FDA accepts X-Rx new drug application for IPD drug X-165

US biotech company X-Rx said that the US Food and Drug Administration (FDA) has accepted its investigational new drug application (IND) for X-165, a small molecule inhibitor of Autotaxin X-165, which is being developed as a new drug for Idiopathic Pulmonary Fibrosis.

According to X-Rx, X-165 as an orally delivered agent, has shown promising results in pre-clinical efficacy models of inhibition of lung fibrosis. The drug candidate has also demonstrated a safety profile in GLP toxicology studies that support its progress to clinical development.

X-Rx said that following the IND acceptance, it will initiate shortly a randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 trial designed to evaluate the safety, tolerability and pharmacokinetics of X-165 in healthy volunteers.

Christelle Huguet – X-Rx Chief Scientific Officer said: “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.

“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.”

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