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Pfizer cans twice-daily oral obesity program after half of patients leave trial while once daily continues

2023-12-01

临床2期临床1期临床结果

A pharmacokinetic study of a once-daily formulation of danuglipron is continuing.

Pfizer is continuing to pinball between oral obesity asdanugliprons after making twice-daily danuglipron its top prospect, the Big Pharma has dropped the program after more than half of people taking the drug candidate dropped out of a midphase clinical trial.

Pfizeripron was cemented as Pfizer’s lead obesity asset in June after the company dropped itsdanuglipron GLP-1 receptor agonist, lotiglipron, in response to a liver safety concern. Focusing on danuglipron left Pfizer with a treatment that is given more frequently than rival molecules from Eli Lilly, Novo Nordisk and Structure Therapeutics but kept it toward the front of the race for the oral market.

DanuglipronPfizer revealed pPfizerb data tobesityught the curtain down on twice-daily danuglipron. The trGLP-1 receptor agonist GLP-1 receptorimary endplotiglipronparticipants experiencing placebo-adjusted weight reddanuglipronging fPfizer to 13% at 32 weeks, but the treatment proved intolerable for many people.Eli Lilly Novo Nordisk Structure Therapeutics

Pfizer repoPfizeriscontinuation rates in excess of 50% across all the studied danuglipdanuglipronAround 40% of subjects dropped out of the placebo cohort. Pfizer’s release lacks a detailed look at why patients left the study but the tolerability data on danuglipron offers a potential explanation. Up to 73% of people reported nausea. Rates of vomiting and diarrhea hit 47% and 25%, respectively.

Pfizerintestinal side effects are a problem for other GLP-1 receptor agonists danugliprones in Pfizer’s trial far exceed those reported in studies of the aPfizerd injectable medicines, Wegovy and Zepbound, that are sold by Novo Nordisk and Eli Lilly, resdanuglipron nausea vomiting diarrhea

Pfizer dropped plans to take the twice-daily formulatiGLP-1 receptorron into phase 3 in light oPfizerdata. A pharmacokinetic study of a once-daily formulation of danuglipron is continuiWegovy willZepboundthe next steps.Novo Nordisk Eli Lilly

Pfizerory, Pfizer could pivot to the once-daily formulation danuglipronaking stride. Talking to investors on a quarterly results conference call in October, Mikaedanuglipronchief scientific officer at Pfizer, said “it's within our reach, if we decide to start the pivotal study next year, to do it with a once-a-day molecule.” At that time, Dolsten said a data drop that could inform the decision was scheduled for early next year.

If the oncePfizer formulation has the same tolerability problems, Pfizer will lose ground on its rivals but retain a space in the oral GLP-1 race. Earlier this year, the Big Pharma began a phase 1 triaPfizernother GLP-1 asset, PF-06954522, that grew out of its work with Sosei Heptares. Discussing the asset, Dolsten told investors that Pfizer is “building a platform” around GLP-1 and has “a pretty strong effort here.”

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