Pfizer announced on Friday that it would discontinue development of the twice-daily version of its experimental weight reduction pill after obese patients in a mid-stage clinical research lost significant weight but had difficulty digesting the treatment.
- IMPORTANT NOTES
- Pfizer announced that it would discontinue development of the twice-daily version of its experimental weight reduction pill after obese individuals in a mid-stage clinical research lost weight but had difficulty digesting the treatment.
- However, the pharmaceutical giant stated that it still intends to reveal phase two trial data on danuglipron, a once-daily version of the medicine, in the first half of 2024.
- The new data is a setback for Pfizer’s goal of capturing a $10 billion slice of the burgeoning weight loss medicine industry, which CEO Albert Bourla previously predicted might expand to $90 billion.
Patients experienced a high proportion of unfavorable side effects, which were primarily mild and gastrointestinal, according to the pharmaceutical. A considerable number of patients also stopped using the medication.
“At this time, the twice-daily danuglipron formulation will not advance into Phase 3 studies,” a statement from the business stated.
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Pfizer, on the other hand, stated that it still intends to release phase two trial findings on a once-daily version of the medicine in the first half of 2024, which will “inform a path forward.” The pharmaceutical behemoth will await the results of that research before choosing whether to begin a phase three study on the once-daily pill, which Wall Street sees as the most competitive form of the medication. Shares of Pfizer fell 4% in premarket trading Friday after it announced the trial results.
Nonetheless, the results on the twice-daily medicine are a setback for Pfizer’s goal of capturing a $10 billion share of the burgeoning weight loss treatment industry, which CEO Albert Bourla has predicted could expand to $90 billion. The business is banking on a blockbuster weight reduction tablet to help it recover from low demand for its COVID medicines and a 40% decline in share price this year.
However, investors have been skeptical of Pfizer’s prospects in the weight loss medicine area since the company abandoned a different once-daily pill in June in favor of the less appealing danuglipron. Now, Pfizer has fallen even further behind the market’s major rivals, Eli Lilly and Novo Nordisk, which are racing to develop more convenient tablet versions of their blockbuster weight loss and diabetic injections.
Pfizer’s phase two trial of its twice-daily tablet included 600 obese people without type 2 diabetes. The study looked at the drug’s effect on weight loss after 26 or 32 weeks at various dosage levels ranging from 40 milligrams to 200 milligrams. Pfizer’s tablets, like Novo Nordisk’s Wegovy and Ozempic, operate by imitating GLP-1, a hormone generated in the gut that signals to the brain when a person is full.
Pfizer stated that the Danuglipron trial met the primary goal of establishing “statistically significant” weight loss. Patients who took the pill twice a day lost an average of 6.9% to 11.7% of their body weight after 32 weeks and 4.8% to 9.4% after 26 weeks. In the meantime, placebo participants gained 1.4% of their body weight at 32 weeks and 0.17% at 26 weeks.
After controlling for the difference in weight gain observed in individuals who received the placebo, Pfizer’s twice-daily pill resulted in an average weight loss of 8% to 13% at 32 weeks and 5% to 9.5% at 26 weeks. According to the business, patients in the research experienced a significant proportion of adverse effects, with up to 73% feeling nausea, 47% vomiting, and 25% having diarrhea. According to Pfizer, more than 50% of patients across all dose sizes quit taking the pill, compared to around 40% of those on the placebo.
There were no new safety concerns discovered, and danuglipron was not linked to elevated liver enzymes like Pfizer’s other withdrawn weight loss drug. The results of the phase two trial will be presented at a future scientific meeting or published in a peer-reviewed publication.
Pfizer’s hopes from Wall Street
The tolerability difficulties are consistent with projections made by certain experts ahead of the data release. In a Monday note, Leerink Partners analyst David Risinger predicted that the proportion of patients who quit taking Pfizer’s twice-daily danuglipron would be higher than the proportion who stopped taking Eli Lilly’s once-daily medication. In a mid-stage experiment, 10% to 21% of patients who took Eli Lilly’s tablet, orforglipron, terminated the treatment after 32 weeks due to serious side effects, he said.
Risinger believes this is because the overall daily dose of danuglipron is much higher, perhaps causing more unwanted effects. Patients on Pfizer’s maximum dose size took 400 milligrams per day, while those on Eli Lilly’s highest dosage took 45 milligrams per day.
Pfizer’s phase-two trial also did not allow for downtitration, or gradually decreasing a drug’s dose after achieving a specified response. Eli Lilly’s mid-stage tablet study did. There is hope that patients will tolerate the once-daily danuglipron better than the twice-daily variant. According to some experts, Pfizer appears to assume that a once-daily version of the medicine could reduce gastrointestinal side effects.
They cited Pfizer’s second-quarter earnings call, during which the company’s chief scientific officer, Mikael Dolsten, suggested that a once-daily version of danuglipron may improve a patient’s tolerability of the drug, potentially reducing the gastrointestinal side effects “that have been seen as limiting” danuglipron. However, the consequences will not be known until the mid-stage study data is disclosed next year. Notably, the weight loss caused by danuglipron twice daily looked to fall short of experts’ estimates.
Several analysts predicted that Pfizer’s twice-daily pill would have to be roughly as effective as Eli Lilly’s once-daily pill to be competitive. Cantor Fitzgerald analyst Louise Chen told me earlier this month that this equates to a 14% to 15% weight loss.
Risinger also stated in October that Pfizer’s Danuglipron must show weight loss in the “mid-teens” percentages in order to compete with Eli Lilly’s drug. According to the results of the company’s phase-two research, obese or overweight patients who took 45 milligrams of Eli Lilly’s pill once a day lost up to 14.7% of their body weight, or 34 pounds, after 36 weeks.
The results from Eli Lilly appear to be congruent with the weight loss generated by a high-dose oral form of Novo Nordisk’s semaglutide, the active ingredient in the diabetes medicine Ozempic and the weight loss treatment Wegovy, but were obtained over a shorter trial period.According to the National Institutes of Health, more than one in every five Americans is obese. One in every eleven adults is severely obese.
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