Novel therapeutic blocks nerve cell death and inflammation
Clinical trials slated for 2016
Cambridge, MA, November 17, 2015 – Amylyx Pharmaceuticals today announced it has received $600,000 from the ALS Finding a Cure Foundation and the Cure Alzheimer’s Fund to support IND-enabling studies for the company’s lead candidate, AMX0035. The Company has also raised new private investor funding, bringing the total raised to $1.9 million. AMX0035 has exhibited positive preclinical results in blocking neuroinflammation and nerve cell death and is positioned to enter clinical trials in ALS in 2016.
“The ALS Finding a Cure Foundation is committed to pursuing multiple avenues toward a cure for ALS,” said Merit Cudkowicz, MD, the Foundation’s chief medical officer, Professor of Neurology at Harvard, and Chief of Neurology at Massachusetts General Hospital. “AMX0035 has shown promise in preclinical models. This grant will underwrite studies needed to begin clinical trials.”
ALS and other neurodegenerative diseases such as Alzheimer’s are characterized by nerve cell death and inflammation. Together these processes form a toxic cycle that is a key driver of progressive neurological decline. AMX0035 is an oral, proprietary combination of two known compounds that is designed to break this cycle and prevent the further progression of neurodegenerative disease. AMX0035’s potent therapeutic ability has been confirmed in multiple models of ALS and Alzheimer’s as well as models of cell death and inflammation.
“Across all neurodegenerative diseases from Alzheimer’s to ALS, one of the major sources of neuronal cell death is inflammation and oxidative damage,” said Rudy Tanzi, PhD, Professor of Neurology at Harvard Medical School, Director of the Genetics and Aging Unit at Massachusetts General Hospital, and Chairman of Amylyx’s Scientific Advisory Board. “If we can prevent neuroinflammation, there is an excellent chance that we will significantly ameliorate or postpone onset of clinical symptoms across many common neurological disorders.”
In addition to Professor Tanzi, Amylyx has built a strong team of industry and academic leaders, including Dr. George Milne, former President of Central Research at Pfizer and Radius Venture Partner, and Stephen D. Chubb, previous CEO of three publicly-traded biotechnology companies and currently Special Limited Partner at Catalyst Health Ventures.
“We are honored by the support from ALS Finding a Cure, the Cure Alzheimer’s Fund, and our investors,” said Joshua Cohen, Co-Founder and CEO of Amylyx. “We are excited to work toward a meaningful therapy for patients suffering from this devastating disease and anticipate launching an initial clinical trial in ALS in 2016.”
Amyotrophic lateral sclerosis, ALS, is the most prevalent, adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the US and an estimated 450,000 people worldwide. ALS causes the progressive degeneration of motor neurons, resulting in rapidly progressing muscle weakness and atrophy that eventually leads to partial or total paralysis; on average the disease is fatal within just four years. There is just one medicine approved specifically for treating ALS, riluzole, and it only extends survival by about 10 percent.
About Amylyx Pharmaceuticals
Amylyx is developing a novel therapeutic for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases that targets the neuroinflammation and nerve cell death that characterize these disorders. The company’s therapeutic, AMX0035, is a proprietary combination of existing compounds that Amylyx has shown have synergistic effects in preventing cell death and neurotoxic inflammation in multiple preclinical models. AMX0035 is expected to enter clinical trials in ALS patients in 2016. Learn more at: www.amylyx.com.
Forward Looking Statements
Some statements in this press release are not historical facts and constitute “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 that are based on current expectations of Amylyx management. Forward-looking statements are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. The reader is cautioned not to rely on these forward-looking statements. Amylyx does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release.
Justin Klee Peter Steinerman
President Steinerman Biomedical Communications
Amylyx Pharmaceuticals (516)641-8959