Viking Therapeutics is rowing its longboat toward the front of the oral obesity therapy race, posting detailed phase 1 data that suggest its dual agonist of GLP-1 and GIP can hold its own in a crowded field.
The biotech had tested the oral asset, dubbed VK2735, at doses ranging from 2.5 mg up to 100 mg. Viking already revealed back in March that 25% of the eight patients who received 20-mg doses saw their body weight fall by 5% or more after 28 days, with the number rising to 57% in the seven patients who received the 40-mg doses.
In a Sunday poster presentation at the ObesityWeek conference in San Antonio, Viking finally laid out the long-awaited 28-day weight loss data across the various doses trialed. While the lowest doses failed to beat placebo, the 20-mg dose was tied to a 2.2% placebo-adjusted mean weight reduction, with a 3.7% weight loss linked to the 40-mg dose, a 2.7% loss for the 60-mg dose, a 3.9% loss for 80-mg dose and 6.8% for the 100-mg dose.
“Based on a preliminary evaluation of weight loss trajectories at multiple dose levels, the company believes that continued treatment beyond 28 days may provide further reductions in body weight,” Viking added in an accompanying press release this morning.
William Blair analysts said they had been hoping for weight loss in the range of 5% to 6% for the highest dose, which would have been in line with the 5% seen by Novo Nordisk’s own oral obesity contender amycretin. Unlike VK2735, which is a dual agonist of the glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptors, Novo’s amycretin is a dual agonist of GLP-1 and the amylin receptor.
The 6.8% weight loss achieved by VK2735 meant Viking's candidate appeared to have “outmaneuvered” amycretin, the analysts suggested.
The vast majority, 99%, of treatment-emergent adverse events in the phase 1 trial were mild or moderate, Viking said. All the gastrointestinal adverse events were also mild or moderate, the company pointed out, while mild nausea was reported in 32% of VK2735-treated patients compared with 11% in the placebo cohort. William Blair analysts described this as a “highly benign tolerability profile.”
Viking also used the ObesityWeek conference to unveil further data for its injectable version of VK2735. The biotech already began preparations for a phase 3 trial on the back of a midstage study’s readout that the highest, 15-mg, dose of the injectable was linked to mean weight loss of 14.7% after 13 weeks of treatment.
Yesterday’s presentation showed a placebo-adjusted mean weight loss from baseline of 7.4% for the 2.5-mg dose, 9.2% for 5 mg, 11.3% for 10 mg and 13.1% for 15 mg.
Viking plans to discuss “the clinical path forward for injectable VK2735 later this quarter,” with a phase 2 study of the oral version set to kick off before the end of the year, Viking CEO Brian Lian, Ph.D., said in a statement Monday.
The company’s stock initially bumped up 18% in premarket trading Monday to $85.82 from a Friday closing price of $72.88 on the back of the latest readouts. It continues an upward trajectory for the San Diego-based biotech’s stock, which started the year below $20.
While the company would now likely command a hefty price, William Blair analysts said in their note this morning that the likelihood of a buyout is “reasonably high.”
“From a competitive advantage perspective, VK2735’s status as a phase 3-ready asset, coupled with the ability to formulate into an oral route of administration (tablet formulation), along with an amylin program that is on track to enter phase 1 development next year, offers a unique set of attractive characteristics in the lens of Big Pharma,” they added.
As well as Novo, Viking’s oral program is progressing in an increasingly crowded space also occupied by the likes of Eli Lilly, Pfizer, Roche and Terns Pharmaceuticals.