Manufacturing Pfizer to Stop Development of Oral Obesity Drug Amidst...

Pfizer to Stop Development of Oral Obesity Drug Amidst Liver Safety Concerns

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Pfizer is set to discontinue one of its oral obesity drugs – namely lotiglipron –  after observing higher levels of liver enzymes in clinical studies. Because of this setback, the short-term hopes of Big Pharma are dependent on a candidate that is administered twice as frequently as the competing weight reduction drugs being developed by Novo Nordisk and Eli Lilly.

Last year, Pfizer provided midphase information on its GLP-1 receptor agonist danuglipron. The findings showed that the oral obesity medicine is effective in terms of weight reduction, but in order for it to have the most impact, it had to be administered twice daily at the maximum dose possible. According to the latest data, the rates of gastrointestinal side effects as well as discontinuations due to complications climbed as the dose increased.

Pfizer delayed making a decision about whether or not to begin a phase 3 study of danuglipron until it received a closer look at its other GLP-1 receptor agonist, lotiglipron. This was due to the fact that Lilly and Novo were pushing once-daily medicines. Lotiglipron, if administered once daily, may have been able to address the shortcomings of danuglipron and posed a greater threat to both Lilly and Novo. 

However, Pfizer disclosed on Monday that lotiglipron has its own set of challenges to overcome. The company decided to suspend the clinical trial process of the obesity candidate after conducting an analysis of the data from a couple of phase 1 drug-drug interaction trials as well as a phase 2 study. Pfizer explained its choice by citing pharmacokinetic data as well as higher transaminases, a kind of enzyme that might point towards liver dysfunction.

There were no reports of liver-related complaints or adverse effects from any of the patients, neither was there any indication that the liver was deteriorating. Pfizer attempted to put some space between the findings of danuglipron and those regarding lotiglipron by pointing out that no transaminase increases were observed in clinical studies that recruited more than 1,400 individuals.

Even so, Pfizer has suffered a setback with the cancellation of lotiglipron development. Lotiglipron gave Pfizer the opportunity to match the dose schedule of Lilly’s orforglipron and Novo’s oral semaglutide. Orforglipron caused a weight reduction of 14.7% after 36 weeks. The substance developed by Novo has its own set of convenience issues because it is a medication that must be administered on an empty stomach with a sip of water. However, it must be noted that out of the three candidates, danuglipron is the only one that may be taken twice daily.

Pfizer is aware that its competitors are gaining an edge in terms of convenience, and as a result, the company has decided to focus on developing a once-daily modified-release form of danuglipron while simultaneously progressing the existing formulation into a pivotal study. The Big Pharma anticipates that it will be able to complete a late-phase program for the present formulation by the close of the year, but the ultimate decision on whether or not to move forward will rely on the results from phase 2b.

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