Receptos to Begin Phase III Trials of an Investigational Medicine in Relapsing Multiple Sclerosis and Ulcerative Colitis

Receptos is set to start phase III trials of a sphingosine-1—phosphate-1–receptor modulator codenamed RPC1063. Trial investigators are recruiting participants.

With the start of 2014, Receptos is set to start the phase III portion of a combined phase II/III trial of RPC1063 in relapsing multiple sclerosis (RMS). Like Gilenya (fingolimod), the RPC1063 compound is a sphingosine-1—phosphate-1–receptor modulator. Receptos President and CEO Faheem Hasnain believes RPC1063 may be a best-in-class molecule.

The phase III trial of RPC1063 for RMS, known as RADIANCE, differs slightly from the usual procedure of investigation. The normally separate phase II and III trials have been streamlined into a single phase II/III trial. The double-blind, randomized, placebo-controlled trials will compare clinical results with use of RPC1063 with clinical results in patients receiving placebo or interferon beta-1a (Avonex).

In the RADIANCE trial, which is currently recruiting participants, investigators will measure the total number of new gadolinium-enhancing lesions on brain magnetic resonance imaging over a 24-week treatment period. Eligible participants include males and females between 18 and 55 years of age whose Expanded Disability Status Scale (EDSS) score must be no higher than 5 (the scale ranges from 0 to 10 points).

The 5-year-old company is expected to report initial results of RADIANCE around the middle of 2014, followed soon after by a second phase III trial, pursuant to a Special Protocol Assessment (SPA) agreement between Receptos and the FDA.

Receptos is also seeking an indication for RPC1063 in ulcerative colitis (UC) in the TOUCHSTONE phase II clinical trial. Results are expected by mid 2014. The 32-week, double-bind, placebo-controlled trial evaluates a low-dose version and a high-dose version of RPC1063 against placebo in inducing and sustaining remission of UC symptoms.

According to ClinicalTrials.gov, investigators expect to start analyzing final results by June or July 2014. To find out more about the trials, patients with UC or MS who are interested in enrolling can find relevant information by visiting ClinicalTrials.gov and searching for the studies by the designators NCT01647516 and NCT01628393.