Eli Lilly and Company announced on Thursday that in a late-stage clinical trial, its closely watched oral obesity drug helped patients maintain most of their weight loss after they directly stopped taking the company's tilpotide injection and Novo Nordisk's rival semaglutide injection.
The company also said it has submitted a marketing application for the obesity indication of ofofogliptide, a daily GLP-1 oral drug, to the U.S. Food and Drug Administration (FDA). The U.S. Food and Drug Administration granted the drug approval in NovemberPriority Review Eligibility, this qualification is expected to shorten the review cycle to a few months.
Positive trial data suggest the oral drug may be an effective bridge treatment option for patients who want to maintain weight loss but don't want long-term weekly injections. Many patients experience significant weight regain after stopping injection therapy.
Although the overall weight loss effect of Eli Lilly's oral drug does not appear to be as good as existing injectable forms, the trial results announced this time highlight its potential to become an injection-free weight loss maintenance treatment option in the hot GLP-1 drug market. However, Novo Nordisk’s oral obesity drug is likely to be launched first, which will give the Danish pharmaceutical company a first-mover advantage in this segment.
The phase 3 clinical trial included more than 300 obese patients who had been treated with semaglutide or tilpotide for 72 weeks in a separate late-stage study. The patients were then randomly assigned to receive either Eli Lilly's oral drug or a placebo for the next 52 weeks. The results of the study showed that for patients whose weight loss had hit a bottleneck during previous injection treatments, this oral drug was significantly better than placebo in maintaining weight loss, reaching the primary endpoint of the trial.
The data showed that patients who switched from Novo Nordisk's semaglutide injection to this oral drug regained only about 2 pounds (about 0.9 kilograms) of weight on average at the end of the trial; while patients who switched from tilpotide injection to the oral drug regained an average of about 11 pounds (about 5 kilograms) at the end of the trial.
"Obesity is a chronic progressive disease, and maintaining weight loss remains a significant challenge for many patients," Kenneth Custer, president of Eli Lilly's Cardiometabolic Health division, said in a press release.
He pointed out that the clinical trial showed that the oral drug "can help people maintain their hard-won weight loss." If approved for marketing, it will "provide millions of obesity patients around the world with a convenient alternative and help them embark on the road to long-term health management."
Although patients who switch from tilpotide to oral drugs have a relatively greater weight rebound, the market's focus may be more on the group of patients who switch from Novo Nordisk's core competitor to oral drugs.
Evan Segelman, an analyst at BMO Capital Markets, said in an October report that if the clinical trial yields positive results, Eli Lilly and Company will have a "unique opportunity" to acquire the drug from Novo Nordisk's smeglutide, which is also Novo Nordisk's diabetes treatment.Semaglutide injectionactive ingredients) to seize a certain revenue share in the chronic treatment market.
"This will gradually weaken the market potential of Novo Nordisk's flagship product," Segelman wrote in the report.
The overall safety and tolerability of this oral drug was consistent with previous late-stage clinical trial results. The most common side effects are gastrointestinal-related reactions, and the severity is mostly mild to moderate.
Data show that about 4.8% of patients who switched from semaglutide injection to this oral medicine discontinued due to side effects; among patients who switched from tilpotide injection to oral medicine, this proportion was 7.2%. By comparison, discontinuation due to side effects was 7.6% and 6.3% of patients who switched from semaglutide and tilpotide to placebo, respectively.
Eli Lilly said no liver safety-related issues were observed in the trial. This item is calledATTAIN-MAINTAINFull results from the clinical trial will be presented at an upcoming medical conference and are scheduled to be published in a peer-reviewed journal next year.
The mechanism of action of Eli Lilly's oral drug is similar to that of semaglutide, semaglutide injection and Novo Nordisk's oral diabetes treatment.Semaglutide tabletsSimilarly, both work by targeting glucagon-like peptide-1 secreted by the gut to suppress appetite and regulate blood sugar. Novo Nordisk is also applying for an obesity indication for an oral formulation of semaglutide, which is expected to be approved before the end of the year.
But unlike the above three drugs, Eli Lilly’s oral drug is not a peptide drug. This means it is absorbed more efficiently into the body and does not require patients to adhere to special dietary restrictions like semaglutide tablets or semaglutide oral formulations.
Goldman Sachs analysts predicted in an August report that the global weight-loss drug market will reach $95 billion by 2030, with oral drugs accounting for 24% of the market, or about $22 billion.
Analysts also predict that Eli Lilly’s oral drug will account for 60% of the daily oral weight-loss drug segment by 2030, equivalent to approximately $13.6 billion; while Novo Nordisk’s oral semaglutide is expected to account for 21% of the market share, equivalent to approximately $4 billion.