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Viking Therapeutics Announces Initiation of Phase 1b Clinical Trial of VK0214 in Patients with X-ALD
Novel, Selective Thyroid Receptor Beta Agonist Being Evaluated in X-ALD Patients Following Successful Completion of Phase 1 Healthy Volunteer Study SAN DIEGO,
About this update from Viking Therapeutics, Inc.
[{"type":"text","content":"Novel, Selective Thyroid Receptor Beta Agonist Being Evaluated in X-ALD Patients Following Successful Completion of Phase 1 Healthy Volunteer Study\n\n\nSAN DIEGO, June 24, 2021 /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 the initiation of a Phase 1b clinical trial of VK0214, a novel small molecule agonist of the thyroid hormone receptor beta (TRβ), in patients with X-linked adrenoleukodystrophy (X-ALD). The study is open to enrollment at clinical sites within the United States.\n\n \n \n \n \n \n \n\n \nThe Phase 1b trial is a multi-center, randomized, double-blind, placebo-controlled study in adult male patients with the adrenomyeloneuropathy (AMN) form of X-ALD. The study is initially targeting enrollment across three cohorts: placebo, VK0214 20 mg daily, and VK0214 40 mg daily. Pending a blinded review of preliminary safety, tolerability, and pharmacokinetic data, additional dosing cohorts may be pursued.\n\n The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered once-daily over a 28-day dosing period, and to assess the efficacy of VK0214 at lowering plasma levels of very long chain fatty acids (VLCFAs) in patients with AMN. Secondary objectives include an evaluation of the pharmacokinetics and pharmacodynamics of VK0214 following 28 days of dosing in this population.\n\n VK0214 is a novel, orally available small molecule TRβ agonist that recently completed a successful Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy subjects. Results from that trial showed that VK0214 demonstrated encouraging safety and tolerability, as well as predictable pharmacokinetics. In addition, subjects who received VK0214 experienced reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and apolipoprotein B following 14 days of treatment. Based on these results, VK0214 was advanced into the Phase 1b study in patients with AMN.\n\n \"We are excited to initiate a proof-of-concept study with our second thyroid agonist, VK0214, and look forward to evaluating its therapeutic potential in setting of adrenomyeloneuropathy. The results of our recently completed Phase 1 trial demonstrate...