In the early hours of Monday, Viking Therapeutics stock went up 21% after the biotech company released data from a Phase 1 study of its oral weight-loss drug that showed better-than-expected results.
The adults who were obese and took the biggest dose of VK2735 (100 milligrammes) lost an average of 8.2% of their body weight over the course of four weeks. Compared to the placebo, the 100 mg amount also caused up to 6.8% weight loss.
The information was shared during Obesity Week, which is being held in San Antonio, Texas, from November 3rd to 6th and is put on by the Obesity Society. Viking VKTX 0.47% also showed information about the injectable form of VK2735 that is now being tried in a Phase 2 trial.
But the oral treatment is what the company is really buzzing about. It was well tolerated up to a 100 mg dose, and most of the side effects were found to be mild to moderate.
The 8% weight loss at the highest dose was noticed by experts at JPMorgan. This is more than any of the other oral drugs that are being developed by competitors. Analysts led by Hardik Parikh said it was a “great outcome” and said it was impressive how well the higher doses were tolerated.
The weight loss results lasted until Day 57, which was up to 8.3% from the starting point and four weeks after the last dose was given.
Viking said it thinks that continuing treatment for more than 28 days might help people lose even more weight.
As planned, Viking CEO Brian Lian said, “The updated oral Phase 1 study results continue to demonstrate an encouraging tolerability profile and promising signs of clinical activity at doses of up to 100 mg daily.” “We think that the long-lasting effects seen after 28 days of dosing suggest that lower dose regimens might be possible after the initial weight loss induction.”
The stock has been on a tear this year, rising almost 300% so far in 2024. It is in the unique situation of having all buy ratings from the 13 analysts who follow it on FactSet.
Novo Nordisk (NOVO.B -0.98%) and Eli Lilly (LLY -1.30%) made the GLP-1 class of drugs more well-known. VK2735 is one of these drugs, but other drugs on the market have to be shot instead of being taken by mouth.
An oral form would likely be a big deal for whichever company comes up with it first, since it would be easier to give and might appeal to people who are afraid of needles.
The Phase 1 study showed that the oral version worked well. After 28 days, people who took a 40-milligram dose lost 3.3% of their body weight compared to those who took a placebo. In its update, the company gave information on the higher dose ranges of 60 mg and 80 mg, as well as the highest amount of 100 mg.
The results did not disappoint, according to Stifel. They showed that oral VK2735 (peptide) had “best-in-class” efficacy at the highest dose while also being very well tolerated and having long-lasting effects after treatment. This made it possible to try different regimens in the important post-treatment setting.
Based on weight loss that lasted seven weeks after treatment, the injectable version showed clear potential for a once-monthly dose. This was called “another ideal option for maintenance” by Stifel analysts led by Annabel Samimy in a note to clients.
Viking said that data showed the drug’s PK profile, which stands for pharmacokinetics and measures how the body reacts to drugs over the course of exposure, supported a dose of once a month.
The Stifel analysts wrote, “Both oral and injectable VK2735 continues to boast one of the most competitive profiles in the obesity space, with strong efficacy and tolerability and now a potential for versatile monthly dosing for maintenance therapy.”
Viking said it would meet with the Food and Drug Administration later this quarter to talk about the next steps in clinical development for the injectable version of VK2735. By the end of the year, a Phase 2 study of the pill version should also be underway.
Information about how the study will be set up will be given closer to the start of the trial.
As with Novo Nordisk’s Wegovy and Ozempic and Lilly’s Mounjaro, Viking’s injectable and oral treatments work by imitating the effects of GLP-1, a hormone in the gut that can help control blood sugar levels and make people feel less hungry. A glucagon-like peptide is what GLP stands for.
