Celgene’s New Crohn’s Disease Drug Impressing Analysts
October 21, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Celgene 's new drug for the treatment of Crohn’s disease continues to impress analysts who are predicting major expansion into the market for the company, said Citigroup on Tuesday.
Biotech analyst Yaron Werber reported in a note from investors that data presented at this week’s United European Gastroenterology conference in Vienna has shown positive results for the Phase II trials of the drug.
“In our view the today’s full Phase II GED-0301 data suggest that GED-0301 may have meaningful efficacy/safety profile compared to biologics in Crohn’s disease,” Werber wrote. “Novel therapies with different modes of action are needed for Crohn’s disease to minimize steroids while inducing remission and based on the Phase II data GED-0301 meets these criteria and we remain optimistic on the future prospects of the drug.”
Werber added that Citi continues to view Celgene as poised for multiple expansion given the deep pipeline and the stock “remains one of our top picks.”
The note also highlighted that given that the goal of Crohn’s disease treatment is clinical remission, based on Phase II data, GED-0301 has higher remission rates at four weeks compared to anti-tumour necrosis factors. At the 40mg and 160mg doses, GED-0301 had remission rates of 55 percent and 65 percent at four weeks compared to 18-35 percent remission rates for anti-TNFs.
“In terms of safety, the drug appears well tolerated after today’s more detailed data and the rate of SAEs was low and balanced between arms,” said Werber. “Importantly, fibrosis has not been observed in humans or preclinical models with higher dosing. In addition, as the drug is dosed in intervals potential adverse events may be able to be mitigated by dose interruption.”
Citi said that Celgene is on track to initiate a Phase III Crohn’s study in December 2014.
“Based on the Phase II data Celgene believes they will be able to dose for 3-6 months in the study,” said Werber. “The Phase III study will be an induction regimen followed by a two-arm maintenance phase with two doses. Celgene also plans to use endoscopy which will allow a definitive diagnosis of Crohn’s disease.”