US-based biotech company X-Rx has received a major boost in its quest to develop new treatments for Idiopathic Pulmonary Fibrosis (IPF) with the US Food and Drug Administration (FDA) accepting its Investigational New Drug (IND) application for X-165, an innovative small molecule inhibitor of Autotaxin. This approval opens the door to clinical trials for X-165, a promising candidate in the race to combat IPF, a debilitating lung disease with limited treatment options.

X-165, which is an orally delivered agent, has shown strong preclinical efficacy in models designed to inhibit lung fibrosis. These encouraging results highlight the drug’s potential in slowing the progression of IPF. Additionally, X-165 has passed key safety evaluations in Good Laboratory Practice (GLP) toxicology studies, indicating that it is ready for the next stage of clinical development.

A significant milestone for X-Rx

With the IND acceptance, X-Rx is now poised to launch a randomized, double-blind, placebo-controlled, single and multiple dose escalation Phase 1 clinical trial. This trial will focus on assessing the safety, tolerability, and pharmacokinetics of X-165 in healthy volunteers. The Phase 1 study is set to be a crucial step in advancing the drug towards broader clinical testing, with the ultimate aim of treating patients with IPF and other fibrotic diseases.

Expert insights on X-165’s potential

Christelle Huguet, Chief Scientific Officer at X-Rx, expressed enthusiasm over the IND acceptance, noting that this marks a significant milestone for the company. X-165 becomes the second drug to reach the clinic from X-Rx’s pipeline and the first to emerge from its collaboration with X-Chem, Inc. using their DEX DNA-encoded library technology. Huguet highlighted the importance of this achievement, noting that IPF remains an area with a high unmet medical need, and the potential addition of X-165 to existing treatment regimens could provide a much-needed new approach to managing the disease.

With its promising preclinical data, X-165 has garnered attention as a potential anti-fibrotic therapy. It is positioned to fill a critical gap in the current treatment landscape, where fibrosis plays a key role in the progression of several diseases, including IPF.

As X-Rx moves forward with its clinical trial, the biotech company is on track to redefine the treatment paradigm for fibrotic diseases, positioning X-165 as a new hope for patients suffering from conditions with few therapeutic options.

  Autotaxin, Christelle Huguet, FDA, GLP toxicology, Idiopathic pulmonary fibrosis, Investigational New Drug, IPF, Phase 1 trial, X-165, X-Chem, X-Rx