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Pfizer on Tuesday said its experimental anti-obesity drug, which it acquired through Metsera, drove robust weight loss when taken once a month in a mid-stage trial.
“The data is very good and we are saying one thing clearly: We have a monthly product that has a very competitive profile in tolerability and efficacy,” Pfizer CEO Albert Bourla told CNBC on Tuesday.
Obese or overweight patients lost up to 12.3% of their weight compared to placebo at week 28 in the ongoing phase two study. Injection weight loss was up to 10.5% when analyzing all patients, regardless of discontinuations.
The company said no plateau was observed after patients moved to monthly dosing, suggesting continued weight loss is expected as the study continues through week 64.
The data offers preliminary evidence that the shot can be given less frequently than existing drugs without sacrificing effectiveness, which could be a big boost for Pfizer after it faced several setbacks in developing anti-obesity drugs. You are trying to enter a market dominated by Eli Lilly and Nordiskweekly Novo injections, with a strong new entrant in the Novo daily pill.
While it's unclear how much Pfizer could cut into its market share once the shot is available, monthly dosing could offer a more convenient option for patients.
Pfizer executives told CNBC that patients already using injectable GLP-1 medications are unlikely to switch to daily oral treatments, arguing that those patients would be more comfortable opting for less frequent injections to maintain weight loss.
Dr. Jim List, Pfizer's head of internal medicine, told CNBC that “the week doesn't work for everyone,” as some patients need to travel and can't keep their shots refrigerated.
Pfizer's shot “will help expand the market, help democratize weight loss, which is what we need, as well as allow patients to have a maintenance option that is more convenient for many of them,” List said. But he added that Pfizer's philosophy is that patients will benefit from having several different offerings in the obesity drug market, whether weekly or monthly injections or oral options.
Pfizer plans to advance 10 phase three trials of the shot, called PF'3944, this year. During Pfizer's earnings call later on Tuesday, the company's chief scientific officer, Chris Boshoff, said modeling predicts that a higher monthly dose of the shot Pfizer plans to use in the late-stage trial could result in a 16% weight loss by week 28.
Bourla told CNBC that the highest dose of the drug will produce efficacy and tolerability data that are “perhaps best in class, so it's better than anything else.”
Pfizer announced the results on the same day it posted fourth-quarter earnings and revenue that beat expectations. Pfizer shares closed nearly 3% lower on Tuesday.
The company's injection is an ultra-long-acting GLP-1 drug, meaning it is designed to remain active in the body longer than existing treatments like Wegovy de Novo. Pfizer is developing it as a weekly and monthly injection, as well as in combination with other treatments targeting different gut hormones.
In the trial, patients started with weekly injections of the drug for 12 weeks before switching to a monthly dose.
The study was designed to test whether different doses of the drug could help patients continue losing weight after switching from weekly to monthly injections. It also examined whether higher doses of the drug could be given monthly while still being tolerable for patients.
Patients generally tolerated the drug well and most gastrointestinal side effects were mild or moderate. This is consistent with other GLP-1 drugs.
Pfizer said there were no new safety concerns.
The company said it had selected two dosing regimens (a low and a medium monthly maintenance dose) to test in phase three trials. In the two dosing regimens of the phase two trial, five patients discontinued treatment due to side effects during the weekly phase of the trial, while another five discontinued the drug during the monthly phase.
In a separate mid-stage trial last year, Metsera said the highest dose of the shot demonstrated weight loss of up to 14.1% on average after 28 weekly doses.
