The GLP-1 Gold Rush Continues

A 2024 report from GlobalData has revealed that in spite of approaching headwinds in the obesity market, glucagon-like peptide-1 (GLP-1) receptor agonists will continue to generate blockbuster sales. The analysis projected that sales will reach a total value of $111 billion by 2033 after achieving $25 billion in 2023 in the US, France, Spain, Germany, Italy, Japan, and the UK.

Obesity is a rising public health concern that affects 42% of adults in the US, and over one billion people worldwide. It is associated with an increased risk of overall mortality and serious health conditions, including high blood pressure, high cholesterol, type 2 diabetes, heart disease, stroke and cancer. Safe and effective obesity treatments remain a critical unmet need.

GLP-1 drugs have changed the obesity treatment landscape, aiding weight loss by regulating appetite and food intake, and enhancing weight maintenance. However, despite their significant impact, these medications bring with them a number of side effects, and compliance issues for patients who prefer not to administer regular injections. Healthcare professionals have also raised concerns about muscle loss, with studies suggesting that up to 40% of weight lost may come from lean muscle tissue.

Regeneron (REGN) and others are exploring treatments that mitigate this loss of muscle mass. The company will begin enrolling a study in mid-2024 to evaluate the combination of monoclonal antibodies with GLP-1 drugs, semaglutide and tirzepatide, in a study targeting muscle loss in obese patients.

Beyond Regeneron’s work, and the industry -leading Novo Nordisk’s (NVO) Ozempic and Wegovy, and Eli Lilly’s (LLY) Zepbound, PRISM MarketView takes a look at four companies developing different mechanisms of action for obesity treatments to meet future demand.

Vivani Medical (VANI)

Vivani Medical is advancing NPM-115 and NPM-139 as treatments for chronic weight management. Last week, the company received FDA clearance of its Phase 1 study evaluating the company’s miniature, six-month GLP-1 implant in development for the treatment of type 2 diabetes. Adam Mendelsohn, Ph.D., Vivani President and Chief Executive Officer, said, “The results of the study will also apply to our lead program, NPM-115, which is under development for chronic weight management and demonstrated weight loss comparable to injections of semaglutide, the active ingredient in blockbuster products Ozempic® and Wegovy®, in preclinical studies earlier this year.” Vivani’s share price is currently $1.66 and it has a market cap of $91.26 million.

Tonix Pharmaceuticals (TNXP)

Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company with a development portfolio focused on central nervous system disorders. In March 2024, Tonix received Rare Pediatric Disease Designation from the FDAfor TNX-2900 for the treatment of Prader-Willi syndrome. TNX-2900 is the company’s proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating. PWS is recognized as the most common genetic cause of life-threatening childhood obesity. Tonix’s share price is $1.15 and its market cap stands at $3.43 million.

Palatin Technologies (PTN)

Last week, biopharmaceutical company, Palatin, announced the initiation of a Phase 2 clinical study of bremelanotide for the treatment of obesity. The study will evaluate the safety and efficacy of bremelanotide co-administered with tirzepatide (GLP-1/GIP) in obese patients. Topline data results are expected in the fourth quarter of 2024. Carl Spana, Ph.D., CEO and President of Palatin, commented, “We believe co-administering an MC4R agonist with a GLP-1 agonist will achieve significant weight loss at lower doses, with improved tolerability and quality of life for these patients.” Palatin’s share price is currently $1.82 and its market cap stands at $29.40 million.

Wave Life Sciences (WVE)

Biotechnology company, Wave Life Sciences, is addressing the unwanted side effects, poor adherence, and rebound weight gain that can result from GLP-1 usage with its INHBE (Inhibin βE) program. The program is a best-in-class approach for obesity designed to induce fat burning and preserve muscle mass with once or twice-annual subcutaneous administration. Wave expects to initiate a clinical trial for its INHBE candidate in 1Q 2025.Erik Ingelsson, MD, PhD, Chief Scientific Officer at Wave Life Sciences, said, “Our INHBE silencing program reimagines obesity treatment, focusing not just on weight loss, but on the restoration and maintenance of a healthy metabolic profile.” Wave’s share price is $6.23 and its market cap is currently $762.92 million.