– Following Positive Phase 2 Results, Receptos Now Enrolling Two Phase 3 Trials in Relapsing Multiple Sclerosis –
– Receptos Well Capitalized to Advance Clinical Development Program –
SAN DIEGO, Dec. 22, 2014 (GLOBE NEWSWIRE) -- Receptos, Inc. (Nasdaq:RCPT) announced today that the Company has enrolled the first patient in the SUNBEAM Phase 3 trial of RPC1063 in patients with relapsing multiple sclerosis (RMS). The Company had previously initiated the Phase 3 portion of the RADIANCE trial in patients with RMS. With both trials now actively enrolling patients, Receptos is on track to complete this Phase 3 clinical development program in 2017.
"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 Faheem Hasnain, President and Chief Executive Officer of Receptos. "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."
The announcement follows the disclosure in September 2014 of the detailed Phase 2 results of RPC1063 in RMS. In that trial, RPC1063 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 RPC1063 was consistent with the results of prior trials and continues to be differentiated on this basis from other oral agents for treatment of RMS.
As with the RADIANCE trial, the SUNBEAM trial is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of RPC1063 against interferon beta-1a (Avonex®) in 1,200 patients with RMS. The primary objective for the RADIANCE and SUNBEAM trials is to assess whether RPC1063 is superior to Avonex® in reducing the annualized relapse rate in patients after two years of therapy and one year of therapy, respectively. Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreement with the FDA.
In November 2014, Receptos completed an underwritten public offering of common stock raising $414 million in gross proceeds. This adds to the Company's significant balance of cash, cash equivalents and short-term investments, which totaled $302.9 million as of September 30, 2014.
About RPC1063
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, RPC1063 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 RPC1063 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 RPC1063 against interferon beta-1a (Avonex®) in patients with RMS.
RPC1063 is also being studied in inflammatory bowel disease (IBD). The TOUCHSTONE Phase 2 trial of RPC1063 in UC met its primary endpoint and all secondary endpoints with statistical significance in patients on the 1 mg dose of RPC1063 in the 8-week induction period. The overall safety and tolerability profile of RPC1063 was consistent with the results of the recent Phase 2 trial in RMS, and continues to support the potential for orally administered RPC1063 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, RPC1063, is a sphingosine 1-phosphate 1 and 5 receptor small molecule modulator in development for immune indications including RMS and IBD. Patents supporting RPC1063 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 RPC1063, RPC 4046 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, 2013 and subsequent Quarterly Reports on Form 10-Q. 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.