— Pivotal Phase 3 Trial is Underway with First Patients Randomized in December 2013 —
— Topline Results of Phase 2 Still Expected in Mid-2014 —
SAN DIEGO, CA, USA I January 6, 2014 I Receptos, Inc. announced today that the Company has enrolled the first patients in the Phase 3 portion of RADIANCE, its Phase 2/3 study of RPC1063 in relapsing multiple sclerosis (RMS). The announcement follows the review of interim analysis of the Phase 2 portion of the study which was announced in December 2013.
The RADIANCE Phase 2/3 study was designed to accelerate the RMS clinical development program for RPC1063 by allowing advancement into Phase 3 in a rapid fashion and eliminating the delay that typically exists between the completion of a Phase 2 study and the initiation of a subsequent Phase 3 study. Many of the clinical trial sites involved in the Phase 2 portion of the study are also participating in the Phase 3 portion of the study, allowing for efficient enrollment of Phase 3 patients that are separate from the Phase 2 patient population. In addition, Receptos has obtained Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration on the clinical trial design for both the Phase 3 portion of RADIANCE as well as a second planned RMS Phase 3 study. The second Phase 3 study is planned to begin after announcement of the top-line results of the Phase 2 portion of the RADIANCE study, which is expected to occur in mid-2014.
“Our initiation of Phase 3 positions RPC1063 as the potential next-to-market sphingosine 1-phosphate 1 receptor (S1P1R) modulator for the treatment of relapsing multiple sclerosis,” said Faheem Hasnain, President and Chief Executive Officer of Receptos. “Since the founding of Receptos in 2009, we have made rapid progress in the development of RPC1063, which we believe may represent a best-in-class molecule in the S1P1R modulator class. In addition to the top-line results of the Phase 2 portion of RADIANCE, we also look forward in mid-2014 to the top-line results of TOUCHSTONE, our Phase 2 study of RPC1063 in ulcerative colitis, as well as continued progress with our pipeline programs.”
About RPC1063
RPC1063 is a novel, oral, once daily, selective and potent sphingosine 1-phosphate 1 receptor (S1P1R) modulator in development for autoimmune indications. The Phase 2 portion of the RADIANCE study is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of RPC1063 against placebo in patients with RMS. While the Phase 2 study was originally designed to enroll 210 patients, the trial over enrolled a total of 258 patients and completed enrollment on time in October 2013. The Phase 3 portion of the trial is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of RPC1063 against interferon beta-1a (Avonex(R)) in 1,200 patients with RMS. Receptos is also enrolling a randomized Phase 2 study, called TOUCHSTONE, examining the efficacy, safety and tolerability of RPC1063 in ulcerative colitis (UC). Top-line results for both studies are expected in mid-2014.
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 receptor (S1P1R) small molecule modulator candidate for immune indications, including relapsing multiple sclerosis (RMS) and inflammatory bowel disease (IBD). The Company is also developing RPC4046, an anti-interleukin-13 (IL-13) antibody for an allergic/immune-mediated orphan disease, eosinophilic esophagitis (EoE). Receptos has established expertise in high resolution protein crystal structure determination, biology and drug discovery for G-protein-coupled receptors (GPCRs).
SOURCE: Receptos
Post Views: 84
— Pivotal Phase 3 Trial is Underway with First Patients Randomized in December 2013 —
— Topline Results of Phase 2 Still Expected in Mid-2014 —
SAN DIEGO, CA, USA I January 6, 2014 I Receptos, Inc. announced today that the Company has enrolled the first patients in the Phase 3 portion of RADIANCE, its Phase 2/3 study of RPC1063 in relapsing multiple sclerosis (RMS). The announcement follows the review of interim analysis of the Phase 2 portion of the study which was announced in December 2013.
The RADIANCE Phase 2/3 study was designed to accelerate the RMS clinical development program for RPC1063 by allowing advancement into Phase 3 in a rapid fashion and eliminating the delay that typically exists between the completion of a Phase 2 study and the initiation of a subsequent Phase 3 study. Many of the clinical trial sites involved in the Phase 2 portion of the study are also participating in the Phase 3 portion of the study, allowing for efficient enrollment of Phase 3 patients that are separate from the Phase 2 patient population. In addition, Receptos has obtained Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration on the clinical trial design for both the Phase 3 portion of RADIANCE as well as a second planned RMS Phase 3 study. The second Phase 3 study is planned to begin after announcement of the top-line results of the Phase 2 portion of the RADIANCE study, which is expected to occur in mid-2014.
“Our initiation of Phase 3 positions RPC1063 as the potential next-to-market sphingosine 1-phosphate 1 receptor (S1P1R) modulator for the treatment of relapsing multiple sclerosis,” said Faheem Hasnain, President and Chief Executive Officer of Receptos. “Since the founding of Receptos in 2009, we have made rapid progress in the development of RPC1063, which we believe may represent a best-in-class molecule in the S1P1R modulator class. In addition to the top-line results of the Phase 2 portion of RADIANCE, we also look forward in mid-2014 to the top-line results of TOUCHSTONE, our Phase 2 study of RPC1063 in ulcerative colitis, as well as continued progress with our pipeline programs.”
About RPC1063
RPC1063 is a novel, oral, once daily, selective and potent sphingosine 1-phosphate 1 receptor (S1P1R) modulator in development for autoimmune indications. The Phase 2 portion of the RADIANCE study is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of RPC1063 against placebo in patients with RMS. While the Phase 2 study was originally designed to enroll 210 patients, the trial over enrolled a total of 258 patients and completed enrollment on time in October 2013. The Phase 3 portion of the trial is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of RPC1063 against interferon beta-1a (Avonex(R)) in 1,200 patients with RMS. Receptos is also enrolling a randomized Phase 2 study, called TOUCHSTONE, examining the efficacy, safety and tolerability of RPC1063 in ulcerative colitis (UC). Top-line results for both studies are expected in mid-2014.
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 receptor (S1P1R) small molecule modulator candidate for immune indications, including relapsing multiple sclerosis (RMS) and inflammatory bowel disease (IBD). The Company is also developing RPC4046, an anti-interleukin-13 (IL-13) antibody for an allergic/immune-mediated orphan disease, eosinophilic esophagitis (EoE). Receptos has established expertise in high resolution protein crystal structure determination, biology and drug discovery for G-protein-coupled receptors (GPCRs).
SOURCE: Receptos
Post Views: 84
