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Viking (VKTX) Study on X-ALD Put on Clinical Hold by the FDA

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Viking Therapeutics, Inc. (VKTX - Free Report) recently received a setback as the FDA placed a clinical hold on its early-stage study of pipeline candidate VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD).

The regulatory body has requested an additional preclinical study prior to continue the phase Ib study of VK0214 in X-ALD. The request was not due to any findings from ongoing or previously completed studies.

The FDA considers the ongoing trial a phase II study rather than a phase Ib. The company stated that a rodent genotoxicity study is required before the continuation of the phase II study.

Viking expects to provide the information to the FDA in the second quarter.

Viking had earlier planned to conduct this study prior to phase II but will now accelerate its execution. The company does not expect the long-term development timeline for VK0214 to be significantly impacted, even though a short-term delay is expected.

VK0214 is a novel, orally available small molecule TRβ agonist. It enjoys orphan drug status in the United States for the treatment of X-ALD.

X-ALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells, a process known as demyelination.  There are no approved treatments for the same.

The lead candidate in the pipeline is VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. It is currently being evaluated in a phase IIb study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis.

The third candidate in the pipeline is VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. VK2735 is currently being evaluated in a phase I study.

The company obtained exclusive worldwide rights to VK2809, VK0214 and VK5211 programs and certain other assets pursuant to an exclusive license agreement with Ligand Pharmaceuticals Incorporated (LGND - Free Report) .

As of Sep 30, 2021, Ligand and its affiliates beneficially owned approximately 8.6% of Viking’s outstanding common stock.

The successful development of any of these candidates will be a significant boost for this clinical-stage company, and any setbacks will adversely impact the share price.

While the NASH market promises potential, it is pretty challenging as well. Quite a few companies are trying to develop drugs for this serious progressive liver disease caused by excessive fat accumulation in the organ that induces chronic inflammation, resulting in progressive fibrosis (scarring) leading to cirrhosis, eventual liver failure, cancer and death.

Intercept Pharmaceuticals, Inc. (ICPT - Free Report) is developing obeticholic acid (OCA) for the treatment of liver fibrosis due to NASH. However, the company is facing several challenges.

Intercept has received a complete response letter (CRL) from the FDA for its new drug application (NDA) for OCA for the treatment of liver fibrosis due to NASH.