Roche shared additional Phase 1b data for the obesity drug it acquired in the Carmot Therapeutics deal that suggest a higher dose had yet to peak at six months.
An abstract, which is set to be presented in September at the European Association for the Study of Diabetes annual meeting in Madrid, showed that the GLP-1/GIP agonist had not plateaued in weight reduction at the 24-week mark, meaning the 18.8% reduction could be higher than that.
The time-plotted trajectory disclosed Monday bodes well for the 22 mg dose of the once-weekly injectable as Roche looks to catch up to other obesity drugmakers.
Jefferies analysts said CT-388 “looks competitive,” citing the still-sloping pace of weight loss and no tolerability issues. Every patient given 22 mg of the drug reported at least a 5% reduction in weight at the 24-week mark and 45% reported at least a 20% reduction.
Manu ChakravarthyManu Chakravarthy, Roche’s SVP and global head of cardiovascular, renal and metabolism product development, said Monday in an interview that the company plans to launch a Phase 2 study later this year. The trial is expected to assess weight loss in addition to other outcomes like improvements in cardiovascular disease and type 2 diabetes.
“We’re also going to utilize the Phase 2 to further fine-tune dose regimens,” Chakravarthy said.
Patients given CT-388 began at 5 mg, with one arm working up to 8 mg and another up-dosing to 22 mg. There have been no reported treatment-related discontinuations in the study. More data from an even higher dose of 24 mg are expected later this year.
Jefferies maintains a $4 billion peak sales projection, which estimates a 2029 launch and significant investments in a Phase 3 study.
Teresa GrahamRoche’s pharma chief Teresa Graham told investors in April that the company “looked at a fully burdened cost structure” for all of its recent deals, including Carmot, which it acquired last year for $2.7 billion. She suggested that future commercial efforts could do more with less, saying that there’s “no appetite” from providers for “the kind of commercialization footprint that most pharma has been operating with over time.”
“I do just want to sort of reiterate that we know that commercialization in these areas begins now, and that is something that we are fully prepared to do,” Graham said.