Pfizer pulls the plug on twice-daily obesity pill as study disappoints

By Manas Mishra and Michael Erman

(Reuters) -Pfizer said on Friday it would not advance a twice-daily version of oral weight-loss drug danuglipron into late-stage studies after most patients dropped out of an earlier trial with high rates of side effects such as nausea and vomiting.

Although Pfizer has a once-daily version of the weight-loss pill in the works, the decision still marks a blow to its ambition of entering a booming market that analysts expect to be worth $100 billion by the end of the decade.

Pfizer said the drug cut weight by as much as 13% at 32 weeks in adults with obesity and without type 2 diabetes in a mid-stage trial. That compares with 15% for Eli Lilly’s experimental oral drug at 36 weeks at a high dose.

Cantor Fitzgerald analyst Louise Chen found danuglipron results disappointing.

Aside from the side effects, the weight-loss results were below Wall Street’s expectations and lower than what doctors said would convince patients to switch over from injections, Chen said in a client note.

Shares of the drugmaker fell 4.8% to $29.33 in premarket trading.

Danuglipron belongs to the same class of diabetes and obesity treatments as Novo Nordisk’s Wegovy and Ozempic, and Eli Lilly’s Mounjaro and Zepbound.

Approved treatments in that class are currently injected, though Novo and Lilly are also testing oral versions of their drugs.

Pfizer said it would now focus on a once-daily, modified release version of danuglipron and that it was “gathering the data to understand its potential profile.” Data on how this version interacts with the human body is expected in the first half of next year.

Pfizer said while the common side effects in the twice-daily version study were mild, it saw high rates of those events in the trial. High discontinuation rates, greater than 50%, were seen across all doses, compared with about 40% with placebo.

It said that up to 73% of patients in the trial had nausea; up to 47% vomiting and up to 25% diarrhea. However, no new safety signals were observed in the study, Pfizer added.

BMO analyst Evan Seigerman said he was uncertain if a new version of the drug would overcome the challenged side-effect profile, adding that it was possible that the high vomiting rates could have contributed to the overall weight loss.

Danuglipron is among the most high-profile medicines in Pfizer’s drug development pipeline as the company works to replace lost revenue from slumping demand for its COVID-19 vaccine and treatment.

Pfizer has high hopes for the products, with CEO Albert Bourla saying an obesity pill could eventually be a $10-billion-a-year product for the drugmaker.

Pfizer shares are down more than 40% this year, due in part to falling sales of its COVID-19 products and investor concerns about potential competition for several of its top-selling drugs.

The drugmaker announced a $3.5 billion cost-cutting program in October, but is yet to disclose many specific details on the planned cuts.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New York; Editing by Shinjini Ganguli and Anil D’Silva)