Pfizer Halts Another Oral Small-Molecule GLP-1 Drug Due to Safety Concerns
Pfizer
Pharmaceutical R&D Developer
At the end of 2022, the market values of Pfizer and Eli Lilly were still at the same level. In the blink of an eye, the market value of Eli Lilly has become 3.4 times that of Pfizer. Even Novo Nordisk, whose market value has long been smaller than Pfizer by one level, now has a market value 2.74 times that of Pfizer.
This significant change in market value is undoubtedly driven by the core variable of differences in the layout of GLP-1 class drugs.
It is no exaggeration to say that whoever has GLP-1 will rule the world.
Faced with the rapid advances of Eli Lilly and Novo Nordisk, it is impossible for Pfizer not to feel anxious. However, as the saying goes, "Misfortunes never come singly." On December 1, 2023, Pfizer announced the failure of another small-molecule GLP-1 oral drug, marking the second such setback for the company in just half a year.Small molecule GLP-1 oral drug.
On December 1, Pfizer stated to the public that the experimental weight-loss drug danuglipron (an oral GLP-1 medication taken twice daily) would not proceed to Phase III trials due to a higher frequency of observed adverse reactions.
Previously, Pfizer had released the results of the Phase 2b clinical trial for danuglipron.
Trial results showed that in patients with type 2 diabetes, danuglipron significantly reduced glycated hemoglobin (HbA1c), fasting blood glucose levels, and body weight. In patients receiving the highest dose of danuglipron, HbA1c decreased by 1.16 percentage points and body weight decreased by 4.17 kilograms.
The failure of danuglipron this time was mainly due to safety reasons.
Clinical trial data show that up to 73% of patients experienced nausea, up to 47% experienced vomiting, and up to 25% experienced diarrhea. The discontinuation rate was high across all doses.
From the statistical data of clinical trials, a relatively high discontinuation rate generally indicates that the drug has significant side effects, preventing patients from continuing its use.
In June this year, Pfizer also abandoned another small-molecule GLP-1 class drug for safety reasons.Development of Lotiglipron.
Lotiglipron is a drug developed by Pfizer for obesity and diabetes, which patients only need to take orally once a day. However, during the mid-stage clinical trial phase, patients exhibited elevated transaminase levels, a phenomenon that usually indicates damage to hepatocytes and liver function.
In giving upFollowing the continued development of danuglipron, PfizerThe only oral GLP-1 drug still in development is PF-07081532.PF-07081532With a longer half-life, it supports once-daily oral administration, butPF-07081532 is an optimization based on danuglipron, and its final safety still needs to be proven by data.
At this point, Pfizer, which has fallen far behind in injectable GLP-1 drugs, has also largely lost hope of catching up with Eli Lilly in oral formulations.
Of course, the above judgment is only based on the self-developed pipeline, and it does not rule out the possibility that Pfizer may achieve a leapfrogging advancement through acquisitions.
Previously, AstraZeneca, which had also encountered consecutive failures with GLP-1, opted for the introduction route,Finally, a $2 billion exclusive partnership was reached with China's Biotech company Eternity Bio for the oral small molecule GLP-1 drug ECC5004.
Currently, there are approximately 19 small-molecule GLP1R candidates globally in clinical trials. The fastest-progressing is Eli Lilly's Orforglipron, which has advanced to Phase 3, followed by Pfizer, Hanmi, Hengrui, and Huadong Medicine in Phase 2.
ECC5004, an oral small-molecule GLP-1 drug developed by Chime Biologics, is currently in Phase I clinical trials in the United States involving healthy volunteers and patients with type 2 diabetes.
So, will Pfizer, in the same situation, also choose to come to China to "seek treasures"?
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