Nothing is certain in clinical trials, but investors have reason to expect a better outcome in the oral VK2735 trials.
Nothing is certain in clinical trials, but investors have reason to expect a better outcome in the oral VK2735 trials.
Biopharmaceutical company trial results are full of uncertainty; just ask Viking Therapeutics (VKTX -0.48%) investors, who have been on a bit of a roller-coaster ride with the company's key weight loss drug, VK2735, in its oral formulation. Still, the latest announcement of the initiation of two phase 3 trials creates a lot of promise for investors. Here's why.
Viking Therapeutics and VK2735
As a reminder, Viking already has the weight loss drug in two phase 3 trials in subcutaneous (injectable) form, namely for obesity (VANQUISH-1) and adults with type 2 diabetes who have obesity or are overweight (VANQUISH-2). It's also undergoing a smaller maintenance trial to test a combination of an initial subcutaneous VK2735 dose followed by an oral VK2735 maintenance dose, following a successful maintenance trial using subcutaneous VK2735 as the maintenance dose.
The development of subcutaneous and oral formulations of VK2735 is part of Viking's dual-formulation strategy. That's why it recently announced the initiation of phase 3 trials for oral VK2735 for obesity (SUNRISE-1) and adults with type 2 diabetes with obesity or weight issues (SUNRISE-2)
Viking Therapeutics and oral VK2735
As with all oral medications, there are concerns about safety and tolerability. As such, investors were delighted with the exemplary tolerability data coming from the phase 1 oral VK2735 trial (MAD) in 2024. The 28-day MAD trial involved 37 treated patients, of whom "mild nausea was reported in five (14%) VK2735-treated subjects," with no vomiting, and only one reporting diarrhea. According to the press release, "no clinically meaningful differences were reported for GI-related adverse events among subjects treated with VK2735 compared with placebo."
While phase 1 trials tend to be small, tolerability is generally excellent. That's why investors were shocked by the safety and tolerability results from the phase 2 oral VK2735 (VENTURE-Oral) trial.
In common with MAD, the 13-week VENTURE-Oral showed good efficacy, but unfortunately, it had a 20% discontinuation rate due to adverse events among treated participants. The result caused the stock to crash.
$25.05-$0.12 (-0.48%)
Averytin News Financial update.