Pfizer Discontinues As soon as-Every day Weight Loss Capsule Over Liver Damage In One Affected person – Pfizer (NYSE:PFE)

Pfizer Inc. PFE is discontinuing improvement of an oral glucagon-like peptide-1 (GLP-1) receptor agonist being investigated for power weight administration.

Pfizer’s dose-optimization research of once-daily formulations of danuglipron (PF-06882961) met key pharmacokinetic targets. The examine confirmed a formulation and dose that might ship a aggressive efficacy and tolerability profile in Section 3 testing based mostly on earlier research of twice-daily danuglipron.

The stopped trials embody:

• Section 1, open-label study to judge the multiple-dose pharmacokinetics of danuglipron following oral administration in in any other case wholesome grownup members with obese or weight problems.
• A two-part part 1, open-label, fixed-sequence study to judge the multiple-dose pharmacokinetics of danuglipron following oral administration and the consequences of steady-state danuglipron on the pharmacokinetics of single oral dose of atorvastatin and rosuvastatin in in any other case wholesome grownup members with obese or weight problems.

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The corporate stated that whereas the general frequency of liver enzyme elevations throughout the over 1,400 participant security database of danuglipron is according to accredited brokers within the class, a single asymptomatic participant in one of many dose-optimization research skilled potential drug-induced liver damage, which resolved after discontinuation of danuglipron.

After reviewing the totality of knowledge, together with all medical information generated so far for danuglipron and up to date enter from regulators, Pfizer has determined to discontinue improvement of the molecule.

Knowledge from the danuglipron medical improvement program will probably be introduced at a scientific discussion board or submitted for publication in a peer-reviewed journal sooner or later.

In December 2023, Pfizer reported topline information from the Section 2b trial of danuglipron.

The corporate stated the examine met its major endpoint, demonstrating a statistically important change in physique weight from baseline, however danuglipron was tied to “excessive charges” of delicate gastrointestinal unwanted effects, resulting in greater than half of the sufferers throughout all dose teams dropping out from the trial. 

Then, Pfizer stated the long run improvement of danuglipron will probably be centered on a once-daily formulation and that it’s going to cease evaluating a twice-daily formulation.

In July 2024, Pfizer chosen its most popular once-daily modified-release formulation for danuglipron.

Goldman Sachs famous that it’s unlikely to acquire important tolerability information that might tackle the primary criticisms of the corporate’s Section 2b BID (twice every day) examine.

The analyst stated, “Additional to debates that buyers have been considering referring to “tablet burden” — PFE expects that the examine would contain and finally advance a single tablet QD dose format — which, assuming constructive outcomes general, could be the target by way of presentation to advance right into a Section 3 registrational examine.”

“This underpins the corporate’s resolution for additional improvement and dedication to their objective of in search of a related and aggressive presence within the oral weight problems therapeutics market.”

Value Motion: Pfizer is up 0.71% at $22.06 through the session on the final test Monday.

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