Israeli Neuromagen Pharma Ltd., a developer of drugs to treat degenerative and senescence-associated diseases, has received FDA Orphan Drug Designation for its lead drug candidate, AGS-499, which has demonstrated significant efficacy in delaying the onset and progression of amyotrophic lateral sclerosis (ALS) (Amyotrophic Lateral Sclerosis).
The Orphan Drug Designation program grants orphan designation to medicines and biologics intended to treat, prevent, or diagnose a disease or condition that affects fewer than two hundred thousand persons in the United States. This designation grants Neuromagen seven years of marketing exclusivity for AGS-499 following ALS therapy approval and launch.
AGS-499 has remarkable neurogenesis and neuroprotective properties in neuronal cells from ALS patients and dose- and time-dependent delayed start and development of ALS in mice models.
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The AGS series of Neuromagen’s patent-protected medications contain compounds that activate telomerase reverse transcriptase (TERT).
Telomerase is a crucial enzyme for cell survival and longevity since it inhibits telomere shortening and regulates cell senescence. The medications shown preclinical effectiveness for ALS, neurological illnesses (Alzheimer’s), Diabetes, fertility, and cardiovascular problems.
Neuromagen was founded in 2021 by Prof. Esther Priel, the director of Ben-Gurion University of the Negev’s Laboratory for Nucleic Acids Topology.
Prof. Priel is thrilled that the FDA designation will give financial and regulatory benefits as well as unique protection for the commercialization of AGS-499. We feel this therapy strategy has enormous potential and look forward to initiating clinical studies for AGS-499 as we continue to build our pipeline.
“The FDA Orphan Treatment Designation is a critical milestone for this possible ALS drug development,” says Gil Ben-Menachem, Neuromagen’s founder and chief executive officer.
Neuromagen will develop the ALS medicine internally and is exploring partnerships with pharmaceutical companies in other therapeutic areas.
