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, CA, USA I April 1, 2015 I Receptos, Inc. (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(R)) in 1,200 patients with RMS. The primary objectives of the RADIANCE and SUNBEAM trials are to assess whether ozanimod is superior to Avonex(R) 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(R)) 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.
SOURCE: Receptos
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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, CA, USA I April 1, 2015 I Receptos, Inc. (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(R)) in 1,200 patients with RMS. The primary objectives of the RADIANCE and SUNBEAM trials are to assess whether ozanimod is superior to Avonex(R) 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(R)) 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.
SOURCE: Receptos
Post Views: 25
