LONDON, Oct 20 (APM) - Celgene is terminating development of mongersen in Crohn's disease and is awaiting Phase II results for the experimental drug in ulcerative colitis to decide if it has a future in that indication, the company has announced.
The New Jersey-based pharma said in a late Thursday statement that the GED-0301 (mongersen) Phase III REVOLVE trial (CD-002) in Crohn's disease (CD) and the extension trial (SUSTAIN, CD-004) will end.
Celgene has decided to stop the trials following a recent recommendation from the data monitoring committee, which assessed overall benefit/risk during a recent interim futility analysis. The analysis identified no meaningful safety imbalances.
In addition, the Phase III DEFINE trial (CD-003) in Crohn's disease will not begin. Celgene is waiting to review the full dataset from the Phase II trial with GED-0301 in ulcerative colitis (UC) to determine whether it will continue in that indication.
Paid $710 million upfront in 2014
Chief operating officer Scott Smith said: "Crohn's disease is a debilitating condition with few effective long-term treatment options. While we are disappointed with the results of REVOLVE, we remain committed to advancing our portfolio of novel medicines for patients suffering from this disease and other inflammatory bowel disorders."Celgene bought the rights to the experimental, orally-administered drug from Ireland's Nogra Pharma in April 2014 for $710 million upfront. (APMMA 38147)
Aggregate payments for regulatory and development milestones could potentially be $815 million for multiple indications, Celgene said then.
Inflammatory disease portfolio - ozanimod
Celgene said that at the World Congress of Gastroenterology meeting this month, two-year data from the Phase II TOUCHSTONE trial of ozanimod in UC and Phase II data from the STEPSTONE trial in CD were presented.The Phase III TRUENORTH pivotal trial of ozanimod in UC is ongoing. Celgene said it expects to start a Phase III pivotal trial in CD in the next few months.
Celgene said in May it expected to file ozanimod for relapsing multiple sclerosis in the U.S. later this year following a second successful Phase III trial (APMMA 53189). It is not yet approved in any indication.
Otezla in UC
It also singled out Otezla (apremilast). It said a randomised controlled Phase II trial (UC-001) in UC is ongoing, with data expected by the end of the year. Pending positive results, a broad Phase III UC programme could begin in 2018.Otezla is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
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