Biotech is bouncing back from the FTC news that raised concerns over M&A activity (read details here). Today, weight loss names are in the spotlight and adding hype to the gigantic market opportunity. Pfizer had data published on its oral GLP-1 weight loss drug in the medical journal JAMA. Although this data was not new, headlines made comparisons to Novo’s blockbuster weight loss drug Ozempic. Novo also announced topline data for their oral version of Ozempic, which was comparable to the injectable already being used for weight loss.
Interest in Orals > Current Sub-Cutaneous Injectables
Pfizer is developing two oral GLP-1 agonists:
- danuglipron is a twice-daily oral GLP-1
- PF-07081532 is a once daily oral GLP-1
Pfizer plans to advance one of the two candidates to Phase 3, based on efficacy, tolerability and dosing. Today, danuglipron had Phase 2 data in type 2 diabetes patients peer reviewed in medical journal JAMA Network.
80-mg (-2.04kg) and 120-mg (-4.17kg) of danuglipron demonstrated a reduction in body weight that was statistically significantly at week 16 compared with placebo.
As a percentage of body weight, the 80-mg and 120-mg of twice-daily oral danuglipron resulted in 2.7% and 5% of body weight loss at 16 weeks, respectively. For comparison’s sake, Novo’s injectable semaglutide reported 3.9% weight loss at 12 weeks for patients with type 2 diabetes. This bodes well for Pfizer’s danuglipron which has comparable results to Novo’s blockbuster semaglutide.
Why Is Pfizer’s Data Significant?
In addition to being an oral alternative to the current market leading sub-q options, Pfizer’s danuglipron could yield even better data in obese patients without type 2 diabetes.
Generally, patients with type 2 diabetes lose less weight compared to those without type 2 diabetes. A possible explanation could be a greater decrease in energy expenditure among patients with type 2 diabetes compared with those without type 2 diabetes. In addition, weight loss results in an improvement of glucose control, leading to a decrease in glycosuria. Consequently, this creates a positive calorie balance, making it more difficult to lose weight.
Pfizer’s once-daily oral PF-07081532 has also shown weight reduction up to 6 weeks. Although this once-daily pill has limited data, there is clear signs of activity. Pfizer will have two seemingly strong candidates to choose from to take into Phase 3 obesity studies.
Novo’s Oral Semaglutide Reported Phase 3 Topline Comparable to Sub-Q
Novo once-daily oral 50mg semaglutide reported 15.1% bodyweight reduction at 68-weeks vs placebo at 2.4%. This 12.7% placebo-adjusted weight reduction is in line with the sub-cutaneous version of semaglutide currently approved for weight loss which reported a 12.4% placebo-adjusted weight reduction at week 68.
Significance: Novo’s oral semaglutide is expected to be the first oral treatment in the market, years ahead of Pfizer’s treatment which has yet to enter Phase 3.
Other Notable Obesity Candidates
1. Novo’s CagriSema (once-weekly subcutaneous): CagriSema is a combination of semaglutide and a novel amylin analogue, cagrilintide. In Phase 2 overweight patients with diabetes, CagriSema achieved a body weight reduction of 15.6% after 32 weeks. CagriSema is currently in Phase 3 for obesity in a trial called REDEFINE3 where Novo expects 13-15% weight reduction in diabetic patients and 20% weight loss in non-diabetes obesity.
If actually achieved, this would put CagriSema’s results in line with leading Mounjaro and Wegovy and give Novo another hit in the obesity treatment.
2. Amgen’s AMG-133 (monthly sub-cutaneous injector): In Phase 1, AMG-133 showed a 14.5% reduction in body weight after 12 weeks in patients without type 2 diabetes. Amgen (AMGN) is currently engaged in Phase 2 that will also include patients with type 2 diabetes.
3. Smaller Players: Viking's VK2735 is expected to be a weekly sub-cutaneous injection that demonstrated a 7.8% reduction in body weight after 4 weeks. Viking is also testing a daily oral version of the drug. In the preclinical area, Terns Pharma (TERN) has an oral GLP-1 agonist called TERN-601 with plans to initiate Phase 1 in 2H 2023. Both companies are in early stages of development and will be beneficiaries of data that bigger names like Novo, Lilly and Pfizer release.
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