EU Approves ProJenX's Prosetin ALS Clinical Trial

Biotechnology firm ProJenX has obtained approval from the European Union to conduct a Phase 1 clinical trial, known as PRO-101, for prosetin, a groundbreaking MAP4K inhibitor. This follows a similar authorization from Health Canada, broadening the scope of the study to include European participants. The trial aims to assess the safety, tolerability, and pharmacological properties of prosetin in both healthy individuals and those with amyotrophic lateral sclerosis (ALS).
Erin Fleming, ProJenX's Co-Founder and COO, expressed the company's eagerness to begin enrolling ALS patients in the study. Prosetin was developed by ProJenX's founders at Columbia University, with the compound designed to protect motor neurons, a discovery that has significant implications for ALS treatment. The drug candidate has been specifically optimized for its target, with a focus on potency, efficacy in neuron preservation, and enhanced central nervous system distribution.
Leonard H. van den Berg, a neurology professor and chairman of the Treatment Research Initiative to Cure ALS (TRICALS), highlighted the urgent need for treatments to combat the rapid progression of ALS. He noted that MAP4K inhibition has demonstrated the potential to shield motor neurons from stress and other ALS-related pathological processes. The PRO-101 study, he said, marks the first clinical trial to investigate the therapeutic benefits of MAP4K inhibition for ALS patients.
The PRO-101 trial is divided into three parts, with the first two phases already completed. These initial stages involved a placebo-controlled, escalating dose study in healthy volunteers to evaluate prosetin's safety and pharmacokinetics. Encouraging results from these phases have paved the way for Part 1c, which will focus on ALS patients.
ProJenX is dedicated to developing innovative therapies for brain diseases, with a primary focus on ALS. The company was established through a collaboration with Project ALS and Columbia University researchers, with the goal of advancing prosetin as a potential ALS treatment. ProJenX's strategy includes a patient-specific, cell-based drug discovery platform that aids in the research and development of treatments for ALS and other brain diseases.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!