#United States #Boston #Mediar Therapeutics #MTX-463 #Idiopathic Pulmonary Fibrosis

Mediar Therapeutics Initiates Phase 2 WISPer Trial

Mediar Therapeutics, a pioneering biotechnology company focused on developing groundbreaking therapies to combat fibrosis, announced a significant progression in its research efforts. The company has dosed its first patient in the Phase 2 clinical trial, known as WISPer, evaluating their investigational drug MTX-463 as a potential treatment for idiopathic pulmonary fibrosis (IPF). This condition is notorious for its gradual deterioration of lung function, characterized by an alarming increase in lung tissue scarring, which ultimately restricts airflow and leads to life-threatening situations.

Understanding IPF and Its Challenges

Idiopathic pulmonary fibrosis is a progressive lung disease that has limited treatment options currently available. Patients often experience symptoms such as severe shortness of breath and a persistent dry cough, significantly affecting their quality of life. The alarming truth is that the average life expectancy of an IPF patient post-diagnosis is only three to five years. This amplifies the urgent need for innovative treatments that can effectively address the underlying mechanisms of this dreadful condition.

The WISPer Trial's Objective

Conducted as a randomized, double-blind, placebo-controlled study lasting 24 weeks, the WISPer trial aims to assess the efficacy, safety, and tolerability of MTX-463 among patients diagnosed with IPF. The primary endpoint hinges on the change in Forced Vital Capacity (FVC) — a crucial measure of lung function — from the baseline, evaluated after the 24-week treatment period.

As Dr. Toby Maher, Director of Interstitial Lung Disease at the University of Southern California and the chief investigator for the trial, articulated, "Dosing the first patient in the WISPer trial represents an important step forward in the pursuit of new options to address the urgent needs of individuals living with IPF." This sentiment underscores the broader commitment of researchers and clinicians to explore innovative ways for patients coping with this severely debilitating illness.

MTX-463: A First-in-Class Antibody

MTX-463 is notably a first-in-class human IgG1 antibody designed to target WNT1-inducible signaling pathway protein-1 (WISP1), a key protein linked to fibrosis progression. Through its mechanism, MTX-463 is expected to neutralize the fibrotic signaling mediated by WISP1, as demonstrated in preliminary studies showing its efficacy in reducing fibrosis in various preclinical models.

The successful completion of a Phase 1 trial sets the stage for MTX-463's progression into Phase 2, highlighting its potential role in addressing an unmet epidemiological need. Mediar Therapeutics has also been proactive in forging global licensing agreements, such as their recent collaboration with Lilly, which aims to support further advancements of MTX-463 through the WISPer trial.

Mediar's Broader Commitment to Fibrotic Diseases

In addition to the WISPer trial, Mediar Therapeutics is diligently working on two additional wholly-owned drug candidates, targeting different fibrotic disorders. Notably, MTX-474, another first-in-class human IgG1 antibody set to neutralize EphrinB2 signaling, recently reached a crucial milestone as it completed Phase 1 studies. An impending Phase 2 trial for MTX-474, focused on systemic sclerosis, is anticipated to commence in the latter half of 2025.

Moreover, Mediar is advancing its third novel program, aimed at targeting SMOC2 for renal fibrosis, with plans to nominate a clinical candidate shortly. Such efforts signal Mediar's dedication to innovating treatment strategies across multiple fibrotic diseases, heavily influenced by their strong foundational understanding of the pathophysiological mechanisms underlying fibrosis.

Conclusion: A Hopeful Future

Mediar Therapeutics represents a beacon of hope for those affected by fibrosis, particularly IPF, as it embarks on this new chapter with the MTX-463 trial. The commitment to introducing innovative therapies that could potentially alter the course of disease progression serves as a rallying point for both patients and healthcare professionals engaged in this challenging area of medicine. As the trial unfolds, the outcomes will provide essential insights into the efficacy of MTX-463 and shape future therapeutic strategies in combating the impacts of fibrosis.

For more information about the WISPer trial, visit wispertrial.com.