Viking's obesity drug advancing to phase 3 with $300M for trials

Viking Therapeutics is accelerating its plans to advance its obesity drug VK2735 into phase 3 trials, with the clinical program estimated to exceed $300 million. Having gained significant attention earlier this year due to promising weight loss data, the company has received approval from the FDA to initiate the planning for these late-stage trials.

CEO Brian Lian, Ph.D., addressed investors, revealing that Viking had presented the results from the phase 2 VENTURE trial to the FDA. The feedback received has given the green light to move forward with the crucial phase 3 study. However, specific details about the trial’s design remain under wraps, as further guidance from the FDA is still awaited. The primary aim of their initial discussions was to confirm the readiness to proceed into phase 3 trials.

The next steps involve scheduling an end-of-phase 2 meeting with the FDA to review development plans, anticipated to occur in the fourth quarter. Lian disclosed that the FDA's guidance necessitates two phase 3 studies involving a minimum of 4,500 participants, with at least 3,000 receiving VK2735. The overall design strategy will align with this guidance.

Chief Financial Officer Greg Zante anticipates that the phase 3 program for subcutaneous VK2735 will cost around $300 million. This figure does not account for additional outcomes studies, such as those focusing on cardiovascular benefits, which are being explored by larger pharmaceutical companies like Eli Lilly and Novo Nordisk. These companies are leading the way in demonstrating the comprehensive health benefits of GLP-1 therapies. For instance, Novo Nordisk recently secured FDA approval for Wegovy to reduce cardiovascular risks in obese adults, while Eli Lilly is seeking approval for Zepbound in sleep apnea.

The scale at which major pharmaceutical companies can conduct extensive clinical programs highlights the challenges faced by smaller biotechs like Viking. Nevertheless, Viking has a potential advantage: exploring whether VK2735 can be administered monthly, which could be more convenient than the current weekly injections. Lian believes that offering both weekly and monthly dosing options would be beneficial for patients, allowing them to choose based on their lifestyle and preferences.

Additionally, Viking is advancing the oral tablet formulation of VK2735. Earlier this year, the candidate moved to phase 2 trials after demonstrating weight loss of 5% or more within 28 days of dosing. Lian envisions a scenario where patients initially use the injectable form of VK2735 and later switch to the oral version to maintain their weight loss, thus avoiding the need to transition to a new medication.

Viking has filed an investigational new drug application with the FDA to begin phase 1 studies of the oral VK2735 in the U.S., which should expedite the study’s progress. With the application approved, Viking has completed dose escalation for patients taking 60 mg or 80 mg daily, with a 100-mg group currently ongoing. Early data from the phase 1 trial supports moving into a larger phase 2 test, planned to commence in the fourth quarter.

Being a smaller biotech, Viking faces questions about whether it will continue independently or seek partnerships, especially considering interest from larger pharmaceutical companies. Lian confirmed that partnering could be an option, though he remained tight-lipped about any ongoing or previous discussions. For now, Viking is well-capitalized to pursue its development programs, with cash and equivalents of $942 million as of June 30.

Beyond VK2735, Viking is also developing VK2809 for metabolic dysfunction-associated steatohepatitis (MASH), VK0214 for X-linked adrenoleukodystrophy (X-ALD), and other early-stage weight loss programs. Analysts from William Blair expect Viking’s cash reserves to support the company for over three years, covering various development milestones, including phase 3 results for subcutaneous VK2735 and phase 2 results for its oral formulation.

Lian expressed confidence in the company’s ability to advance these programs aggressively, particularly the obesity program. For the MASH program, Viking plans to seek feedback from an end-of-phase 2 meeting to understand current registration paths, with a preference for partnering the program for registrational tests.

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