WALTHAM, Mass.--(BUSINESS WIRE)--X-Rx, Inc., a privately held biotechnology company focused on applying its innovative drug development capabilities to the generation of novel small molecule therapeutics, today announced the US Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug Application (IND) for X-165 being developed for the treatment of Idiopathic Pulmonary Fibrosis.
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.”
IPF is a chronic, progressive fibrotic disorder of the lungs that typically affects adults over the age of 40. With approximately 200,000 patients with IPF in the United States and Europe, and 75,000 newly diagnosed patients per year, IPF is considered a rare disease. Currently, no medical therapies have been found to cure IPF and current standard of care aims to slow disease progression and improve the quality of life. While the regulatory approval of current therapies, Esbriet® (pirfenidone) and Ofev® (nintedanib), represent important developments for IPF patients, neither drug improves lung function and the disease continues to progress in the majority of patients despite treatment. As a result, there remains a large unmet medical, as IPF is a major cause of morbidity and mortality.
X-Rx is a clinical stage biotechnology company that discovers and develops small molecule medicines in inflammation, fibrosis, and oncology. X-Rx was spun out of X-Chem, Inc. in 2012, and since then it has developed a BTK inhibitor in clinical development with an undisclosed partner, along with X-165, an IND approved small molecule inhibitor of autotaxin for the treatment of IPF and other fibrotic indications.