Celgene’s big hope ozanimod lowers pMS score in long-term ulcerative colitis

After its $7.2 billion buyout of Receptos, Celgene ($CELG) has posted some encouraging midstage data for its acquired asset ozanimod for certain forms of inflammatory bowel disease.

In data posted this morning, the company showed updated parts from its Phase II Touchstone study of nearly several hundred ulcerative colitis (UC) patients.

These data came from across three treatment arms in those that entered the open-label extension of the trial if they did not respond to treatment after the induction phase, relapsed during the maintenance phase, or completed the maintenance phase (170 of the 197 patients).

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The point of this open-label extension phase was to look at how well the higher dose 1-mg form of the med might work long-term, and its safety profile.

During the extension period, Celgene said its med “resulted in a decrease in mean partial Mayo Score (pMS) in all treatment arms.” pMS is one way UC patients can have their disease measured during a trial.

For patients who had been treated with the lower dose ozanimod 0.5-mg during the double-blind portion of the study--and were then switched to the higher 1-mg dose--mean pMS score decreased from 4.5 at entry into the extension period, to 1.7 after 44 weeks.

And for patients who had been treated with ozanimod 1-mg initially, and then stayed on it for the extension phase of the study, mean pMS score decreased from 3.3 at entry into the extension period to 1.9, again after 44 weeks.

Lastly, for those on a dummy pill who were switched to ozanimod 1-mg for the extension phase of the study, mean pMS score decreased from 4.6 to 1.7 at week 44.

Celgene also said its data from the extension phase “showed a decrease in the proportion of patients with rectal bleeding and moderate or severe diarrhea.”

A year ago, the Big Biotech released data from the 103 patient-strong study in UC with its candidate, which showed they had achieved a clinical response after 8 weeks of therapy continued treatment for an added 24 weeks, and 21% in the 1-mg drug arm achieved or maintain remission at 32 weeks--compared to 6% in the placebo arm.

Celgene acquired ozanimod in its $7.2 billion Receptos buyout--with its Phase III program expected to read out in 2017, setting up what Celgene hopes will be an approval for a drug that could earn up to $6 billion a year, albeit in a busy UC space, and the growing threat of biosimilars.

Celgene also believes ozanimod will be the first S1P treatment approved for inflammatory bowel disease. The drug has also been in testing for certain forms of MS.

“Since ulcerative colitis is a chronic condition, patients are looking for treatments that can help them over the long term,” said Dr. William Sandborn, Professor of Medicine and Chief, Division of Gastroenterology and Director, University of California San Diego Inflammatory Bowel Disease Center.

“These encouraging findings suggest that continued treatment with ozanimod shows evidence of durable efficacy with an acceptable safety profile.”

“Findings from this extension study at week 44 showed improvements in efficacy measures for patients who took ozanimod throughout both the blinded study and the extension,” added Scott Smith, president of Celgene’s inflammation and immunology unit.