Neuromagen Pharma Ltd., developer of a new class of drugs to treat degenerative and senescence-associated diseases, has received FDA Orphan Drug Designation for AGS-499 its lead drug candidate, which has shown significant effectiveness in delaying the onset and progression of ALS (Amyotrophic Lateral Sclerosis).
BEER-SHEVA, Israel, May 5, 2022 -- Neuromagen Pharma Ltd., developer of a new class of drugs to treat degenerative and senescence-associated diseases, has received FDA Orphan Drug Designation for AGS-499 its lead drug candidate, which has shown significant effectiveness in delaying the onset and progression of ALS (Amyotrophic Lateral Sclerosis).
The Orphan Drug Designation program provides orphan status to drugs and biologics which are intended for the treatment, prevention or diagnosis of a rare disease or condition, and affects less than 200,000 people in the U.S. This designation will provide Neuromagen with seven years of marketing exclusivity for AGS-499 following the approval and launch for ALS treatment.
AGS-499 has shown outstanding neurogenesis and neuroprotective effects in neuronal cells from ALS patients and also demonstrated delayed onset and delayed progression of ALS in mouse models in a dose and time-dependent manner.
Neuromagen’s AGS patent-protected family of drugs consists of molecules that activate telomerase reverse transcriptase (TERT). Telomerase is a key enzyme for cell lifespan and survival that prevents telomere shortening and controls cell senescence. The drugs demonstrated preclinical efficacy in ALS and neurodegenerative diseases (Alzheimer’s) as well as Diabetes, fertility, and cardiovascular disease.
“We’re pleased that the FDA designation will provide financial and regulatory benefits as well as exclusive protection to commercialize AGS-499,” says Prof. Esther Priel, Founder and CTO of Neuromagen. Prof. Priel is also head of the Laboratory for Nucleic Acids Topology, at Ben-Gurion University of the Negev. “We believe this treatment approach holds great potential and look forward to beginning clinical trials for AGS-499 while continuing to develop our pipeline.”
“The FDA Orphan Drug Designation is an important milestone for this potential ALS drug development, a disease for which there is no known cure,” says Gil Ben-Menachem, Neuromagen Founder & CEO.” Neuromagen will develop the ALS drug in-house and is pursuing collaborations with pharmaceutical partners in other therapeutic areas.”
About Neuromagen Pharma
Neuromagen Pharma Ltd. is an early-stage pharmaceutical company developing a new class of innovative small molecules which activate telomerase reverse transcriptase (TERT) – an enzyme which plays a major role in aging-related diseases and in cellular senescence. Neuromagen’s pipeline includes drugs for neurodegenerative diseases such as ALS and Alzheimer’s, type 1 diabetes, fertility, and cardiovascular diseases.
For further information, please visit Neuromagen.com.