Pfizer on Friday stated it could cease creating the twice-daily model of its experimental weight loss pill after overweight sufferers taking the drug misplaced weight however had hassle tolerating the drug in a mid-stage clinical study.
The drugmaker noticed excessive charges of antagonistic uncomfortable side effects, which have been principally delicate and gastrointestinal, amongst sufferers. A major share of sufferers additionally stopped taking the drug within the trial.
“At this time, twice-daily danuglipron formulation will not advance into Phase 3 studies,” the corporate stated.
However Pfizer stated it nonetheless plans to launch section two trial information on a once-a-day model of the drug within the first half of 2024, which can “inform a path forward.” The pharmaceutical big will wait to see that information earlier than deciding whether or not to begin a section three research on the once-daily capsule, which Wall Avenue views because the extra aggressive type of the therapy.
Nonetheless, the info on the twice-daily drug is a blow to Pfizer’s hopes to win a $10 billion slice of the booming weight reduction drug market, which CEO Albert Bourla has stated might develop to $90 billion. The corporate is betting on a profitable weight reduction capsule to assist it rebound from plummeting demand for its Covid products and a roughly 40% share value drop this 12 months.
However traders have been pessimistic about Pfizer’s potential within the weight reduction drug area for the reason that firm scrapped a special once-daily capsule in June and proceeded with the much less engaging danuglipron. Now, Friday’s information places Pfizer even additional behind the dominant gamers within the weight reduction drug market, Eli Lilly and Novo Nordisk, that are racing to develop more convenient pill versions of their blockbuster weight reduction and diabetes injections.
Pfizer’s phase two trial on its twice-daily capsule adopted round 600 overweight adults who didn’t have Sort 2 diabetes. The trial examined the drug’s impact on weight reduction after 26 or 32 weeks, at completely different dosage quantities starting from 40 milligrams to 200 milligrams.
Like Novo Nordisk’s Wegovy and Ozempic, Pfizer’s capsule works by mimicking a hormone produced within the intestine known as GLP-1, which indicators to the mind when an individual is full.
All dose sizes of Pfizer’s capsule confirmed “statistically significant reductions” in physique weight starting from 6.9% to 11.7% at 32 weeks, and from 4.8% to 9.4% at 26 weeks. In the meantime, sufferers on a placebo misplaced 8% to 13% of their physique weight at 32 weeks and 5% to 9.5% at 26 weeks, Pfizer stated.
The corporate stated excessive charges of antagonistic occasions have been noticed amongst sufferers within the research, with as much as 73% experiencing nausea, as much as 47% vomiting and as much as 25% experiencing diarrhea. Discontinuation charges amongst sufferers have been better than 50% throughout all dose sizes in comparison with roughly 40% amongst those that took the placebo, based on Pfizer.
No new questions of safety have been noticed, and danuglipron was not related to elevated liver enzymes like Pfizer’s different discontinued weight reduction capsule.
Knowledge from the section two trial shall be offered at a future scientific convention or revealed in a peer-reviewed journal.
The tolerability points align with some analysts’ predictions forward of the info launch.
Leerink Companions analyst David Risinger wrote in a Monday word that the proportion of sufferers who discontinue therapy with Pfizer’s twice-daily danuglipron within the section two trial would seemingly be larger than those that stopped taking a once-daily capsule from Eli Lilly.
By comparability, 10% to 21% of sufferers who took Eli Lilly’s capsule, orforglipron, in a mid-stage trial discontinued the therapy at 32 weeks as a result of antagonistic uncomfortable side effects, he famous.
Risinger stated that is seemingly as a result of danuglipron’s whole day by day dose is much larger, which can trigger extra antagonistic results. Pfizer’s phase-two trial additionally did not enable downtitration, or reducing the dose of a drug over time as soon as a particular response has been achieved. Eli Lilly’s mid-stage trial on its capsule did.
There may be hope that sufferers will higher tolerate the once-daily model of danuglipron in comparison with the twice-daily type. Pfizer seems to consider a once-daily model of the drug might reduce gastrointestinal uncomfortable side effects, based on some analysts.
They pointed to Pfizer’s second-quarter earnings name, when the corporate’s chief scientific officer, Mikael Dolsten, suggested {that a} once-daily model could enhance a affected person’s tolerability of the drug, which might reduce the gastrointestinal uncomfortable side effects “that have been seen as limiting” danuglipron.
However the results shall be unclear till the mid-stage trial information is launched subsequent 12 months.
Greater than 2 in 5 adults have weight problems, based on the National Institutes of Health. About 1 in 11 adults have extreme weight problems.
