ProJenX Announces Receipt of $1M Hoffman ALS Clinical Trial Award from the ALS Association

Funding will support the first study of prosetin in people living with ALS

NEW YORK, June 20, 2024 /PRNewswire/ -- ProJenX, Inc., a clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other debilitating brain diseases, today announced the receipt of a $1M Hoffman ALS Clinical Trials Award from the ALS Association. The grant will help fund the development of prosetin, a novel, brain-penetrant, MAP4 kinase (MAP4K) inhibitor, in the Part 1c portion of the PRO-101 clinical trial of prosetin in participants living with ALS.

PRO-101 evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of prosetin. ProJenX has completed the Part 1a and Part 1b portions of PRO-101 in healthy volunteers. Part 1c of the PRO-101 clinical trial is expected to initiate enrollment in Q3 2024.

“We are honored that the ALS Association recognizes the promise of prosetin and has selected ProJenX for a Hoffman Clinical Trial Award,” said Erin Fleming, Co-Founder and Chief Operating Officer at ProJenX. “Their support enables the rapid initiation of the first clinical study of prosetin in individuals living with ALS, which is a significant milestone for prosetin, ProJenX, and the broader ALS community that has supported this program since inception.”

“The ALS Association’s Hoffman Clinical Trial Awards Program supports early-stage clinical trials of new treatments that hold promise for those living with ALS,” said Kuldip Dave, Senior Vice President of Research at the ALS Association. “By funding Part 1c of the PRO-101 trial, we are pleased to support the first dosing of prosetin in people living with ALS. By funding programs at this critical stage, we hope to accelerate the development of therapeutic candidates that can help make ALS a livable disease.”

“Decades of collaborative preclinical research funded by Project ALS at Columbia University pinpointed core mechanisms of ALS and resulted in the development of prosetin to counter ALS pathology across multiple forms of the disease,” said Jinsy Andrews, MD, MSc, clinical advisor to ProJenX and Director of Neuromuscular Clinical Trials at the Columbia University Irving Medical Center. “I am excited to work with ProJenX to initiate Part 1c of the PRO-101 clinical trial, which will evaluate safety across multiple doses of prosetin and also explore biomarkers indicative of prosetin’s potential impact on ALS disease progression.”

About PRO-101

PRO-101 is a three-part phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of prosetin in healthy volunteers and patients with ALS. Parts 1a and 1b, which have been completed, consisted of a randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, and pharmacokinetics of single ascending and multiple doses of prosetin in healthy volunteers. Based on favorable safety, tolerability, and pharmacokinetic data from this portion of the study, Part 1c will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of prosetin in ALS patients. Following the Part 1c, a long-term Open Label Extension (OLE) of 12 or more months will occur, allowing observation of the long-term behavior of prosetin in ALS patients, measured via biomarkers of disease progression, neurodegeneration, and neuroinflammation in plasma. For more information about PRO-101, contact trials@projenx.com.

About the ALS Association

The ALS Association is the largest philanthropic funder of ALS research in the world. The Association funds global research collaborations, assists people with ALS and their families through its nationwide network of care and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association is working to make ALS a livable disease while urgently searching for new treatments and a cure. For more information about The ALS Association, visit our website at als.org.

About ProJenX

ProJenX is a clinical-stage biotechnology company developing novel, brain-penetrant, targeted therapies to address untreatable brain diseases, with an initial focus on ALS. ProJenX was created out of a long-term research collaboration between Project ALS and researchers at Columbia University to rapidly develop and commercialize its lead therapy candidate, prosetin, for people living with ALS. At the heart of ProJenX’s approach is an innovative, patient-specific, cell-based drug discovery platform that can be leveraged for research and drug development for ALS and other debilitating brain diseases. For more information, visit projenx.com.

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