Thursday, Pfizer Inc (NYSE:PFE) announced it selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist.
Pfizer plans to conduct dose optimization studies in the second half of 2024, evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.
In this PK study design, Goldman Sachs notes that it is unlikely to obtain significant tolerability data that could address the main criticisms of the company's Phase 2b BID study. The earlier study had high rates of GI-related adverse events (mostly mild) and a high discontinuation rate, which disappointed both the firm and investors.
From an efficacy perspective, the Phase 2b BID study showed a weight loss of up to 11.7% at 32 weeks. This falls within the 9-14% range that investors would find competitive. For comparison, Eli Lilly And Co's (NYSE:LLY) orforglipron achieved approximately 13% weight loss at 26 weeks.
Several other companies are progressing through clinical trials with oral therapeutics, and upcoming data updates will continually influence expectations for Pfizer's potential opportunities.
However, due to the minimal data disclosed, Goldman Sachs analysts that there isn't enough information to accurately reassess the company's competitive standing.
Based on data from over 1,400 patients, Pfizer noted a reassuring safety profile for danuglipron and plans to integrate key insights from the prior Phase 2b study. This supports their decision to continue development and underscores their commitment to establishing a competitive presence in the oral obesity therapeutics market.
The analyst says, "Further to debates that investors have been contemplating relating to "pill burden" – PFE expects that the study would involve and ultimately advance a single pill QD dose format – which, assuming positive results overall, would be the objective in terms of presentation to advance into a Phase 3 registrational study."
"This underpins the company's decision for further development and commitment to their goal of seeking a relevant and competitive presence in the oral obesity therapeutics market."
The analyst is Buy rated on PFE shares with a price target of $31.
Price Action: PFE shares are up 1.26% at $29.02 at last check Friday.
Photo via Shutterstock