Eli Lilly & Co. Inc.’s /zigman2/quotes/200106384/composite LLY +1.34% promising new weight-loss drug is taking aim at a sector that’s littered with once-promising therapies that have failed to deliver on their promise to help people lose weight.
The company made two announcements on Thursday; it shared its first-quarter earnings as well as top-line Phase 3 clinical trial results for the experimental weight-loss drug, tirzepatide.
Lilly’s late-stage study enrolled 2,539 participants who were either obese or overweight with at least one comorbidity. None had diabetes. Lilly said that the participants lost, on average, between 16.0% and 22.5% of their body weight after 72 weeks. More than 96% of patients taking a 10-milligram or 15-milligram dose reported at least 5% weight loss, executives said.
The most common adverse events were nausea and vomiting, and about 7% of the participants decided to discontinue their participation in the trial.
“The more than 20% weight loss is really unprecedented level of weight loss in the field,” Daniel Skovronsky, Lilly’s chief scientific and medical officer, said Thursday, according to a FactSet transcript of the earnings call. “That’s exciting for patients in addressing a very significant unmet medical need.”
The clinical data for the drug revealed a better-than-expected weight-loss threshold, while the ability of participants to tolerate the drug came in as expected, according to Mizuho Securities analyst Vamil Divan. “The combination of the two suggests a multibillion-dollar opportunity for the drug in the obesity indication, on top of the multibillion-dollar opportunity it already likely has in patients with diabetes,” he told investors in a note on Thursday.
Drug makers have long struggled to develop weight-loss therapies that work and that have a side effect profile that is manageable for the people who take them.
That said, there is a new wave of weight-loss treatments in development and early-stage commercialization, including Lilly’s tirzepatide and Novo Nordisk’s /zigman2/quotes/207193277/delayed DK:NOVO.B -1.60% Wegovy, which was approved last summer by the Food and Drug Administration as a weight-management medication. Novo also has a drug called cagrisema in a Phase 1 clinical trial for an obesity indication.
“The critical point commercially is far less about exact comparisons to Novo and more about being in the right range to convince patients and physicians to use the drug,” Bernstein analysts told investors on Thursday. “A physician can tell a patient they would lose 12%. This is rather convincing.”
Developing weight-loss drugs isn’t easy. Arena Pharmaceuticals Inc., which was recently acquired by Pfizer Inc. /zigman2/quotes/202877789/composite PFE +0.89% for $6.7 billion, sold its weight-loss drug Belviq to Eisai Co. Ltd. in 2017. Three years ago, Eisai withdrew the drug from the U.S. market after the FDA said longer-term data showed the benefits of Belviq do not outweigh the risks. Orexigen Therapeutics Inc., which received FDA approval in 2014 for its weight-loss drug, Contrave, was sold to Nalpropion Pharmaceuticals (now owned by the privately held Currax Pharmaceuticals) after filing for bankruptcy in 2018.
But about 40% of Americans are obese , and that’s why the pharmaceutical industry is keen on developing new treatments. In the case of the Lilly drug, executives say they expect people would need to take the drug “long-term to get the benefit,” according to Mike Mason, president of Lilly’s diabetes business. If that’s the case, this could create a steady and lucrative stream of revenue for Lilly.
“It should be perceived and treated as a chronic illness,” Mason said. “The market’s not going to develop overnight. We have to increase awareness that this is a chronic disease that needs to be treated. We do need to establish and grow the access for it.”
Wall Street analysts expect new weight-loss drugs to be more effective than the ones that are currently on the market although they still have questions about adherence, particularly when it comes to the gastrointestinal side effects that can occur with these drugs.
“The next wave of innovation will need to be about improving adherence — whether by wrapping services around the client or developing easier to take/tolerate drugs,” the Bernstein analysts said.
Lilly is also testing tirzepatide as a treatment for heart failure, nonalcoholic steatohepatitis (NASH), and diabetes.
Lilly’s stock is up 7.6% for the year, while the S&P 500 /zigman2/quotes/210599714/realtime SPX +1.45% has declined 10.0%.