This year, competition in the obesity therapeutic landscape has ramped up as biotechs aim to follow the success of blockbuster drugs from Novo Nordisk, Eli Lilly and more. Now, in this hunt for new drugs, small to medium enterprises (SMEs) are also taking their chances in the quickly growing marketplace, with new methods of targeting obesity.

This topic was at the forefront of a panel on obesity drug development. At the Bio-Europe Spring 2023 conference held on 20-23 March. With more companies entering the obesity market, biotechs are either identifying new GLP-1 agonists to investigate or straying from the currently popular GLP-1 agonism approach in favour of other modalities. At the panel, Italy-based Resalis Therapeutics’s CEO Allesandro Toniolo, described the company’s micro-RNA 22 (miRNA 22) drug as one that will target multiple pathways for targeting obesity. He said, “miRNA 22 acts on three major pathways: lipogenesis and deposition, mitochondria and energy expenditure, and collagen deposition and fibrosis. The level of miRNA22 correlates with these factors, affecting the severity of obesity and Nonalcoholic steatohepatitis (NASH)”. Resalis is developing an antisense oligonucleotide therapy, RES 010, to inhibit miRNA 22.

Additionally, on March 28, Viking Therapeutics announced the launch of Phase I trial to study its oral dual GLP-1/GIP receptor agonist VK2735.

However, several challenges remain in the field of obesity drug development. “[Research] requires huge trials and it’s not clear how a comparison should be made, whether it’s placebo or standard of treatment. The regulatory pathway in diabetes is particularly difficult,” says Toniolo, while describing clinical trials for metabolic disorders. In the panel, Melanie Senior, a biopharma reporter at Nature Biotech also pointed out reimbursement issues for obesity drugs. Toniolo said this is a reason that Resalis’ drug will first enter clinical trials for NASH and rare diseases, before moving on to obesity.

Still, despite some barriers, the success of Novo Nordisk’s Wegovy (semaglutide), Eli Lilly’s Mounjaro (tirzepatide) and more have shown significant success.

Josua Jordi, the CEO of EraCal Therapeutics, another company developing drugs in this space, said obesity could grow as an indication in the coming years. “We see it becoming something like hypertension in the next 10-15 years where patients can select between three to four once daily oral modalities,” said Jordi. Resalis Therapeutics plans to start first in human trials next year and EraCal Therapeutics is still in preclinical stages with developing its small molecule drug, Era-379, for obesity. EraCal already has partnerships with Nestle and Novo Nordisk for research collaboration.

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By GlobalData