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Caeregen Therapeutics

October 18, 2023
Franciscan D
Ophthalmology
Caeregen is a breakthrough regenerative medicine therapeutics company targeting neurosensory diseases, with a revolutionary first drug, CTR-107 (Noregen), for vision loss and blindness from retinal diseases. Caeregen's first-in-class technology generates synthetic human proteins to selectively activate pathways to repair damaged tissues and restore normal function. In-vitro and in-vivo studies have shown CTR-107 reactivates the pathways used in initial retinal development to repair and regenerate the blood vessels, capillaries and neuronal structures of the retina to protect and restore vision. While CTR-107 has the potential to revolutionize patient care in multi-billion dollar ischemic retinal disease indications such as Retinal Vein Occlusion (RVO), Macular Degeneration (MD), Diabetic Macular Edema (DMA) and Diabetic Retinopathy (DR), Caeregen is first targeting the rare, inherited eye disease of Familial Exudative Vitreoretinopathy (FEVR; no approved treatments), as the fastest, most capital efficient, clinical proof-of-concept and path to market. This approach is guided by Caeregen's world recognized leaders with >100 years' experience in retinal disease research, therapeutics, and clinical care; the largest independent biobank of inherited retinal diseases; and the largest network of retinal disease clinical research practices in N. America. CTR-107 is in IND-enabling pre-clinical development with its first-in-patient Phase I/II FEVR study to start in 1H24 and initial data in 2H24. A Phase II confirmatory FEVR study in enables US FDA filing for in FEVR in 2026-27. The strength of CTR-107's activity data has enabled robust regulatory progress including US FDA acceptance as a potential therapeutic for FEVR; US FDA and EU EMA attainment Orphan Drug Designation in FEVR; US FDA Rare Pediatric Disease Designation, and; US FDA Priority Review Voucher (PRV) eligibility, (>$100 Million market value at approval). Caeregen's other synthetic protein programs target hearing loss and neurodegenerative diseases. The Company's broad and deep validated platform comprises >35 US/International patents on compositions of matter, proprietary proteins and regenerative science. Caeregen is currently raising US $20M in Series A Funding from investors and strategic partners (for co-development / licensing) to complete Noregen IND-enabling studies, manufacture clinical drug supply and complete the Phase I/II FEVR-patient study in 2024.
Speakers
Walter Capone - Caeregen Therapeutics