Viking Therapeutics’ experimental drug VK0214 was hit with a clinical hold from the U.S. FDA after what appears to be miscommunication between the company and the FDA over which stage of testing the drug is in.
The California-based biopharmaceutical firm is currently in the clinical trial phase of developing VK0214, a drug used to treat a rare genetic disorder called X-linked adrenoleukodystrophy (X-ALD). X-ALD causes a breakdown in the protective barriers surrounding brain and nerve cells and can cause death or cause patients to enter a vegetative state. VK0214 is Viking’s answer to this lethal disease. The treatment, which was granted orphan drug designation by the FDA in December 2016, has been shown to demonstrate encouraging responses in patients after phase 1 of clinical trials.
The FDA considers the drug to be a phase 2 trial drug, while Viking asserts that it is a phase 1b drug. As a drug in phase 2 study, the FDA expects that the biopharma company has run the required tests, specifically a rodent genotoxicity study. In order to resume the trial as quickly as possible, Viking will accelerate the required studies in its timeline.
No data from previously submitted or ongoing studies caused the hold, said CEO of Viking, Brian Lian. The company is confident in the safety and efficacy of VK0214 and expects to submit a response with a goal to resume testing later in 2022, he added.
Viking focuses on the development of first-in-class therapies for the treatment of metabolic and endocrine disorders. It currently has several drug candidates in various stages of clinical trials including VK2809, a novel treatment against lipid and metabolic disorders including non-alcoholic steatohepatitis and non-alcoholic fatty liver disease.
The company does not expect the hold to affect long-term development timelines of its drug. Viking expects to have information for the FDA between April and June, the company says.
