SAN DIEGO – Viking Therapeutics – like the historic brigands it is named after – has set its sights on raiding and plundering the obesity drug market, currently dominated by pharma heavyweights Eli Lilly and Novo Nordisk.
Last month, the San Diego-based Viking (Nasdaq: VKTX) announced plans to advance its injectable weight loss drug VK2735 into a Phase 3 clinical trial, flowing a successful Phase 2 study demonstrating “up to an approximately 15% reduction in body weight from baseline following 13 weeks of dosing, as well as promising safety and tolerability,” said Viking CEO Brian Lian, Ph.D.
The initiation of a Phase 3 study of VK2735 was prompted by feedback from the FDA after Viking announced the positive top-line results of the Phase 2 trial released in February of this year. Viking is preparing for an end of Phase 2 meeting with FDA, expected to occur later this year, the company reported.
In addition to positive results from the Phase 2 study of the injectable VK2735, Viking also reported positive results of a Phase 1 study of an oral tablet formulation of VK2735. The company expects to begin a Phase 2 study of the oral drug later this year.
Founder, President & CEO
Viking Therapeutics
In June, Viking also reported “promising in vivo data from a novel series of internally developed amylin agonists,” Lian said. Amylin agonists are also injectable drugs used to treat diabetes and can lead to weight loss. Viking expects to file and investigational new drug application to the FDA for the program sometime in 2025
Breaking Into the Big Leagues
Viking’s VK2735 is a glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) drug – a relatively new class of medications that treat type 2 diabetes and obesity by inhibiting the pancreas from releasing glucagon after a meal, especially if blood sugar levels are high. GLP-1 agonists can also lead to reduced food intake by making people feel fuller and lowering their desire for certain foods that lead to weight gain.
According to a Morgan Stanley research report released in May of this year, the global market for obesity drugs is expected to reach between $105 billion and $144 billion by 2030. Sales of obesity drugs were just $6 billion in 2023, according to the report.
Currently, there are nearly a dozen approved GLP-1s on the market, most manufactured by Eli Lilly or Novo Nordisk and a few made by AstraZeneca. In March of this year, GlobalData predicted that GLP-1 drugs made by Novo Nordisk and Eli Lilly would account for 83% of the obesity drug market by 2029.
That prediction may need to be updated if patients react to Viking’s injectable weight loss drug the same way investors reacted to the company’s announcements about VK2735’s Phase 2 results and its advancement into Phase 3.
When Viking announced the results from the Phase 2 study in February, shares of VKTX shot up 150% on the news. Last month, when the company announced it would be initiating Phase 3 earlier than expected, shares jumped by about 28%. Year to date, VKTX shares are up nearly 175%.
More Successful Programs
Viking’s positive results for its drugs it is developing in the red-hot obesity market isn’t the company’s only successes this year.
In addition to its obesity drug programs, Viking this year “reported best-in-class histology data” from its Phase 2b study of VK2809 – a thyroid hormone beta receptor agonist medication to treat liver fibrosis from non-alcoholic steatohepatitis (NASH), Lian said, adding that the company plans “to schedule an end of Phase 2 meeting with the FDA later this year.
Viking is also gearing up for a Phase 1b study of a second thyroid hormone beta receptor agonist, VK0214, to treat X-linked adrenoleukodystrophy – a genetic disorder that mainly affects the nervous system and adrenal glands. That study is currently enrolled, and results are expected later this year.
Viking Therapeutics
FOUNDED: 2012
HEADQUARTERS: San Diego
CEO: Brian Lian, Ph.D.
BUSINESS: clinical-stage biopharmaceutical company
STOCK: VKTX (Nasdaq)
REVENUE: Pre-revenue, but the company reported in its July 27 Q2 report it had $942 million in cash.
EMPLOYEES: ~30
WEBSITE: www.vikingtherapeutics.com
NOTABLE: Year to date, shares of VKTX are up ~175%
