Naarden, The Netherlands, 17 November 2021 – Forbion, a leading European life sciences venture capital firm, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pridopidine for development as a potential treatment for Huntington’s Disease (HD). Pridopidine is being developed by Prilenia Therapeutics BV (Prilenia), a Forbion portfolio company.
Fast Track designation may accelerate the registration process for Pridopidine by providing the ability to file a rolling new drug application (NDA) and qualify for priority review.
Pridopidine acts as a highly selective and potent Sigma-1 Receptor (S1R) agonist and is currently being assessed in PROOF-HD (PRidopidine Outcome On Function in Huntington Disease), a global phase 3 clinical trial. Prilenia recently announced the completion of enrolment in the PROOF-HD clinical trial ahead of schedule.
Geert-Jan Mulder MD, Chairman of Prilenia and Managing Partner at Forbion commented: “This news emphasizes the potential future impact of the Pridopidine programme and the hope for patients with Huntington’s Disease and their families, while also marking another major milestone for the Company. The team at Prilenia again demonstrates outstanding execution of the ongoing development program of this promising therapeutic with the potential to help those living with Huntington’s Disease, a large population of individuals with high unmet need.”
Dr. Michael R. Hayden, CEO and Founder of Prilenia commented: “Receipt of Fast Track designation from the FDA underscores the urgency to address a significant unmet need for patients with Huntington’s Disease. HD is one of the most devastating neurodegenerative disorders, impacting not only patients but their families. At the present time, there is no approved treatment to delay onset or slow the disease's progression. We look forward to working closely with the FDA to making pridopidine a potential option for these patients.”
Pridopidine is orally administered with therapeutic potential in HD, ALS and other neurodegenerative diseases and neurodevelopmental disorders such as Rett and Fragile-X syndromes.
ENDS
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Laura Asbjornsen, Head of Communications
Email: laura.asbjornsen@forbion.com
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Ashley Tapp, Sue Charles
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About Forbion
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 1.7 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of 20 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in over 70 companies. The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, “ERP – Venture Capital Fonds investments”. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.
About Prilenia
Prilenia is a clinical stage biotech start-up founded in 2018 with the purpose of improving the lives of patients and their families by developing treatments for neurodegenerative and neurodevelopmental disorders. Prilenia is backed by a group of well-respected investors including: Forbion, Morningside, Sands Capital, Sectoral Asset Management, Talisman, Amplitude Ventures and the ALS Investment Fund. The Company is based in Naarden, the Netherlands, Herzliya, Israel and Boston, MA in the U.S. For more information visit www.prilenia.com and follow us on Twitter @prileniaTx.