ProJenX Announces Formation of Clinical Advisory Board

NEW YORK, Aug. 27, 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 neurodegenerative diseases, today announced the formation of its Clinical Advisory Board (ClAB). The ClAB, which includes internationally renowned experts in clinical trial strategy and design for ALS and related neurodegenerative diseases, will provide strategic guidance for the clinical development of ProJenX's lead therapeutic candidate, prosetin—a novel, brain-penetrant, MAP4 kinase (MAP4K) inhibitor—and additional pipeline programs.

Prosetin is being evaluated in Study PRO-101, a hybrid Phase 1 clinical trial designed to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and participants with ALS. Parts A and B of the study, which assessed single and multiple ascending doses of prosetin in healthy volunteers, are complete, and positive safety, tolerability, and pharmacokinetic data from 48 healthy volunteers supports continued exploration of prosetin in ALS participants.

The inaugural ClAB Chair is Angela Genge, MD, FRCP(C), eMBA (McGill University), who is joined by members Jinsy Andrews, MD, MSc (Columbia University), Leonard van den Berg, MD, PhD (UMC Utrecht), and Merit Cudkowicz, MD, MSc (Massachusetts General Hospital).

Dr. Genge, Director of the ALS Global Centre of Excellence at the Montreal Neurological Institute and Professor of Neurology at McGill University, said, "Improved clinical outcomes for ALS patients will only be achieved through stewarding novel, scientifically rational investigational therapies supported by compelling and thorough preclinical data into the ALS clinical trial pipeline. Prosetin has been developed specifically for ALS and demonstrates robust neuroprotection in diverse ALS patient-derived stem cell models of the disease, and I am excited to guide Study PRO-101 as Chair of the ProJenX Clinical Advisory Board, as well as Principal Investigator of one of the trial study sites."

Erin Fleming, Co-Founder and Chief Operating Officer at ProJenX, said, "As we initiate the first-ever clinical study of prosetin in people living with ALS, we are thrilled to convene a world-class Clinical Advisory Board, which will bring unrivaled experience and knowledge across ALS drug development and data-driven clinical trial design to the prosetin development program. With our advisors' leadership, ProJenX is poised to translate decades of scientific discovery to people with ALS."

ProJenX's ClAB member biographies can be viewed here.

About ProJenX

ProJenX is a clinical-stage biotechnology company developing novel, brain-penetrant, targeted therapies to address neurodegenerative 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.

About Prosetin

Prosetin is a potent, oral, brain-penetrant, mitogen-activated protein kinase (MAP4K) inhibitor targeting endoplasmic reticulum (ER) stress. ER stress is a common feature across sporadic and familial forms of ALS, and MAP4Ks emerged as the critical regulators of ER stress-mediated motor neuron loss in a patient-specific, cell-based discovery platform developed by researchers at Columbia University. ProJenX is currently conducting a three-part Phase 1 clinical trial, PRO-101, investigating prosetin in healthy individuals and people living with ALS. Prosetin is an investigational new drug and has not been approved by the FDA.

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SOURCE ProJenX