SUNBEAM Phase 3 Trial of Ozanimod in Relapsing Multiple Sclerosis Continues to Enroll According to Plan; Overall Phase 3 Program on Track to be Completed in 1H 2017
Receptos Well Capitalized to Advance Clinical Development Programs
SAN DIEGO, April 1, 2015 (GLOBE NEWSWIRE) -- Receptos, Inc. (Nasdaq:RCPT) announced today that the Company has completed enrollment in the RADIANCE Phase 3 trial of ozanimod (formerly RPC1063) in patients with Relapsing Multiple Sclerosis (RMS). The trial was over-enrolled by approximately 10% due to strong interest among investigators and patients. The Company is continuing to enroll the SUNBEAM trial of ozanimod in patients with RMS. Receptos is on track to complete this Phase 3 clinical development program in the first half of 2017.
"Completing enrollment of the RADIANCE trial represents another major corporate milestone for Receptos, and positions ozanimod as the potential next-to-market oral agent for the treatment of relapsing multiple sclerosis," said Faheem Hasnain, President and Chief Executive Officer of Receptos. "Following positive Phase 2 results in ulcerative colitis, we also plan to initiate a Phase 3 program for ozanimod in inflammatory bowel disease in 2015. We believe that ozanimod represents a potential franchise in immunology, and we continue to explore opportunities in other therapeutic indications where there is strong scientific rationale."
The announcement follows the disclosure in September 2014 of the detailed Phase 2 results of ozanimod in RMS. In that trial, ozanimod met the primary endpoint of reduction in MRI brain lesion activity as well as secondary endpoints measuring effects on other MRI parameters. The overall safety profile of ozanimod was consistent with the results of prior trials and continues to be differentiated from other oral agents for the treatment of RMS.
The RADIANCE and SUNBEAM Phase 3 trials each are randomized, double-blind studies designed to compare 0.5 mg and 1.0 mg of ozanimod against interferon beta-1a (Avonex®) in 1,200 patients with RMS. The primary objectives of the RADIANCE and SUNBEAM trials are to assess whether ozanimod is superior to Avonex® in reducing the annualized relapse rate in patients after two years of therapy and one year of therapy, respectively. Both trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA.
Receptos had $671.9 million in cash, cash equivalents and short term investments as of December 31, 2014, leaving it well capitalized to continue advancing its clinical development programs.
About Ozanimod
Ozanimod (formerly RPC1063) is a novel, oral, once daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator in development for autoimmune indications including relapsing multiple sclerosis (RMS) and ulcerative colitis (UC). In a Phase 2 trial in patients with RMS, ozanimod achieved the primary endpoint of reduction in MRI brain lesion activity as well as secondary endpoints measuring effects on other MRI parameters. The overall safety profile of ozanimod was consistent with the results of prior trials and continues to demonstrate differentiation against other oral agents for treatment of RMS. Receptos is now conducting a Phase 3 clinical development program comprised of two trials: RADIANCE and SUNBEAM, both of which are randomized, double-blind studies designed to compare 0.5 mg and 1.0 mg of ozanimod against interferon beta-1a (Avonex®) in patients with RMS.
Ozanimod is also being studied in inflammatory bowel disease (IBD). The TOUCHSTONE Phase 2 trial of ozanimod in UC met its primary endpoint and all secondary endpoints with statistical significance in patients on the 1.0 mg dose of ozanimod in the 8-week induction period. The overall safety and tolerability profile of ozanimod was consistent with the results of the recent Phase 2 trial in RMS, and continues to support the potential for orally administered ozanimod to significantly improve the treatment paradigm for UC patients. The maintenance period of the TOUCHSTONE trial is currently ongoing. Receptos plans to initiate a Phase 3 program in UC and a Phase 2 program in Crohn's disease in 2015.
About Receptos
Receptos is a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases. The Company's lead program, ozanimod, is a sphingosine 1-phosphate 1 and 5 receptor small molecule modulator in development for immune indications including RMS and IBD. Patents supporting ozanimod were exclusively licensed to Receptos from The Scripps Research Institute (TSRI). The Company is also developing RPC4046, an anti-interleukin-13 (IL-13) antibody for eosinophilic esophagitis (EoE), an allergic/immune-mediated orphan disease.
Forward-Looking Statements
Statements contained in this release, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "anticipates," "may," "intends," "plans," "potential" and similar expressions are intended to identify forward-looking statements. Investors are cautioned that these forward-looking statements are not guarantees of future performance. Forward-looking statements, include without limitation, statements regarding the sufficiency of the Company's capital to fund its future operations, the ability of the Company to successfully undertake certain development activities (such as clinical trial enrollment and the conduct of clinical trials) and accomplish certain development goals (such as the completion of clinical trials and availability of clinical trial results), and the safety, efficacy, projected development timeline and therapeutic and commercial potential for ozanimod, RPC4046 and the GLP-1 positive allosteric modulator program. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks regarding the Company's financial position and research and development programs are described in detail in the Company's SEC filings, including the Company's Annual Report on Form 10-K for the year ended December 31, 2014. All forward-looking statements contained in this release speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.