Pfizer (NYSE:PFE) declined Monday following mixed data from its obesity program. In an announcement, Pfizer said it would continue development of its GLP-1-RA candidate danuglipron toward late-stage development for obesity and type 2 diabetes, but discontinue its second candidate, lotiglipron.
These medicines are intended to keep blood sugar at healthy levels and work by increasing the amount of insulin released and lowering the amount of glucagon released into the blood. They also slow down the digestion of food and increase the feeling of fullness after eating.
Pfizer said the decision to terminate the clinical development of lotiglipron was based on data from a Phase 1 study and laboratory measurements of elevated liver enzymes in these Phase 1 studies as well as the ongoing Phase 2 study. None of these participants reported liver-related symptoms or side effects, there was no evidence of liver failure, and none needed treatment.
Importantly, the same problems have not been observed in the over 1,400 patients enrolled in the danuglipron program, Pfizer said.
BMO analysts said today’s news highlights the benefit of the dual development path, as safety signals are not uncommon in early clinical development programs.
“Following today's decision, we look to 4Q23 phase 2b readouts for danuglipron in non-diabetic, obese patients as the next key catalysts for the program. We're also focused on the finalized trial design for the asset, in addition to formulation work progress,” they said.
The BMO analysts added, “We emphasize that the dual development program allows Pfizer to remain competitive, despite the lotiglipron setback, given the progress of danuglipron. We believe this remains a meaningful opportunity for Pfizer as we model $5.7B peak unadjusted revenue ($2.7B adjusted) across PFE's GLP-1 franchise.”
Shares of Pfizer were down over 5% following the update.