Business
Viking Therapeutics Announces FDA Has Lifted Clinical Hold on Phase 1b Trial of VK0214 in Patients with X-ALD
Study Enrollment and Dosing to Resume SAN DIEGO, July 19, 2022 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage
About this update from Viking Therapeutics, Inc.
[{"type":"text","content":"Study Enrollment and Dosing to Resume\nSAN DIEGO, July 19, 2022 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that the FDA has lifted the clinical hold placed on the clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD). As a result, the company expects to resume study enrollment in the coming weeks.\n\n \n \n \n \n \n \n\n \nThe FDA lifted the clinical hold following its review of results from an in vivo genotoxicity study that it had requested due to the study being conducted with multiple doses in patients. Viking had planned to conduct this study prior to Phase 2 but accelerated its execution based on FDA's request. The study was completed and the results submitted to the Agency in the second quarter. The results showed no evidence of genotoxicity following exposure to VK0214. The company does not believe that the long-term development timeline for VK0214 has been significantly impacted by the temporary clinical hold.\n\"We look forward to resuming study activities and working to complete patient enrollment as quickly as possible,\" said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. \"We are confident in the overall safety and potential efficacy profile of VK0214 to date, and are eager to continue its advancement as a potential disease modifying treatment for patients with X-ALD.\"\nThe Phase 1b study of VK0214 is designed to enroll patients with the adrenomyeloneuropathy (AMN) form of X-ALD. AMN is the most common form of X-ALD, affecting approximately 50% of patients. The trial is a multi-center, randomized, double-blind, placebo-controlled study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered once-daily over a 28-day dosing period. The study also includes an exploratory assessment of the impact of VK0214 on plasma levels of very long chain fatty acids (VLCFAs), as well as an evaluation of the pharmacokinetics of VK0214 in these patients.\nVK0214 is a novel, orally available small molecule thyroid hormone beta receptor (TRβ) agonist that has been granted orphan drug designation by the FDA for the treatment of X-ALD. Results from...