Pfizer Discontinues Once-Daily Weight Loss Pill Over Liver Injury In One Patient

Pfizer Inc. is discontinuing development of an oral glucagon-like peptide-1 (GLP-1) receptor agonist being investigated for chronic weight management.

Pfizer’s dose-optimization studies of once-daily formulations of danuglipron (PF-06882961) met key pharmacokinetic objectives. The study confirmed a formulation and dose that could deliver a competitive efficacy and tolerability profile in Phase 3 testing based on earlier studies of twice-daily danuglipron.

The stopped trials include:

• Phase 1, open-label study to evaluate the multiple-dose pharmacokinetics of danuglipron following oral administration in otherwise healthy adult participants with overweight or obesity.
• A two-part phase 1, open-label, fixed-sequence study to evaluate the multiple-dose pharmacokinetics of danuglipron following oral administration and the effects of steady-state danuglipron on the pharmacokinetics of single oral dose of atorvastatin and rosuvastatin in otherwise healthy adult participants with overweight or obesity.

Also Read: Benzinga Bulls And Bears: Apple, Nike, US Steel — And The Markets Ride Out Ongoing Volatility

The company said that while the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron is in line with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury, which resolved after discontinuation of danuglipron.

After reviewing the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer ( PFE ) has decided to discontinue development of the molecule.

Data from the danuglipron clinical development program will be presented at a scientific forum or submitted for publication in a peer-reviewed journal in the future.

In December 2023, Pfizer ( PFE ) reported topline data from the Phase 2b trial of danuglipron.

The company said the study met its primary endpoint, demonstrating a statistically significant change in body weight from baseline, but danuglipron was tied to "high rates" of mild gastrointestinal side effects, leading to more than half of the patients across all dose groups dropping out from the trial. 

Then, Pfizer ( PFE ) said the future development of danuglipron will be focused on a once-daily formulation and that it will stop evaluating a twice-daily formulation.

In July 2024, Pfizer ( PFE ) selected its preferred once-daily modified-release formulation for danuglipron.

Goldman Sachs noted that it is unlikely to obtain significant tolerability data that could address the main criticisms of the company's Phase 2b BID (twice daily) study.

The analyst said, "Further to debates that investors have been contemplating relating to "pill burden" — PFE expects that the study would involve and ultimately advance a single pill QD dose format — which, assuming positive results overall, would be the objective in terms of presentation to advance into a Phase 3 registrational study."

"This underpins the company's decision for further development and commitment to their goal of seeking a relevant and competitive presence in the oral obesity therapeutics market."

Price Action: Pfizer ( PFE ) is up 0.71% at $22.06 during the session at the last check Monday.

Read Next:

• FDA Approves Argenx’s Vyvgart Hytrulo Prefilled Syringe For Self-Injection For At Home Use Setting

Image: Shutterstock