Pfizer is playing in the busy field of obesity medications, but he hoped to compete with a daily pill to the current GLP-1 products currently available. Instead, Pfizer is stopping the development of his medicine, Danuglipron, after a liver complication arose in a clinical trial.
The pharmaceutical giant was evaluating Danuglipron in two phase dose optimization studies. The company said Monday that a patient in one of those studies experienced a possible drug -induced liver lesion. This complication was resolved after the discontination of the study of the study.
Novo Nordisk, with his agonist LPG-1 Wegovy, and Eli Lilly, whose Zepbound drug activates the GLP-1 and GIP receptors, currently dominate the obesity medication market. But both products are administered as injections once in which they are fine. Pfizer is part of a growing rivals group with the aim of differentiating from market leaders with drugs formulated as daily pills.
Danuglipron, who was discovered internally inside Pfizer, is an oral molecule designed to join and activate the GLP-1 receiver. The drug was initially developed for a dose twice a day, and the results of the middle stage in 2023 showed a statistically significant weight loss. But many study participants also stopped taking the medication, which led Pfizer to abandon the plans to advance this formulation to phase 3. Pfizer focused on the development of a version once a day or Danuglipron.
High levels of liver enzymes are a potential sign of liver toxicity. Pfizer said that through more than 1,400 participants in the Danuglipron study, the general frequency of high liver enzymes is in line with the approved LPG-1 medications. But to be competitive in obesity, a medicine must match at least the safety profile of the medications currently available, and any sign of liver lesion is a red flag. At the end of last year, the high levels of liver enzymes obtained in phase 2 led biogeo laboratories to discontinue the development of the Azelaprag obesity drug candidate, which was testing in combination with Lilly’s Zepbound. Pfizer said he decided to suspend the development of Danuglipron after reviewing all the clinical data generated to date for the medication throughout the recent contributions of regulators.
Hepatic enzymes previously torted another Pfizer Oral GLP-1 medication. The pharmaceutical giant suspended the development of Lentiglipron in 2023 due to the high liver enzymes observed in phase tests 1. It was then that the company changed the approach to Danuglipron. Pfizer said that the most detailed data of the Danuglipron Clinical Development Program will be presented at a future scientific meeting or will be sent for publication in a peer reviewed magazine.
Pfizer still has other perspectives of obesity in its pipe. PF-07976016, an oral drug designed to activate the GIP receptor, is currently in phase tests 2. The Pfizer Pipeline lists another GLP-1 agonist, PF-0695-4522, which is found in phase 1 test for type 2 diabetes. But some analysts say that the reverse of Danuglipron can take Pfizer to look For your next metabolic medicine. William Blair analyst Andy Hsieh, says VK2735 of Viking Therapeutics, an agonist of the GLP-1 and GIP receptors, as a perspective.
A phase 3 of VI2735 injected subcutaneously is on the way to start phase 3 tests in the current quarter. A phase 2 test of an oral version of the Viking drug is in progress with the expected data in the third quarter of this year. In a research note, HSIH said the Viking medication “could offer Pfizer a rare opportunity to restore not only a mere presence in obesity, but also a leadership position” beyond Novo Nordisk and Lilly Drugs.
The readings of Readink, Thomas Smith, said the solid data of phase 1B of VK2735, presented the Conference of the Obesity Week last November. The reduction in body weight and low gastrointestinal side effects are compared favorable for competitors and reinforces the best potential of the medication, Smith said in a note sent to investors.
“In general, we believe that Danuglipron’s interruption further emphasizes the importance of efficacy and security in the competitive development panorama for obesity, and observes the convincing clinical profile until the date of both [subcutaneous] and VK2735 oral, “he said.
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