Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at how liver safety concerns have halted the development of Pfizer’s lead obesity asset, Merck’s deal with Cyprumed to leverage its oral peptide platform, the success of Lilly’s oral GLP-1 receptor in a phase 3 trial, and other top news! Stay informed and inspired by the innovations driving life sciences forward!
Pfizer Ends Development of Danuglipron Following Liver Safety Concerns
Pfizer has ceased development of its oral GLP-1 drug danuglipron due to a potential case of drug-induced liver injury observed during dose-optimization trials. The affected patient showed no symptoms, and the condition resolved after discontinuation. Despite liver enzyme levels being comparable to similar drugs, Pfizer opted to stop development after regulatory discussions. Danuglipron had shown high adverse event rates, including nausea (73%), vomiting (47%), and over 50% discontinuation across doses. Following a prior formulation setback, the drug was reintroduced as a once-daily pill but was now abandoned. Pfizer’s remaining obesity candidate is PF-07976016, currently in Phase II trials.
Merck Licenses Cyprumed’s Oral Peptide Delivery Platform in $493 Million Deal
Merck & Co. has entered a licensing agreement with Austria-based Cyprumed, potentially worth up to $493 million, to access Cyprumed’s oral peptide delivery platform for an undisclosed number of drug targets. The nonexclusive deal includes upfront and milestone-based payments tied to development, regulatory, and commercial progress. Merck may secure exclusive rights to specific targets later. The company will oversee all R&D and commercialization efforts. Cyprumed’s technology enhances peptide oral bioavailability using approved excipients. This agreement follows Merck’s earlier peptide-related deals, including with Unnatural Products and ongoing development of MK-0616 and efinopegdutide in its peptide pipeline.
Eli Lilly’s Orforglipron Shows Comparable Results to Semaglutide in Phase 3 Trial
Eli Lilly’s oral GLP-1 receptor agonist orforglipron met its primary efficacy endpoint in a Phase 3 trial, showing A1C reductions of 1.3% to 1.6% over 40 weeks in people with Type 2 diabetes, compared to 0.1% with placebo. Weight loss ranged from 4.7% to 7.9%, with the highest dose group averaging a 7.3 kg reduction. Reported adverse events included diarrhea (up to 26%), nausea (18%), and indigestion (20%). The results are part of a larger clinical program, with additional Type 2 diabetes and obesity trials ongoing. Lilly plans to seek approval for obesity in 2025 and Type 2 diabetes approval in 2026.
Vanda Sues FDA Over Restrictions on Off-Label Drug Promotion
Vanda Pharmaceuticals has filed a lawsuit against the U.S. FDA, alleging that the agency’s restrictions on off-label drug communication violate First Amendment rights. Filed on April 9 in the Southern District of Texas, the lawsuit centers on Vanda’s desire to share clinical data supporting the use of Hetlioz, approved for non-24-hour sleep-wake disorder and Smith-Magenis syndrome, for jet lag, an unapproved indication. Vanda argues that FDA policies deter the dissemination of accurate, non-promotional information. This legal action follows prior disputes, including the FDA’s rejections of Hetlioz for jet lag in 2019 and tradipitant for gastroparesis in 2024.
Johnson & Johnson MedTech Begins First Human Trial of Ottava Surgical Robot
Johnson & Johnson MedTech has completed the first clinical use of its Ottava surgical robot during a minimally invasive Roux-en-Y gastric bypass procedure at Memorial Hermann-Texas Medical Center. The system, which received FDA approval in fall 2023 to begin human trials, is intended for laparoscopic, open, and hybrid soft tissue surgeries. Initially slated for a 2022 debut, development was delayed by pandemic-related disruptions. Successful trial completion may lead to FDA de novo clearance for multiple upper abdominal procedures. Ottava integrates robotic arms with a movable patient table and is compatible only with instruments from J&J’s Ethicon division.
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