Following an end-of-Phase II meeting with the FDA in the fourth quarter, Viking Therapeutics plans to push its subcutaneous obesity therapy VK2735 into late-stage development and to start a Phase II trial for an oral formulation.
Viking Therapeutics on Wednesday unveiled plans to ramp up the development of its investigational obesity therapy VK2735, with two key upcoming events in the fourth quarter of 2024.
Prior to the end of the year, the company expects an end-of-Phase II meeting with the FDA for its subcutaneous formulation of VK2735, after which it plans to push the drug candidate into late-stage development for obesity. Viking will reveal more details about the Phase III program’s design and timeline after the regulatory meeting.
Also in Q4, Viking will start its Phase II trial for the oral formulation of VK2735, which it is advancing alongside the more mature subcutaneous version. Specifics of the mid-stage study were sparse, with the company only revealing that it will run for 13 weeks. Viking CEO Brian Lian in an investor call on Wednesday promised to provide more details regarding the study’s design “as we get closer to trial initiation.”
“We are proud of the clinical progress we’ve made this year,” Lian said during the call, referring to the strong data the biotech has generated for VK2735.
In Q1, Viking released a topline readout for the Phase II VENTURE study, touting a 9.1% drop in body weight at 13 weeks in patients treated with the 2.5-mg subcutaneous VK-2735. Placebo counterparts, on the other hand, lost only 1.7% of their body weight at this time point. At a 15-mg dose, VK-2735 elicited nearly 15% weight loss.
A month later, Viking also announced that oral VK2735 at a 40-mg dose resulted in a 3.3% reduction in mean body weight versus placebo, an effect that was statistically significant.
“The first three quarters of 2024 have been data-rich for Viking,” Lian said, noting that aside from its promising efficacy, VK2735 also has a strong safety profile. Most treatment-emergent adverse events were mild or moderate and arose early in the treatment course. A majority of the side effects were gastrointestinal in nature, which is common for the GLP-1 drug class.
Analysts were positive about Viking’s update on Wednesday. Truist Securities analyst Joon Lee in an investor note said that oral VK2735 “could be the best oral GLP1 yet, on efficacy and tolerability,” noting that the company’s VK2735 franchise appears to have an “excellent safety profile,” especially since even a 100-mg dose of the oral formulation did not trigger a stop signal from an independent data monitoring committee.
Given the pharmacokinetic profile of subcutaneous VK2735, Viking is also exploring a monthly dosing regimen for the therapy, which William Blair analyst Andy Hsieh wrote in an investor note “could provide a key differentiator from competitive programs,” particularly given ongoing concerns about supply and production.
Viking also released Q3 results on Wednesday, reporting a net loss of nearly $25 million, driven by more aggressive R&D activities in the quarter. Still, the company expects to have enough money to fund the development of its programs, especially VK2735.
“With $930 million in cash and equivalents at the end of the third quarter, we believe we have the financial resources required to reach key clinical milestones for each of our programs, and we look forward to reporting further progress in the quarters ahead,” Lian said.
