GLP-1s, ADCs, AI and the future of pharma

Pharma’s potential breakthroughs in AI, ADCs, and GLP-1 receptor agonists raise a critical question: can innovation outpace the relentless rise of chronic disease?

The IQVIA Institute for Human Data Science sheds light on this theme, among many others, in its 80-page Global Trends in R&D 2024 report.

Pillar 1: GLP-1 receptor agonists targeting metabolic disease

Speaking of next-gen metabolic therapies in particular, Murray Aitken, the executive director of the IQVIA Institute for Human Data Science, sees significant potential. Market projections for GLP-1 drugs are bullish, with some analysts projecting sales potentially hitting $100 billion by 2030. “It’s exciting because if the market for these drugs becomes as big as anticipated, it means they are truly being disruptive in a positive way to human health for hundreds of millions of people worldwide,” said Aitken

New metabolic therapies are sorely needed as the obesity epidem…

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Beyond GLP-1: OrsoBio targets mitochondria to treat metabolic disorders from a new and potentially complementary angle

Emerging from stealth in late 2022, Palo Alto–based biopharma startup OrsoBio announced four development programs targeting severe metabolic disorders. The CEO and founder, Dr. Mani Subramanian and chief medical officer and head of development Dr. Rob Myers formerly worked at Gilead. Founded in 2020 with a quest to “try to modulate energy metabolism in severe metabolic disorders like obesity, diabetes, dyslipidemias, NASH, etc.,” as Myers put it, the company focuses on drug targets that affect fundamental aspects of mitochondrial function. 

To date, OrsoBio has completed a $60 million Series A financing round, bringing its total fundraising total to $97 million. Longitude Capital and Enavate Sciences co-led the fundraising, with significant participation from existing investors Samsara BioCapital and NuevaBio. The round also brought in a notable new investor — Eli Lilly. Lilly’s stock has nearly doubled over the past year, thanks in part to its FDA approval of t…

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Another surgical robotics CEO says GLP-1s could boost bariatric surgeries

Levita Magnetics founder, CEO and President Dr. Alberto Rodriguez-Navarro [Photo courtesy of Levita Magnetics]

The rise of glucagon-like peptide-1 (GLP-1) weight loss drugs will likely increase demand for bariatric surgeries in the long run, according to Levita Magnetics founder, CEO and President Dr. Alberto Rodriguez-Navarro.

He’s the latest CEO of a surgical robotics developer to weigh in on how these novel drugs could affect demand for bariatric procedures and the wave of robotic systems being launched to perform them.

In an interview with Medical Design & Outsourcing, Rodriguez-Navarro says he views GLP-1 drugs like Ozempic and Wegovy in the same way as previous advances like intragastric balloons that were hailed as obesity solutions.

“Down the line, you stop using those treatments and the people regain the weight, because obesity’s a multifactorial, very complex diseas…

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How Medtronic evaluates its exposure to GLP-1 drugs

Medtronic Chief Scientific, Medical and Regulatory Officer Dr. Laura Mauri drills into GLP-1 drug trial results to estimate their impact across the portfolio.

“We’ve done all the analysis” on GLP-1 drugs across Medtronic’s portfolio, said CEO and Chair Geoff Martha. [Photo courtesy of Medtronic]

The impact of glucagon-like peptide-1 (GLP-1) drugs like Ozempic and Wegovy on medtech manufacturing is one of the biggest uncertainties heading into 2024.

Industry leaders like Medtronic, Stryker and Intuitive have faced questions from investors about whether these weight loss drugs will reduce demand for certain medical devices and procedures.

Despite a portfolio spanning some of the fields that would seem likely to be affected — such as cardiovascular, diabetes, surgical and neurovascular — Medtronic Chair and CEO Geoff Martha recently said the drugs won’t impact his company’…

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Medtronic weighs in on GLP-1 impact for device manufacturers

Medtronic CEO and Chair Geoff Martha [Photo courtesy of Medtronic]

Medtronic is the latest — and largest — device manufacturer to weigh in on GLP-1 weight loss drugs and how they could affect demand for medical devices.

Medtronic Chair and CEO Geoff Martha today said the world’s largest medical device company doesn’t expect GLP-1 (glucagon-like peptide-1) drugs like Ozempic and Wegovy to take a big bite out of its business.

While Medtronic said the drugs have had a “modest impact” on the bariatric surgery market, Medtronic thinks that is only temporary. The rate of decline in Medtronic’s bariatric business has already stabilized, Martha said on the company’s second-quarter earnings call, adding, “I think we see that coming back in the coming year.”

“We feel strongly that we don’t see these drugs impacting Medtronic’s growth, medium …

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Lilly publishes promising phase 2 trial data for retatrutide, a potential obesity therapy

Lilly has announced promising data from its NCT 04881760 phase 2 study of retatrutide, a potential obesity drug. The drug candidate, a single peptide with agonist activity at the glucose-dependent insulinotropic polypeptide (GIP), GLP-1 and glucagon receptors, was associated with significant weight loss, improved glycemic control and cardiovascular health.

At 24 weeks, retatrutide (1 mg, 4 mg, 8 mg or 12 mg) met the primary endpoint for efficacy in participants with obesity or overweight without diabetes. Participants had a mean weight reduction of up to 17.5% (41.2 lb) at 24 weeks. That figure increased to 24.2% at 48 weeks.

The double-blind, randomized, placebo-controlled study enrolled 338 adults with obesity or overweight and related health conditions to assess the drug’s efficacy, side effects, and safety. Data from that study were published in NEJM.

Lancet recently published data from the separate phase 2 NCT04867785 study on  retatrutide, in…

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What’s so special about Apollo Endosurgery’s stomach-shrinking weight loss tech?

The Apollo Endosurgery OverStitch Sx endoscopic suturing system [Image courtesy of Apollo Endosurgery]

Apollo Endosurgery — set to be purchased by Boston Scientific for $615 million — develops new devices and minimally invasive procedures for weight loss.

The procedure is called endoscopic sleeve gastroplasty (ESG) and the device that made it possible is the OverStitch endoscopic suturing system.

Austin, Texas-based Apollo Endosurgery first won 510(k) clearance for OverStitch in 2008, with successive clearances for improved designs over the years. Most recently, in July the FDA granted de novo clearance for Apollo Endosurgery’s Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx systems. They’re the first FDA-authorized devices for ESG and endoscopic bariatric revision procedures.

Medical Design & Outsourcing spoke with Apollo Endosurgery Chief Medical Officer Dr. Christo…

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Novo Nordisk to test oral semaglutide as an obesity therapy

Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity. 

The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’ risk of major adverse cardiovascular events. 

The most recent Phase 3a trial will test an oral 50-mg dose of the drug with roughly 1,000 volunteers who are obese or overweight with comorbidities. 

The company anticipates that the 68-week study will kick off in the second half of 2021. 

Recent clinical trial results indicate that subcutaneous semaglutide paired with behavioral therapy can support weight loss. 

Novo Nordisk has also filed a new drug application with the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management. The company is seeking a similar indication in the European m…

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Semaglutide shows promise for weight loss maintenance 

Signs are growing that the diabetes drug Ozempic (semaglutide) from Novo Nordisk can support weight loss in overweight and obese individuals.

A recent JAMA study involving overweight and obese individuals gave recipients a 2.4-mg subcutaneous dose of semaglutide once weekly for 20 weeks. After that period, investigators continued administering the drug to half of the participants while giving the placebo to the remainder for an additional 48 weeks.

The group that continued to receive semaglutide lost an average of 7.9% of their body weight from week 20 to week 68. By contrast, placebo recipients gained 6.9% of their body weight in the same time frame.

Complicating matters were gastrointestinal side effects, reported in 49.1% of participants who continued to receive subcutaneous semaglutide. A total of 26.1% of placebo recipients also reported gastrointestinal side effects.

The study authors conclude that semaglutide supports weight loss by improvi…

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Semaglutide paired with behavioral therapy tripled weight loss in trial

The diabetes drug Ozempic (semaglutide) could potentially enhance weight loss in overweight and obese patients without diabetes, according to a study recently published in JAMA and The New England Journal of Medicine.

In December, Novo Nordisk (NYSE:NVO) submitted a new drug application to the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management.

The drug won FDA approval to manage type 2 diabetes in 2017

The 68-week randomized Phase 3a study involved 611 patients. At the end of the period, patients given weekly semaglutide lost 16% of their body weight while the placebo group lost 5.7%.

Participants in the trial received physical activity counseling. At the beginning of the trial, they received an eight-week meal replacement diet of 1000 to 1200 calories per day.

Some 3.4% of semaglutide recipients had gastrointestinal adverse events, and treatment for them was discontinued.

The study was conducted from Au…

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Obalon Therapeutics’ stock skyrockets after announcing ReShape Lifesciences merger

Shares of intragastric balloon maker Obalon Therapeutics (NSDQ:OBLN) jumped as high as $10.71 today, or 568%, after the company announced a merger with ReShape Lifesciences (OTCMKTS:RSLS). 

The San Diego-based company’s stock eventually closed at $9.52 per share, up 491%.

Obalon’s stock had closed at $1.61 yesterday. 

ReShape Lifesciences also saw a substantial jump in its stock price. RSLS shares closed at $9.52 per share, up nearly 138%.

Obalon won FDA-approval for its gas-filled intragastric balloon system for obesity in 2016. It is currently the only company with such a product on the market in the U.S. 

The merger with ReShape will allow the balloon system to become part of a portfolio of devices used to treat obesity and metabolic disease, including the Lap-Band adjustable gastric banding system and the ReShapeVest, which is an investigational device for treating obesity.  

“We are excited with this opportunity to add Obalon’s …

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