Dive Brief:
- An experimental GLP-1 pill helped people with obesity lose significantly more weight than a placebo over three months, according to summary results revealed by developer Structure Therapeutics Monday.
- In the Phase 2a study, which enrolled 64 healthy individuals who were obese or overweight, Structure’s drug led to an average reduction in body weight of 6.2% over placebo. One-third of those on the drug, dubbed GSBR-1290, lost 10% or more of their body weight, compared to zero of those given placebo.
- Shares in Structure soared by more than half on news of the data, reaching near the stock’s price in mid-December before data from another of the company’s trials disappointed. Structure is moving forward with a Phase 2b of GSBR-1290 that will test other doses.
Dive Insight:
Many companies hope to compete with Novo Nordisk’s and Eli Lilly’s fast-selling GLP-1 drugs for diabetes and weight loss. Structure is among them and, like several others, is working on developing a treatment that can be taken orally, rather than injected like Novo’s Wegovy or Lilly’s Zepbound.
In December, the biotechnology company disclosed results from a study of GSBR-1290 in people with Type 2 diabetes. While treatment helped lower blood sugar, the weight loss data were below analysts’ expectations. Shares tumbled in response.
Monday’s readout has given Structure something of a rebound. In addition to the Phase 2a study data, the company also disclosed results from a “pharmacokinetic” trial testing a tablet form of GSBR-1290 rather than capsule. Among 54 people in that trial, the average weight loss ranged between 6.2% and 6.9% versus placebo, depending on the dose.
Analysts at Leerink Partners and Cantor Fitzgerald described Structure’s data as competitive to results seen with a GLP-1 pill Lilly is testing called orforglipron.
Common side effects to treatment with GSBR-1290 were nausea and vomiting, although Structure said they mostly occurred early on and lessened as dosing was adjusted. Five percent of participants in Phase 2a study discontinued due to adverse events, as did 11% in the pharmacokinetics study. There were no cases of liver injury or persistent increases in liver enzymes, Structure said.
David Risinger, an analyst at Leerink Partners, wrote in a note to clients that a monthly titration schedule should “significantly benefit tolerability.”
Small molecule pills like GSBR-1290 and orforglipron could also be easier to take and cheaper to produce at scale than Wegovy and Zepbound.
Structure plans to start a 36-week Phase 2b obesity study in the fourth quarter. In a statement, CEO Raymond Stevens said the company believes it can “explore higher doses in future studies.”
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- Source: https://www.biopharmadive.com/news/structure-obesity-pill-drug-trial-results-weight-loss/717768/