Eli Lilly On Thursday, he said the highest dose of his daily obesity pill helped patients lose almost 12% of their body weight, or approximately 27 pounds, at 72 weeks in a late test in the late stage, racing the way for their entrance to the market.
The weight loss of the pill was 11.2% when analyzing all patients, regardless of interruptions.
The company's shares fell around 13% on Thursday. Meanwhile, rival actions Novo Nordiskwhich is also working to bring a pill of obesity to the market, jumped more than 7% on Thursday.
The data is under what some Wall Street analysts expected for the oral LLP-1 of Eli Lilly, hoping a weight loss of around 15%. Some doctors said the results seem comparable, but in general slightly lower, the level of weight loss observed with Novo NordiskWeekly GLP-1 injection by obesity, Wagovy.
Some doctors also took note of the number of patients in the highest dose of the pill that suspended the treatment due to side effects or any other reason in the trial.
Even so, other doctors praised the results and potential of the pill to reach new patients, such as those who fear needles.
“This is a strong and promising result for an oral agent,” said Dr. Jaime Almondoz, medical director of the weight welfare program at the UT Southwestern Medical Center, qualifying weight loss “a significant and clinically significant result.”
“Injectables have established a high bar, but this study reinforces the potential that an oral LPG-1 is a transformative in obesity care, particularly for patients who hesitate to start or maintain injectable therapies,” he continued.
Dr. Mihail “Misha” Zilbermint, director of Endocrine Hospitalists of doctors of the Johns Hopkins community, said she believes that the pill “has the potential to change the game, provided that people can tolerate side effects.”
The results of the trial are among the most monitored studies of the pharmaceutical industry of the year and follow the positive data in April from a three phase test that examines the experimental pill in patients with diabetes. They bring the Eli Lilly pill, orforglipron, one step closer to potentially becoming a new needle without dietary restrictions in the booming market for weight loss and drugs of diabetes called LPG-1.
Eli Lilly “is not disappointed with these results. It is right in the thesis for us”, despite being “one or two points below what the street had,” CEO David Ricks said Thursday “Squawk Box” of CNBC.
“The objective was to create an oral pill that was convenient and that can be made on a large scale, really, for the mass market, and had a weight loss that was competitive with other unique action LPG-1, and that is what we have achieved,” Ricks said. He added that the percentage of weight loss of the pill is “in the range” of what most people who are overweight or want to improve their metabolic health want to achieve.
Ricks said Eli Lilly hopes to present the data to the regulators by the end of the year, hoping to launch the pill worldwide “this time next year.”
This launch could fundamentally change space, helping more patients access treatments and relieve the supply deficit of existing injections. The most convenient and easiest manufacturing pill could also help Eli Lilly solidify their domain in the growing segment such as other medication manufacturers, including its main rival Novo Nordisk, the race to carry the pills of loss of weight to the market.
There are approximately 8 million patients with injectable obesity and diabetes medications, but probably around 170 million that could benefit from medications, said Ken Custer, president of Lilly Cardiometabolic Health, in an interview.
“To meet that demand, we will need other options, including oral small molecules such as orforglipron, which use different means of production and do not need such sophisticated supply chain to distribute it to patients,” he said.
Dr. Amy Sheer, Professor of Medicine and Programs Director of the Obesity Medicine Scholarship of the University of Florida, said she hopes that the pill will be less expensive than the existing injections, which are expensive in large part due to the devices in which they arrive. He said that the lowest prices could help eliminate barriers to access patients, which can make insufficient are more willing to cover the medication.
Many insurers still do not cover LPG-1 by obesity. Wegovy and other medications have a list prices of approximately $ 1,000 before insurance.
Detailed test results
The highest dose of Eli Lilly's pill helped more than 59% of patients lose at least 10% of their body weight and more than 39% of patients lose at least 15% of their weight, according to the results of the trial.
Almandoz said that the proportion of people who achieved “greater magnitudes” of weight loss was “very impressive for an oral agent”, adding that many people “often overlook the proportion of people who achieve these categories of high weight weight loss” and generally focus closely on the average weight loss.
Orforglipron also helped reduce cardiovascular risk factors.
But the data about how well some patients tolerated the pill in the trial were found under the estimates of some analysts.
About 10.3% of the patients who took the highest dose of the pill, 36 milligrams, discontinued the treatment due to side effects, compared to around 2.6% of those who took a placebo. These side effects were mainly gastrointestinal, such as nausea and vomiting, and mild to moderate gravity. It is estimated that 24% of those who took the highest dose experienced vomiting, while 33.7% and 23.1% had nausea and diarrhea, respectively.
Before the data, the BMO capitalist Markets Evan Seigerman said he expected less than 10% of patients in the highest dose of the pill to suspend the treatment due to side effects and the lowest rates of vomiting, nausea and diarrhea.
More patients stopped taking the pill due to side effects compared to the existing GLP-1, said Dr. Caroline Apovian, co-director of the Center for Weight Management and Welfare in Brigham and Women's Hospital. The interruption rates due to the side effects in the late -stage tests in the weekly obesity injection of Wegovy and Eli Lilly are around 7% or less.
He pointed out that almost a quarter of the patients in the highest dose of the pill suspended the treatment for any reason, warning that the enthusiasm for orforglipron should be tempered “because we get all this emotion, and then the pill comes out, and then no one can take it.”
It is not clear why, apart from the side effects, these patients suspended the pill. Almost 30% of those in a placebo suspended treatment for any reason.
Ricks de Eli Lilly said the company is not worried about those abandonment rates of the study.
“What we really want to see is that the rate of abandonment of medicine is lower than placebo, and that is what we saw here,” he said, referring to interruption rates for any reason.
Ricks added that Eli Lilly was looking for an abandonment rate of less than 12% due to side effects, noting that the industry has seen rates from 8% to 12% with GLP-1 medications.
“We are in the middle,” he said. “The continuation rates in this category, in all categories of chronic medicines, are not perfect. But the abandonment of the medication is what we pay attention, and here again, we are just with the profile.”
Sheer of the University of Florida said he does not believe that interruption rates or side effects will be a decisive factor for doctors when prescribing the pill.
She believes that an oral option could make more doctors feel more comfortable by recipeing a LPG-1 to patients. Currently, some doctors hesitate to prescribe injections because “they may not know how to tell patients how to use them,” Sheer added.
Almandoz said that prescription decisions will depend on the specific needs and preferences of the patient, as well as access and affordability. An injectable LP-1 may be the preferred option for patients whose priority is a higher level of weight loss or those that have significant cardiomethabolic complications, or health problems that arise from cardiovascular diseases and metabolic disorders.
But an oral LPG-1 could be the best option for those who “prioritize simplicity or convenience or have these logistics challenges with injections,” he said.
The detailed results of the trial will be presented in September at a European medical meeting and will be published in a peer reviewed magazine. More results from phase three in the pill will be shared later this year, even a study on adults that have obesity or have overweight and have type 2 diabetes.
Wegovy, Eli Lilly's pill, the Orforgripron and Novo Nordisk diabetes pill, goes to an intestinal hormone called LPG-1 to promote weight loss and regulate blood sugar. But unlike those other medications, Eli Lilly's pill is not a peptide medication. That means that it is more easily absorbed in the body and does not require dietary restrictions as Rybelsus does.
Currently, Eli Lilly is approximately three years ahead of other drug manufacturers that develop pills, including Pfizer, Astrazeneca, Roche, Structure Therapeutics and Viking Therapeutics, Guggenheim analyst Seamus Fernández previously CNBC.
Some analysts hope that the LPG-1 market is more than $ 150 billion annually in the early 2030s. Oral LPG-1 could grow to assert $ 50 billion of that total, said Fernández.
– Angelica Peebles de CNBC contributed to this report.
