A broad-target contender for treating NASH in a pipeline of new drugs for metabolic and endocrine disorders.
Viking Therapeutics is developing new drug therapies for metabolic and endocrine disorders. Its pipeline includes its product, coded VK2809, an oral, selective thyroid hormone receptor beta (TRβ) agonist now in a Phase 2b study for treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. Another candidate, VK2735, is an agonist of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for various metabolic disorders, now in a Phase 1 trial. A rare disease candidate, VK0214, a selective TRβ agonist, is in a Phase 1b trial for the adrenomyeloneuropathy (AMN) form of X-linked adrenoleukodystrophy (X-ALD). And VK5211 has completed a Phase 2 trial for hip-fracture recovery.
WHAT’S AT STAKE
A company may live or die in countless ways. Although it is popular to call out dying biopharma companies for clinical failures, they are equally likely to exit the scene for simple business reasons, most commonly mergers and acquisitions. Yet a company might find a second life in the same way. When Ligand sought to divest several of its acquired businesses in 2012, one of them, Metabasis, caught the eye of then-analyst Brian Lian, who decided to embark on a new path, obtaining certain assets of Metabasis and founding the new company he now heads as president and CEO — Viking Therapeutics. Lian began by licensing a single drug from Ligand, and in 2014 licensed four others to launch Viking. “Ligand also agreed to invest $2.5 million in Viking if we went straight to an IPO, skipping all of the usual VC rounds and so on,” he says.
“We then initiated clinical development with a muscle-wasting program and subsequently initiated a liver disease program. Both of those studies generated the best data ever reported in that class of compounds for those indications. Based on those successful trials, we were able to raise around $300 million in equity financing to continue to support the development of the programs.”
Metabolic and endocrine diseases still often defy therapeutic solutions. Viking has taken on one of the most stubborn targets in NASH, where a buildup of liver fat triggers other conditions such as inflammation, liver cell damage, and fibrosis. Although Metabasis was developing the drug for lowering LDL cholesterol, VK2809’s initial trial showed it also affects significant liver fat reduction, which justified another year-long Phase 2b study of the drug in treating NASH, according to Lian. “The approval endpoints are based on NASH resolution. So, if the 12-month biopsy shows success, we will go into a Phase 3 study.”
Lian has a basic argument for why VK2809 can succeed where NASH drugs in many other companies have failed: “The NASH patient population is very heterogenous, including people with diabetes, obesity, metabolic syndrome, or lipid irregularities. A lot of therapies have been developed looking at just a single element, such as inflammation or fibrosis. But our drug activates the thyroid hormone beta receptor in the liver, and it has a very broad range of downstream effects — serving like a master regulator of lipid metabolism. Because elevated liver fat appears to help drive disease onset and progression, reducing it may moderate lipotoxicity.”
Science, but also business, will guide Viking’s destiny. Its “Plan A” is to partner with one or more large companies to commercialize and market its products if approved. But it is also looking at orphan indications for some of them, one example being X-ALD with VK0214, where the company would consider fielding an appropriately small sales team. “We have undisclosed programs that are all internally developed, and those would be future announcements related to our development capabilities,” says Lian. The analyst turned CEO has done his homework. Certainly, he knows the outcomes of Viking’s ongoing trials and the opportunities of the market together will determine its fate.
Employees: 20 Headquarters: San Diego, CA
Finances: $3M Private $27M IPO $325M Subsequent Public Raises
Latest Updates April 2022: Completion of enrollment in Phase 2b trial of lead program VK2809 for NASH expected in 2H22. April 2022: Data from Phase 1b study of VK0214 for X-linked adrenoleukodystrophy expected in 1H23