Receptos Launches SUNBEAM Phase 3 Trial for Relapsing Multiple Sclerosis Therapy

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by Patricia Silva, PhD |

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ReceptosBiopharmaceutical companyĀ Receptos, Inc. has enrolled the first participantĀ withĀ relapsing multiple sclerosis (RMS) in its SUNBEAM phase 3 trial, which will evaluate the potential therapyĀ RPC1063 in patients who suffer from the disease. The company’s phase 3 RADIANCE trial, also involvingĀ RMS patients, had already been initiated, which means that Receptos may be able to finish its clinical development program forĀ multiple sclerosis by 2017, according to the company’sĀ 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 areĀ randomized, double-blind studies that will include 1,200 RMS patients, and areĀ designedĀ to compareĀ 0.5 mg and 1.0 mg doses of RPC1063 withĀ interferon beta-1a (Avonex). In addition, the trials aim to evaluateĀ RPC1063’s superiority in comparison withĀ Avonex regarding the decrease of theĀ annualized relapse rate following either one orĀ two years of therapy.Ā Both of the phase 3 trials are taking place under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

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The RPC1063 therapy had already been demonstrated to be promising for treatment of MS, as it met theĀ primary endpoint of reduction in MRI brain lesion activity andĀ secondary endpoints measuring effects ofĀ other MRI parameters in its phase 2 trials, which were announcedĀ last summer. In addition, researchers were also able to trace a consistent safety profile. Receptos presented the findings atĀ theĀ largest meeting dedicated to MSĀ to date, theĀ joint meeting of the Americas Committee for Treatment and Research In Multiple Sclerosis (ACTRIMS) and the EuropeanĀ Committee for Treatment and Research In Multiple SclerosisĀ (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.Ā 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,” addedĀ the president and CEOĀ of Receptos.

After having announced that they were looking for RMS patients for the SUNBEAM and RADIANCE trials at the end of last year, theĀ company is also going to assessĀ the RPC1063 therapy inĀ inflammatory bowel disease (IBD) patients in its TOUCHSTONE phase 3 trial, which includes patients who suffer fromĀ UC, and aĀ phase 2 trial in patients with Crohnā€™s disease. Both of the trials are scheduled to begin this year, and are based onĀ the encouraging results obtained by the company inĀ its prior studies of the medication with IBD.