Receptos Begins RMS Patient Enrollment in SUNBEAM and RADIANCE Trials

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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RMS clinical study

ReceptosBiopharmaceutical company Receptos, Inc. is enrolling the first patient in theirĀ SUNBEAM phase 3 trial to evaluateĀ the company’s investigational therapy for the treatment ofĀ patients with relapsing multiple sclerosis (RMS) and ulcerative colitis (UC), calledĀ RPC1063. In addition, Receptos has recently started its phase 3Ā RADIANCE trial, also with RMS patients. Both of the trials are currently enrolling patients, and the company expects to complete the programs in 2017.

TheĀ novel oral, once daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator RPC1063 is being developed by Receptos for the treatment of autoimmune diseases, such as RMS. It has been demonstrated effective in the decrease ofĀ MRI brain lesion activity, the primary endpoint of its phase 2 trial, as well as in secondary endpoints measuring effects on other MRI parameters. In addition, the company has verifiedĀ RPC1063’s safety profile and consistency with prior results and other oral agents for treatment of RMS.

Receptos is currently assessing the therapy in two randomized, double-blind trials,Ā RADIANCE and SUNBEAM, which are included in the company’s phase 3 clinical development program. Within both studies,Ā 0.5 mg and 1.0 mg of RPC1063 will be compared withĀ interferon beta-1a (Avonex) in RMS patients. “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.

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“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,”Ā Hasnain added. The launchĀ of the two new trialsĀ comes afterĀ the release of the company’sĀ phase 2 trial findings this past September, spurring onĀ further studies to advance the therapy’s development for RMS.

RADIANCE and SUNBEAM will together enroll 1,200 RMS patients in order to evaluateĀ RPC1063’s superiority toĀ Avonex in the decrease of theĀ annualized relapse rate in patients who have beenĀ treated for eitherĀ two years orĀ one year, respectively. The two phase 3 trials are going to be completed under the Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

Receptos has presented the findings of theĀ phase 2 portion of theĀ RADIANCE, at aĀ 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)Ā —Ā theĀ largest meeting dedicated to multiple sclerosis to date. Last November, the companyĀ has also completed an underwritten public offering of common stock that enabled it to raise $414 million in gross proceeds, which were added to the company’sĀ balance of cash,Ā cash equivalents and short-term investments for aĀ total of $302.9 million.

In addition, the company is evaluating the use ofĀ RPC1063 as a treatment forĀ inflammatory bowel disease (IBD) in theĀ TOUCHSTONE phase 3 trial in patients with UC, and aĀ phase 2 trial in patients with Crohn’s disease, both of which are planned for 2015,Ā after the encouraging results obtained by the company inĀ its prior studies of the medication with IBD.