Viking Therapeutics is set to present updated data on its oral weight-loss therapy, VK2735, at the upcoming Obesity Week event in San Antonio, Texas. The company's stock has seen significant gains this year, driven by promising early results from Phase 1 trials of the oral drug. Investors and analysts are keenly awaiting data on higher doses and the potential for Phase 2 trials.
Promising Phase 1 Results
Data from the ongoing Phase 1 trial of VK2735 have already shown encouraging results. Participants receiving a 40-milligram dose of the oral therapy experienced a 3.3% placebo-adjusted weight loss after 28 days. Importantly, the drug was reported to be safe and well-tolerated, with no incidence of vomiting or diarrhea, common side effects associated with other weight-loss treatments. This favorable safety profile has raised hopes that higher doses may prove even more effective.
Anticipation for Obesity Week
Viking Therapeutics is expected to present data from the higher dosing arms (60, 80, and 100 milligrams) of the oral VK2735 at Obesity Week. The company will also present data on the injectable version of VK2735, which is currently being evaluated in a Phase 2 trial. Analysts are optimistic that the data will support the advancement of both the oral and injectable formulations into Phase 2 trials.
Jefferies analysts, led by Roger Song, stated in a note to clients that they believe the results will "support the development plan further, including monthly subcutaneous into Phase 2 and oral higher dose into Phase 2, while solidifying the company's class leading position (clinical profile and development timeline) among new-gen peptide incretins."
The Race for an Oral Weight-Loss Pill
The development of an effective oral weight-loss pill is considered a significant advancement in obesity treatment, offering a more convenient alternative to injectable therapies. Several companies, including Novo Nordisk and Eli Lilly & Co., are actively pursuing oral weight-loss medications. Viking's VK2735 utilizes the same mechanism as Novo Nordisk's Wegovy and Ozempic, and Lilly's Mounjaro, mimicking the effects of GLP-1, a gut hormone that regulates blood sugar and reduces appetite.
Scalability and Potential Acquisition
Despite the promising clinical results, scalability remains a key consideration for VK2735. Cantor analysts, led by Prakhar Agrawal, highlighted concerns about the feasibility of producing large quantities of the drug at higher doses. They noted that Novo Nordisk has yet to launch an oral version of semaglutide, despite positive Phase 3 trial results, suggesting potential challenges in scaling up production of peptide drugs at doses above 50 mg per day.
The scalability issue has also fueled speculation that Viking Therapeutics could become a takeover target for a larger pharmaceutical company seeking to expand its portfolio of weight-loss treatments. Jefferies analysts estimate that VK2735 could generate peak U.S. revenues of approximately $12 billion.
Jefferies also anticipates Viking to present data supporting a once-monthly dosing regimen based on the treatment's pharmacokinetic profile. This could further enhance the drug's appeal and convenience for patients.
