Cheshire-based Redx Pharma announced that the Partial Clinical Hold (PCH) placed on its zelasudil (RXC007) Phase 2a trial in Idiopathic Pulmonary Fibrosis (IPF) by the Division of Pulmonology, Allergy, and Critical Care (DPACC) of the US Food and Drug Administration (FDA) has been lifted.

Redx Pharma’s biggest shareholder is San Francisco investment firm Redmile Group LLC.

“The PCH was issued as a result of a non-clinical observation and limited the dosing period to 28-days in the US during the initial Phase 2a study,” said Redx.

“Following the submission of the final 12-week data, and additional 12-week open label extension (OLE) data from the completed Phase 2a study (RXC007 / 0002) undertaken at 31 sites across Europe and the UK, the FDA have lifted the PCH resulting in an open IND in the US to support the further clinical development of zelasudil.”

Redx Pharma CEO Lisa Anson said: “We are thrilled with the decision of the FDA to lift the partial clinical hold placed on zelasudil following the review of our clinical data package.

“This will allow the next stage of clinical development for zelasudil to take place on a global scale. In addition to our signal in IPF patients, our pre-clinical work has shown zelasudil to have utility across a number of fibrotic diseases and we are focused on bringing this exciting new therapeutic treatment option to patients.“

Redx Pharma added: “Zelasudil is a potential best-in-class potent, highly selective and orally-active inhibitor that targets Rho-Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) which sits at a nodal point in cell signalling pathways, central to fibrosis. 

“Redx are developing zelasudil as a potential treatment for IPF and other interstitial lung diseases, as well as other conditions including Metabolic dysfunction-associated steatohepatitis (MASH) and cancer-associated fibrosis, where the Company has generated supportive pre-clinical data.”