There has been a growing demand for glucagon-like peptide (GLP)-1 agonist drugs to treat metabolic conditions like obesity and diabetes. These drugs mimic the GLP-1 hormone to stimulate insulin production, and are thought to slow digestion and reduce appetite, in efforts to aid weight loss.
Novo Nordisk’s obesity drug Wegovy has a major stake in the market having made 9.4 billion Danish kroner ($1.40 billion) in the first quarter of this year, since its approval in 2021. Lilly’s dual GIP/GLP-1 receptor agonist injectable Zepbound was greenlit late last year and made over a billion in sales this quarter.
Pharma giant Amgen’s investigational drug MariTide could give Novo Nordisk and Lilly a run for their money as it showed lasting results in the clinic earlier this year, and aims to conduct a phase 3 trial soon. Meanwhile, Pfizer is developing GLP-1 agonist danuglipron, which might be in the running to further slash drug prices as more and more drugs enter the market. And so are Swiss multinational Roche’s clinical candidates including its once-daily weight loss pill that has shown promise in early-stage studies.
As the therapeutic field seems to be brimming with candidates, in this article, we take a look at six biotech companies focused on bringing drugs to treat obesity to the market.
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Zealand Pharma
Danish biotech company Zealand Pharma is developing peptide therapies to treat metabolic diseases like type 1 diabetes and obesity as well as rare diseases and inflammatory conditions.
With a goal to manufacture drugs that target fat-specific weight loss while preserving muscle as well as comorbidities associated with obesity, Zealand’s clinical candidates aim to offer alternatives to incretin-based mechanisms.
Its phase 3 drug survodutide is a GLP-1 receptor dual agonist that works by activating the glucagon and GLP-1 receptors simultaneously that are meant to reduce body weight by both boosting energy burn and reducing food intake. The drug, which has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for metabolic dysfunction-associated steatohepatitis (MASH), has been licensed to German multinational Boehringer Ingelheim for its clinical development to manage obesity. In phase 2 trials, the drug showed up to 19% weight loss in patients after 46 weeks.
Zealand’s other weight loss drugs in the clinic include petrelintide and dapiglutide, both of which are in the phase 1 stage of development at the moment. Petrelintide is an amylin analog, meaning that it mimics the hormone amylin, which is released by the pancreas along with insulin. This class of drugs increase satiety by helping control blood sugar levels and preclinical data suggests that they have improved tolerability when compared to GLP-1 drugs. Dapiglutide on the other hand, is a dual agonist that is designed to accelerate weight loss with a GLP-1 agonist and address comorbidities associated with chronic inflammation by improving intestinal barrier function with the help of GLP-2.
The biotech has been in the limelight for a while now after it raked in $1 billion to enhance its pipeline, particularly its obesity candidates back in June.
Altimmune
American biotech company Altimmune has been put on the map since phase 2 data for its obesity therapy showed that its drug could go up against others in the market.
Pemvidutide is a GLP-1 dual receptor agonist that is being developed to treat obesity and MASH. Typical of a GLP-1 agonist, pemvidutide activates GLP-1 and glucagon receptors to help suppress appetite and increase energy expenditure. A phase 2 trial found that pemvidutide preserved lean mass with only 21.9% of weight loss related to lean mass, while other weight loss drugs lean mass loss accounts for almost 40% of weight loss. This is key because lean mass and maintaining muscle tissue are needed for healthy weight loss and physical function, according to Vipin K. Garg, chief executive officer (CEO) of Altimmune.
After 48 weeks of receiving pemvidutide, patients saw a decrease in weight loss by 10.3%, 11.2%, 15.6% and 2.2% with 1.2 mg, 1.8 mg, and 2.4 mg doses and placebo respectively. The drug led to reductions in serum lipids and improvements in blood pressure without irregularities in heartbeat or any heart-related effects. The results of the trial were presented at the American Diabetes Association’s 84th Scientific Sessions.
This comes after the investigational drug was given the FDA nod for fast track designation from the U.S. Food and Drug Administration (FDA) for MASH.
Viking Therapeutics
California-based Viking Therapeutics’ weight loss drug is not only an agonist of GLP-1 but also of glucose-dependent insulinotropic polypeptide (GIP) receptors. GIP influences how fat is deposited in tissues, and like GLP-1, is an incretin that is secreted after eating and stimulates insulin production.
The lead candidate VK2735 had encouraging results from a phase 2 trial where it achieved its primary endpoint and all secondary endpoints. The candidate showed statistically significant reductions in body weight compared with placebo, with up to 14.7% weight loss after 13 weeks of patients taking the drug. Up to 88% of patients in the treatment group had at least a 10% weight loss, if not more, compared with 4% for placebo. This led to an 80% hike in company shares earlier this year. It has been given the green light from the FDA to begin phase 3 for which there will have to be two trials conducted with a much larger patient population of at least 4,500 people.
Back in March, the biotech bagged $632.5 million to further develop VK2735 as well as its X-linked adrenoleukodystrophy and MASH drugs, which are in phase 1b and 2b trials, respectively.
Jiangsu Hengrui Pharmaceuticals
Been around for more than five decades, Chinese multinational Jiangsu Hengrui Pharmaceuticals has established itself as a biopharma that does it all – research and development (R&D), manufacturing, and commercialization. Its pipeline consists of numerous investigational drugs to treat cancer, autoimmune diseases, and metabolic diseases like diabetes and obesity.
The two notable obesity drugs of the company are HRS9531, a dual agonist of GLP-1/GIP and GLP-1 agonist HRS-7535. HRS9531, which has been licensed to American startup Hercules, wowed analysts and investors after a successful phase 2 trial. Patients who took the drug saw a decrease in weight of up to 17% after 24 weeks. The promise of the drug is evidenced by a $400 million investment to Hercules by life science investors for the continued development of the GLP-1/GIP agonist.
Jiangsu Hengrui’s oral incretin HRS-7535 is also in the phase 2 stage but patients have not been recruited yet. The study is expected to be completed early next year.
As part of its licensing deal with newly-formed Hercules, Jiangsu Hengrui could make up to $200 million if clinical and regulatory milestones are met, and up to $5.7 billion if the weight loss drugs are approved and marketed.
Structure Therapeutics
California-based Structure Therapeutics follows suit other obesity drug companies with its pipeline of oral incretin drugs. The most advanced out of all of them is phase 2 candidate GSBR-1290.
According to topline data published in June, the drug holds promise. GSBR-1290 was tested in a phase 2a study and a capsule to tablet pharmacokinetic (PK) study was conducted as well. In both studies, primary and secondary endpoints were met. In the phase 2a trial with GSBR-1290, 67% of patients had a reduction in weight by at least 6%, and 33% had a weight loss of more than 10% compared to 0% for placebo after 12 weeks.
The capsule to tablet PK study was designed to evaluate how well a new tablet formulation of the same drug would work. It demonstrated a placebo-adjusted mean weight loss of up to 6.9% after 12 weeks. Moreover, the new formulation’s pharmacokinetic data – based on how the body affects a drug – support the once-daily dosage of GSBR-1290 and the dose-proportional exposure of the drug. The daily dosage of up to 120 mg was found to be well-tolerable and safe.
Following phase 2 success, Structure closed a $547.4 million public offering in June. This comes after the biotech secured $300 million in a private investment in public equity (PIPE) late last year to support GSBR-1290’s development. The biotech has three more incretin drugs targeting metabolic diseases in preclinical stages.
Antag Therapeutics
Focused on bringing its peptide-based therapies to market, Danish biotech company Antag Therapeutics aims to treat obesity and postural orthostatic tachycardia syndrome (POTS) – a condition that leads to a sudden increase in the heart rate after getting up from sitting or lying down – with its medicines.
Regarded as a “leading contender” among GIP antagonists, according to Stifel’s Obesity Market Review report, Antag’s AT-7687 is a GIPR peptide antagonist and was combined with the GLP-1 agonist liraglutide in a preclinical trial. Based on proof-of-concept studies, the combination therapy was found to improve metabolic and cardiovascular results and aid in significant weight reduction.
The candidate, which was tested in obese monkeys, was an effective tool for weight management, and researchers think it could even potentially work as a standalone treatment. When AT-7687 was given alongside liraglutide, it had the best results in weight reduction and a major improvement in weight loss factors such as glycemic control and LDL-cholesterol levels were observed.
Now, the biotech is on a mission to raise funds of up to DKK 370 million ($54.73 million) as it gears up for clinical trials and currently relies on its DKK 24 million ($3.55 million) funding round that was held back in 2020.
A growing therapeutic field
The global market for obesity drugs is expected to hit $105 billion in 2030, more than $30 billion higher than a previous forecast owing to surging demands, according to a report by Morgan Stanley.
And in research and development (R&D), this field is only growing. Beyond GLP-1 agonist drugs, Glyscend Therapeutics’ medicines are based on its polymer therapeutic platform that are taken orally and can non-invasively mimic the effects of obesity management surgery. Swiss biotech Aphaia Pharma’s phase 2 drug aims to restore metabolic balance with its oral formulation of coated glucose beads. Massachusetts-based Fractyl Health’s gene therapy, which contains a transgene that secretes GLP-1 into cells in the pancreas, aided weight loss in mice. This could be game-changing if it does well in the clinic.