· Identified and characterized in vivo a novel, patented by SAJE, lead compound, SPL-850
· Filed wide international patent rights for SPL-850 and related molecules
· Characterized clean safety data for SPL-850
· Understanding novel PK/PD relationships of SPL-850 and active routes of administration: oral, topical, intravitreal, IP, IV
· New understanding that S-nitrosoglutathione (GSNO), a natural, non-toxic, highly bioavailable metabolite essential for life, is the “real” API of GSNORi technology and that SPL-850 and other GSNOR inhibitors facilitate, by preventing its breakdown, the increased abundance of GSNO, the therapeutically active molecule that nitrosylates signal and other critical proteins to regulate them
· Identified 56 therapeutic activities of GSNO and GSNORis, including SPL-850 (see list under the Science Section)
· Added GSNORi SPL-850 efficacy in new animal models:
1. Topical ocular anti-inflammatory activity equal to or superior to prednisolone acetate, a steroid standard of care. Suggests that SPL-850 could become a safe replacement for steroids in ocular and other therapeutic application
2. Strong oral therapeutic activity in an IBD model equal to or better than two standard of care drugs. These data add to the list of autoimmune therapeutic activities of GSNORis and suggest that SPL-850 could become a safe, autoimmune inhibiting alternative to existing drugs including steroids, with more mechanisms of therapeutic action
· Targeted clinical trials in Autoimmune Conjunctivitis and Dry Eye by topical application as the first disease indications with large unmet medical needs, expanding markets, and faster and less expensive clinical development to both Proof of Clinical Concept and a marketable drug, SPL-850.
· Developed a proposed program of label expansion with larger partners for: retinal ocular diseases such as AMD, Glaucoma, diabetic retinopathy; other neurodegenerative diseases as Alzheimer’s, multiple sclerosis, Parkinson’s; cardiovascular diseases such as heart attack, heart failure, & stroke; and other autoimmune diseases such as rheumatoid and osteo-arthritis, inflammatory bowel diseases, scleroderma, etc.