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pfizer The company announced Thursday that its experimental obesity drug, acquired through Metsala, produced solid weight loss when taken once a month in a mid-term trial.
In an ongoing Phase 2 trial, obese or overweight patients lost up to 12.3% of their body weight compared to placebo at 28 weeks. Regardless of discontinuation, weight loss with injections was up to 10.5% when all patients were analyzed.
The company said no plateau was observed after patients transitioned to monthly dosing, suggesting continued weight loss is expected as the study continues through week 64.
The data provides early evidence that the shot can be injected less frequently than existing drugs without sacrificing efficacy, and could be a big boost for Pfizer, which has faced several setbacks in developing obesity drugs. trying to enter a market dominated by Eli Lilly and novo nordiskweekly injections, a powerful new entrant to Novo’s daily pills.
It’s unclear how much market share Pfizer will be able to reduce once a vaccine becomes available, but monthly dosing could be a more convenient option for patients.
“These top-line results…reinforce the potential of PF’3944 as a monthly therapy with competitive efficacy,” Dr. Jim List, Pfizer’s chief internal medicine officer, said in the release.
Pfizer plans to move forward with 10 Phase 3 trials of the shot, called PF’3944, this year. In remarks prepared for Pfizer’s earnings call later Tuesday, the company’s chief scientific officer, Chris Boshoff, said modeling predicts that increasing the monthly dose of the shot Pfizer plans to use in late-stage trials could result in a 16% weight loss at week 28.
Pfizer announced its financial results on the same day, announcing fourth-quarter profit and sales that exceeded expectations. Pfizer stock fell nearly 3% in premarket trading Tuesday.
The company’s injectables are ultra-long-acting GLP-1 drugs, designed to remain active in the body longer than existing treatments such as Novo’s Wigovy. Pfizer is developing the drug as weekly and monthly injections and in combination with other treatments that target different gut hormones.
In this trial, patients began weekly injections of the drug for 12 weeks, then switched to monthly dosing.
The study was designed to test whether different doses of the drug helped patients continue to lose weight after switching from weekly to monthly injections. We also investigated whether higher doses of the drug could be given monthly while still being tolerated by patients.
The drug is generally well tolerated by patients, with most gastrointestinal side effects reported to be mild or moderate. This is consistent with other GLP-1 drugs.
Pfizer said there were no new safety issues.
The company announced that it has selected two dosing regimens, a low and medium monthly maintenance dose, to be tested in a Phase 3 study. Across the two dosing regimens in the Phase 2 study, five patients discontinued treatment due to side effects during the weekly phase of the study, and another five discontinued the drug during the monthly phase.
Another mid-term study conducted last year demonstrated an average weight loss of up to 14.1% with the highest-dose injections after 28 weekly doses, Metsala said.
