Regeneron's Obesity Trial With Novo Nordisk's Wegovy Hits Lean Target

Regeneron Pharmaceuticals, Inc. REGN on Monday released interim results from the ongoing Phase 2 COURAGE trial.

The company is investigating novel combinations of Novo Nordisk A/S NVO Wegovy (semaglutide) (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for obesity.

The trial demonstrated:

• Approximately 35% of semaglutide-induced weight loss was due to loss of lean mass
• Combining semaglutide with trevogrumab with or without garetosmab helped preserve lean mass while increasing loss of fat mass.
• Wegovy patients shed about 23 pounds in the study, about 7.9 pounds of which constituted lean mass.
• The trevogrumab and low-dose Wegovy combo led to about 21.6 pounds of weight loss, with 3.7 pounds in lean mass.
• At a higher dose, the trevogrumab combo therapy showed a weight loss of 24.8 pounds; 4.2 pounds in lean mass.
• A triplet combination of semaglutide plus trevogrumab plus garetosmab showed a weight loss of 30 pounds and 2 pounds in lean mass.

Also Read: Regeneron, Sanofi Stock Falls After Uneven Smoker’s Lung Drug Data

The combination of semaglutide with trevogrumab was generally well-tolerated; the triplet combination of semaglutide with both antibodies had a substantially higher rate of discontinuations due to tolerability issues and other adverse events, consistent with the safety profile previously seen with garetosmab alone.

After 26 weeks, patients enter into the weight-maintenance phase, receiving either higher-dose trevogrumab monotherapy or a placebo through the end of the trial (week 52).

Data from this phase are not yet available.

Regeneron also announced a strategic in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited. The company acquired clinical development and commercial rights outside the Chinese Mainland, Hong Kong and Macau for a dual GLP-1/GIP receptor agonist currently in Phase 3 testing.

Therapeutic candidate (HS-20094) – studied in over 1,000 patients and administered weekly subcutaneous injections – has demonstrated promising efficacy and safety clinical data, suggesting a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist.

A Phase 3 trial in obesity in China and a Phase 2b study in diabetes are ongoing.

Regeneron will pay Hansoh $80 million upfront. The deal may include additional payments of up to $1.93 billion if certain milestones are achieved.

Potential royalties for global net sales outside designated territories would be in the low double digits.

The company says the complementary asset enables synergy and flexibility across Regeneron’s broad pipeline of obesity and metabolic programs focused on improved quality of weight loss, co-morbidities, and long-term health.

Price Action: REGN stock is down 0.24% at $489.10 at the last check on Monday

Read Next:

• Loeb Rides Nvidia’s AI Wave, Bets Big On AT&T’s Telecom Comeback

Image: Shutterstock