Pharmaceutical Business review

FDA accepts X-Rx’s IND application for X-165 to treat IPF

Image: The US FDA’s Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

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