Biopharmaceutical company Receptos, Inc. is enrolling the first patient in their SUNBEAM phase 3 trial to evaluate the company’s investigational therapy for the treatment of patients with relapsing multiple sclerosis (RMS) and ulcerative colitis (UC), called RPC1063. In addition, Receptos has recently started its phase 3 RADIANCE trial, also with RMS patients. Both of the trials are currently enrolling patients, and the company expects to complete the programs in 2017.
The 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 of 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 verified 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, RADIANCE and SUNBEAM, which are included in the company’s phase 3 clinical development program. Within both studies, 0.5 mg and 1.0 mg of RPC1063 will be compared with 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.
“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,” Hasnain added. The launch of the two new trials comes after the release of the company’s phase 2 trial findings this past September, spurring on further studies to advance the therapy’s development for RMS.
RADIANCE and SUNBEAM will together enroll 1,200 RMS patients in order to evaluate RPC1063’s superiority to Avonex in the decrease of the annualized relapse rate in patients who have been treated for either two years or 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 the phase 2 portion of the RADIANCE, at a 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) — the largest meeting dedicated to multiple sclerosis to date. Last November, the company 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’s balance of cash, cash equivalents and short-term investments for a total of $302.9 million.
In addition, the company is evaluating the use of RPC1063 as a treatment for inflammatory bowel disease (IBD) in the TOUCHSTONE phase 3 trial in patients with UC, and a phase 2 trial in patients with Crohn’s disease, both of which are planned for 2015, after the encouraging results obtained by the company in its prior studies of the medication with IBD.