Roche Holding Ltd (RHHBY.US) announced that in a mid-stage trial, obese patients receiving its experimental injectable weight-loss drug CT-388 achieved an 18% greater weight reduction compared to those on a placebo. This positive clinical trial outcome will aid the Swiss pharmaceutical giant in competing within the lucrative weight-loss drug market.
CT-388 is a dual-agonist peptide targeting GLP-1R/GIPR, originally developed by Carmot Therapeutics. In December 2023, Roche announced a definitive agreement to acquire Carmot Therapeutics for $3.1 billion, thereby gaining ownership of CT-388. This acquisition also signified Roche's official return to the GLP-1 therapeutic area.
Roche had previously been developing the GLP-1 receptor agonist Taspoglutide, which entered Phase 2 clinical trials in 2008. However, by 2011, Roche discontinued development of this candidate drug due to its side effects.
CT-388 is a once-weekly subcutaneous GLP-1R/GIPR agonist being developed for the treatment of obesity and type 2 diabetes (T2D). The latest trial results from Roche show that at week 48, obese or overweight subjects treated with CT-388 (low, medium, and high doses, up to 24mg once weekly, subcutaneous) achieved a maximum weight reduction of 18.3% (adjusted for the placebo group).
Regarding safety, CT-388 was well-tolerated, with most gastrointestinal-related adverse events being mild to moderate in severity and consistent with the profile of incretin-based therapies. Furthermore, the rate of treatment discontinuation due to adverse events was low (5.9% in the CT-388 group versus 1.3% in the placebo group).
Roche stated it will initiate late-stage trials this quarter. The company ultimately plans to test it not only as a standalone therapy but also in combination with other weight-loss treatments.
Analyst Stefan Schneider from Swiss bank Vontobel noted that the mid-stage research data for Roche's weight-loss candidate CT-388 appears encouraging. The bank anticipates that Roche could launch the drug as early as 2028 and estimates its peak sales could reach 2.5 billion Swiss francs.
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