4D Pharma has announced positive topline results from Part A of its Phase I/II clinical trial of MRx-4DP0004, an orally-delivered single strain Live Biotherapeutic being developed for the treatment of asthma.
The Phase I/II trial is a multi-center, double-blind, placebo-controlled study in patients with partly controlled asthma taking long-term medication. The primary endpoint of Part A was to evaluate the safety and tolerability of MRx-4DP0004 with secondary endpoints evaluating clinical activity.
Part A met the primary endpoint and the safety profile of MRx-4DP0004 was comparable to placebo. No serious adverse events (SAEs) related to treatment were reported.
MRx-4DP0004 generated promising signals of clinical activity which support progression into Part B of the study. Part B is expected to enroll up to 90 patients, informed by the clinical signals identified in Part A.
Part A enrolled 34 patients, randomised 1:1 to receive oral MRx-4DP0004 or placebo twice daily for 12 weeks, in addition to their usual maintenance therapy of inhaled corticosteroids (ICS) with or without long-acting beta agonist (LABA). 29 patients were evaluable for secondary endpoints of clinical activity. Part A of the study was not powered for statistical significance.
“The results from Part A of 4D Pharma’s Phase I/II study of MRx-4DP0004 as a treatment for asthma are an important step forward in our development of a new safe oral therapeutic for asthma patients,” said Dr. Alex Stevenson, Chief Scientific Officer of 4D Pharma. “Not only do the results support the excellent safety profile shown to date across our clinical pipeline of Live Biotherapeutics for a variety of indications, but also demonstrate our ability to identify and develop single strain LBPs with potent systemic activity using our MicroRx platform. MRx-4DP0004 has shown encouraging activity in key secondary endpoints of clinical activity, and this data will help to guide the selection of patients for future development of the product.”
“For a study of this size in a relatively mild and heterogeneous population the signals are encouraging and if the effects on ACQ and SABA are maintained in larger numbers of participants and confirmed in later studies then could be clinically meaningful,” said Professor Chris Brightling, NIHR Senior Investigator and Clinical Professor in Respiratory Medicine at the University of Leicester. “Asthma is a heterogeneous disease of numerous clinical phenotypes. Current therapeutic options are not effective in all severe patients and thus there remains a significant unmet need for new treatment options. I look forward to the results of the Part B expansion phase, which will help to further identify an optimal target patient population for future development of MRx-4DP0004.”
More information on the trial is available at www.4dpharmaplc.com.