American biopharmaceutical company Viking Therapeutics is actively developing several candidates aimed at treating metabolic disorders.

Among these is VK2735, a dual glucagon-like peptide-1 receptor (GLP-1R)/gastric inhibitory polypeptide (GIP) receptor agonist, which is being investigated both as a weekly subcutaneous (SC) injection and as an oral tablet to treat obesity.

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According to leading data and analytics company GlobalData, this candidate may enter the market within the next few years and could become a direct competitor to Eli Lilly’s Mounjaro (tirzepatide), the only dual GLP-1/GIP receptor agonist currently approved.

The obesity market continues to expand, yet the therapeutic options remain limited and are currently experiencing shortages in supply, creating significant opportunities for new entrants.

Numerous companies are exploring potential breakthrough mechanisms of action (MoA) beyond GLP-1R agonists while others are focusing on the synergistic effects of targeting multiple receptors to enhance the benefits of GLP-1R agonists.

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In February of this year, Viking Therapeutics published Phase IIa results for its VK2735 candidate, which demonstrated significant reductions in body weight after 13 weeks of treatment.

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The study investigated four doses – 2.5mg, 5mg, 10mg, and 15mg – for safety, pharmacokinetics, and efficacy.

Each cohort, including the placebo group, consisted of 35 participants. Patients’ body weight was measured at the beginning and end of the trial to assess changes.

The results showed that after 13 weeks of once-weekly SC injections of VK2735, patients experienced average weight losses of 9.2kg, 10.7kg, 13.3kg, 14.6kg, and 1.8kg in the 2.5mg, 5mg, 10mg, 15mg, and placebo groups, respectively.

This translates to a placebo-adjusted weight loss from baseline of 7.4%, 9.2%, 11.3%, and 13.10% in the treatment groups.

The study met all its primary and secondary endpoints, demonstrating statistically significant weight loss effects and a favourable safety profile.

Consequently, following a written response to the company’s Type C meeting with the US Food and Drug Administration, if everything proceeds according to Viking Therapeutics’ plans, the company could save hundreds of thousands of dollars by advancing directly to Phase III trials, potentially reaching the market sooner than anticipated.

Competition in the obesity field is expected to intensify towards the end of this decade, as many companies have treatments in development expected to launch in the late 2020s.

These promising results could give VK2735 a competitive edge over other candidates in the pipeline.

Assuming VK2735 enters Phase III clinical trials next year, it could become one of the next therapies to enter the market, directly competing with Eli Lilly’s tirzepatide due to its similar MoA.

In addition to the SC version of VK2735, Viking Therapeutics is also developing an oral version of the same molecule, with a Phase II study anticipated to commence in the fourth quarter of 2024.

The company is also exploring a monthly dosing regimen for the SC form, which could provide an advantage over tirzepatide and make VK2735 more appealing to patients.

However, pipeline candidates entering the market will also have to compete against Wegovy, which has been pursuing label extensions in various regions.

In fact, Wegovy has just been approved in the UK and the EU as the first drug to reduce the risk of cardiovascular events in adults with obesity.

It will be interesting to see whether new therapies entering the obesity market will follow Novo Nordisk‘s approach of pursuing label extensions or opt for alternative strategies to enhance their competitiveness.

In conclusion, Viking Therapeutics’ candidate may soon enter Phase III trials, with a head-to-head trial against tirzepatide likely on the horizon.