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news.The US Food and Drug Administration (FDA) has accepted X-Rx's investigational new drug application (IND) for X-165 being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Image: The US FDA’s Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
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X-165 is a highly potent and selective small molecule inhibitor of Autotaxin owned by X-Rx. An initial advanced lead series that led to the identification of X-165 was discovered directly from the initial screen of over 100 billion molecules using X-Chem, Inc.’s DEXTM DNA encoded library technology. X-165 has demonstrated both promising results in pre-clinical efficacy models of inhibition of lung fibrosis as an orally delivered agent and a safety profile in GLP toxicology studies supporting its advancement into the clinic.
With the IND acceptance, X-Rx plans to initiate soon a randomized, double-blind, placebo-controlled, single and multiple dose escalation Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of oral X-165 in healthy volunteers.
“The upcoming clinical trial marks a major milestone for X-Rx, as X-165 becomes the second to reach the clinic, and the first candidate discovered using X-Chem, Inc.’s DEX DNA encoded library technology,” said X-Rx’s Chief Scientific Officer, Christelle Huguet, PhD. “It is exciting to bring forward an anti-fibrotic therapy which could add to current standard of care in a number of conditions, like IPF, where the unmet medical need is high and fibrosis is a key component of the pathophysiology.”
Source: Company Press Release
