Release Date: 08-Sep-2021
Spinogenix, Inc. a pharmaceutical company has been granted Orphan Drug Designation for SPG302 in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) by the U.S FDA. SPG302 is an orally bioavailable, blood-brain barrier penetrating small molecule. Its mode of action regenerates lost synapses and has shown developments in motor and cognitive behaviors in multiple animal models of neurodegenerative disorders.
Moreover, Spinogenix Company reports the positive completion of pre-IND (Investigational New Drug) interaction with the FDA regarding the current development plan for SPG302. The FDA agreed to the overall development program including the first-in-human Phase 1/2 clinical study in ALS patients followed by a Phase 2/3 Pivotal trial based on safety/PK/biomarker data.
The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.A