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Pfizer PFE announced that it has selected its preferred once-daily modified-release formulation of danuglipron, its oral GLP-1 receptor agonist, for further development as a weight loss pill based on encouraging results from an ongoing study. It evaluated several formulations of danuglipron and said that one showed “the most favorable profile.” Pfizer, however, did not announce any detailed clinical data from the study.

In the second half of the year, Pfizer will conduct dose optimization studies on multiple doses of the preferred modified-release formulation to select the optimal dose to move forward to pivotal studies.

Previously, Pfizer faced setbacks related to its pipeline candidates for obesity. In December last year, Pfizer announced that it would not move forward with phase III studies on the twice-daily formulation of danuglipron. Though the candidate was effective in reducing weight in a phase IIb study, it caused several gastrointestinal side effects like nausea, vomiting and diarrhea. Back then, the company said that the pharmacokinetic study of the once-daily formulation of danuglipron continues and it will focus on its development. In June 2023, Pfizer dropped the development of another GLP-1-RA candidate, lotiglipron, due to elevated levels of a type of liver enzymes seen in a study.

Along with the latest release, Pfizer said that data from studies on the once-daily formulations have shown a similar safety profile to the twice-daily formulation. However, treatment with danuglipron did not lead to any increased incidence of liver enzyme elevation in more than 1,400 study participants.

Pfizer said it has three clinical and several pre-clinical candidates in its pipeline for obesity, with danuglipron being the most advanced.

Pfizer’s shares were up slightly more than 1% as its announcement to move forward with the development of the once-daily weight loss pill marks its comeback to the obesity space.

Year to date, the stock has declined 0.5% against the industry’s 23.3% rise.

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Obesity has become a global health problem as it can cause other diseases like heart disease, diabetes and stroke, leading to an exponential increase in demand for obesity medicines. Also, social media has somewhat hyped the benefits of these medications.

The GLP-1 segment is an important class of drugs for multiple cardiometabolic diseases and is gaining significant popularity. GLP-1 drugs work by mimicking the hormone GLP-1, resulting in weight loss, lowering hemoglobin A1c (HbA1c) and reducing cardiovascular risks.

The obesity market is dominated by Novo Nordisk’s NVO Wegovy and Eli Lilly’s LLY Zepbound. Both Wegovy and Zepbound are also GLP-1 receptor agonists but are injectable treatments, unlike danuglipron, which is an oral treatment. Both Wegovy and Zepbound have seen exceptional demand growth.

Novo Nordisk is also evaluating a once-daily oral formulation of Wegovy in late-stage studies. Lilly also has a once-daily oral nonpeptide GLP-1 receptor agonist called orforglipron in its pipeline, which is in late-stage development. Oral pills as weight loss drugs, if approved, can significantly improve patients’ convenience and potentially their costs.

Viking Therapeutics (VKTK) is also progressing with the development of its GIP/GLP-1 agonist called VK2735 for obesity. VK2735 has shown impressive weight loss reductions in studies for both the subcutaneous (phase II) and novel oral (phase I) formulations. Viking Therapeutics plans to advance both formulations into further development later this year.

Amgen AMGN also has a GLP-1 receptor candidate, MariTide (maridebart cafraglutide), for obesity in its pipeline. In May, Amgen said it was “very encouraged” with the interim data from the phase II study on MariTide. Top-line 52-week data from the phase II study is expected in late 2024. Amgen is planning to conduct a comprehensive phase III program on the candidate across obesity, obesity-related conditions and diabetes.

Zacks Rank

Currently, Pfizer has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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