Funding to support advancement of clinical development and potential launch planning of AMX0035 in ALS and further research and development in additional neurodegenerative diseases
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. today announced the closing of an oversubscribed $135 million Series C financing, led by Viking Global Investors, to support the clinical development and potential launch plans for lead product candidate AMX0035, for the potential treatment of ALS, and further research and development in other neurodegenerative diseases.
The financing was led by Viking Global Investors with participation from Bain Capital Life Sciences, Perceptive Advisors, Rock Springs Capital, Woodline Partners, Marshall Wace, Tybourne Capital Management, Verition Fund Management, aMoon Fund and Falcon Edge. Existing investors, including Morningside Ventures, 683 Capital Management, Belinda Termeer and Polaris Founders Capital, also participated in the financing.
“We have a clear mission at Amylyx: to develop new medications for ALS and other progressive neurodegenerative diseases. We are eager to work with Viking and our syndicate of experienced biotechnology investors as we execute our plan to hopefully bring AMX0035 to people living with ALS as soon as possible,” said James Frates, chief financial officer of Amylyx Pharmaceuticals, Inc.
As previously reported, Amylyx filed a New Drug Submission (NDS) for AMX0035 for the treatment of ALS with Health Canada in June. Amylyx intends to submit a Marketing Authorization Application (MAA) for AMX0035 to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) by the end of 2021. Amylyx will continue to update the global ALS community on global regulatory plans including with the US FDA and plans to initiate a Phase 3 clinical trial. Data on AMX0035 in people with ALS has been published in the New England Journal of Medicine (NEJM) and Muscle and Nerve.
AMX0035 is an investigational product comprised of two complementary active agents, sodium phenylbutyrate (PB) and taurursodiol (TURSO; also known as ursodoxicoltaurine), which were combined in a co-formulation to reduce neuronal death and dysfunction. AMX0035 was specifically co-formulated and manufactured by Amylyx to ensure proper absorption, exposure, and quality. AMX0035 targets endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases.
About Amylyx Pharmaceuticals
Amylyx Pharmaceuticals, Inc. is a pharmaceutical company working on developing a novel therapeutic for Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases. For more information, visit www.amylyx.com and follow us on LinkedIn and Twitter.