Roche offered a glimpse at promising early efficacy data on Thursday morning from a GLP-1/GIP agonist it obtained as part of its $2.7 billion acquisition of Carmot Therapeutics.
In a Phase 1 trial testing CT-388, participants saw a mean placebo-adjusted weight loss of 18.8% at 24 weeks (p<0.001). All subjects hit more than 5% weight loss and almost half (45%) had more than 20% weight loss, according to a company release.
The study is enrolling 96 overweight or obese adults who are otherwise healthy as well as obese adults with type 2 diabetes. Roche’s share price $ROG.SW crept up 3% to around CHF 234 on Thursday.
While it’s challenging to compare data across trials, CT-388’s Phase 1 data are not dissimilar to Boehringer Ingelheim and Zealand Pharma’s survodutide, which achieved almost 19% weight loss at 48 weeks in a Phase 2 test. In a Phase 1 study of Amgen’s MariTide, patients lost an average of 14.5% of their body weight over 85 days.
Meanwhile, less than 40% of patients in the registrational study for Novo Nordisk’s Wegovy achieved more than 20% weight loss, but almost 60% did with Eli Lilly’s Zepbound.
Before the Roche-Carmot deal was announced in December, the biotech touted proof-of-concept data from a separate Phase 1/2 CT-388 trial. Roche’s acquisition was completed a month after the announcement, when the companies said CT-388 was Phase 2-ready.
In the Phase 1 trial, the Swiss pharma said that CT-388 was linked with mild to moderate gastrointestinal side effects. The candidate normalized blood sugar levels in a subset of prediabetic participants at baseline, an effect that’s consistent with its broader drug class.
Jefferies analysts said the data were “encouraging” but added that “questions remain given the highly competitive market before commercial potential can be assessed.” In particular, the analysts said they wanted more details on the dose titration used, the specific dose cohort the results came from, and rates of treatment discontinuation.
There is extraordinary demand for Novo Nordisk’s GLP-1 and Eli Lilly’s GLP-1/GIP drugs, with both companies grappling with shortages. Other companies such as Amgen and Boehringer Ingelheim/Zealand are looking to differentiate their incretin candidates by either increasing the duration of weight loss or addressing broader cardiometabolic diseases that accompany obesity.
Roche said in December it saw a “large opportunity” to combine its acquired weight loss drugs with its own candidates, including a myostatin drug that could help preserve muscle mass. Loss of muscle is a key concern among marketed GLP-1s.
The Jefferies analysts said CT-388 could reach $4 billion in peak sales with the caveat of high costs for Phase 3 development and the likely need for “future commercial investment.”
Editor’s note: This article was updated to add context to Amgen’s data.