Participated · Series A · Jun 2020

Prilenia is advancing pridopidine, a Sigma‑1 receptor agonist, as a potential treatment for Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS). The company has completed enrollment in the global PROOF‑HD Phase 3 trial and is participating in the HEALEY ALS Platform Trial. Pridopidine received Fast Track designation for HD, which may enable more frequent FDA interactions and potential eligibility for accelerated approval and priority review. Proceeds from a recent $10 million second closing of its Series B will support clinical development through 2024. Data readouts from the HEALEY ALS Platform Trial and PROOF‑HD are expected within the next 12 months (late 2022 and early 2023). With the additional close, Prilenia has raised $144 million to date and continues to prioritize rapid development of novel therapeutics for patients and families. Prilenia’s lead asset, pridopidine, is a highly selective and potent Sigma-1 receptor (S1R) agonist that is orally administered and has an established safety and tolerability profile. Pridopidine is in late-stage clinical development, being evaluated in the global Phase 3 PROOF-HD trial for Huntington’s disease and in the HEALEY ALS Phase 2/3 platform trial. The company recently completed patient enrollment in PROOF-HD ahead of schedule and above target enrollment numbers. Proceeds from the recent financing will be used to prepare for potential registration and commercialization of pridopidine for HD and ALS, and to accelerate timelines and expand the executive team and operations. The Series B increases Prilenia’s capitalization; the round and prior financings bring total capital invested since the company’s founding in September 2018 to $133.5M. Prilenia is based in Naarden (Netherlands), Herzliya (Israel) and Boston, MA (U.S.), and pridopidine has been granted orphan drug designation for HD in both the U.S. and Europe. Prilenia Therapeutics is a clinical-stage biotechnology company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders. Its lead compound, pridopidine, is a highly selective sigma-1 receptor (S1R) agonist shown to maintain functional capacity in early Huntington’s disease as measured by the Total Functional Capacity score. Pridopidine was also selected for inclusion in the first-ever ALS platform trial led by the Healey Center for ALS at Massachusetts General Hospital. The company plans to use new funding to launch a Phase 3 trial in HD and participate in the ALS platform trial, both expected to commence in H2 2020. Prilenia was founded in September 2018 and operates from Naarden, the Netherlands and Herzliya, Israel. Michael R. Hayden was appointed CEO at the close of the financing; a new Dutch holding company was formed to hold the Israeli subsidiary.