researchers were also able to trace a consistent safety profile. Receptos presented the findings at the largest meeting dedicated to MS to date, the joint meeting of the Americas Committee for Treatment and Research In Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS).
“Following our recent positive Phase 2 results in ulcerative colitis, we also plan to initiate a Phase 3 program for RPC1063 in inflammatory bowel disease in 2015. We believe that this drug candidate represents a potential franchise in immunology, and we continue to explore opportunities in other therapeutic indications where there is strong scientific rationale,” added the president and CEO of Receptos.
After having announced that they were looking for RMS patients for the SUNBEAM and RADIANCE trials at the end of last year, the company is also going to assess the RPC1063 therapy in inflammatory bowel disease (IBD) patients in its TOUCHSTONE phase 3 trial, which includes patients who suffer from UC, and a phase 2 trial in patients with Crohn’s disease. Both of the trials are scheduled to begin this year, and are based on the encouraging results obtained by the company in its prior studies of the medication with IBD.