Phase 1 study to assess safety of FTX-101, a therapeutic agent under development for regeneration of damaged myelin in Chronic Optic Neuropathy
Company expects study to commence in Q4 2024
MONTREAL, Canada I August 27, 2024 I Find Therapeutics Inc., a biopharmaceutical company focused on the development of innovative therapies for autoimmune diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared its Investigational New Drug (“IND”) application for FTX-101, enabling the company to initiate its planned Phase 1 clinical study of FTX-101 in healthy volunteers. The company anticipates the commencement of the study in Q4 2024.
“The FDA’s clearance of our IND marks an important achievement for Find, allowing us to proceed with our Phase 1 study of FTX-101, a potentially novel remyelination therapy under development for the treatment of Chronic Optic Neuropathy, or CON,” said Philippe Douville, CEO of Find. “We look forward to evaluating FTX-101 in Phase 1 clinical studies, bringing us a step closer to finding a solution for people suffering from CON for whom currently no approved therapy exists.”
The Phase 1 clinical trial is expected to be a single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate safety, tolerability, and pharmacokinetics of FTX-101 across different dose levels. The study is expected to enroll up to 80 participants.
About FTX-101
Find’s lead compound, FTX-101, is a first-in-class remyelinating agent that aims to restore vision in people suffering from Chronic Optic Neuropathy (CON). FTX-101 is a rationally designed therapeutic peptide that targets Plexin A1 and Neuropilin 1, a receptor complex present in the brain that has been shown to be involved in the migration and differentiation of oligodendrocyte precursor cells into myelinating oligodendrocytes. Compelling preclinical data for FTX-101 in demyelinating models show strong myelin repair activity.
About Chronic Optic Neuropathy
Chronic Optic Neuropathy is a serious and debilitating demyelinating disease of the optic nerve and visual tracts of the brain. Despite the availability of immunomodulatory drugs on the market that control inflammation and new relapses, there is a major unmet medical need to find safe and effective treatments that can repair damaged myelin in the optic nerve and visual tracts of the brain to preserve axonal function and restore vision in CON. CON affects approximately 90,000 patients in the U.S. alone.
About Find
Find Therapeutics is dedicated to the development of next generation therapies to treat inflammatory autoimmune diseases. The company was launched in 2020 with investments from CTI Life Sciences, adMare BioInnovations and Domain Therapeutics and an exclusive license from Strasbourg University on a technology and related know-how initially developed by Dr. Dominique Bagnard. Visit www.findtherapeutics.com for more details about Find Therapeutics.
SOURCE: Find Therapeutics
Post Views: 4,411
Phase 1 study to assess safety of FTX-101, a therapeutic agent under development for regeneration of damaged myelin in Chronic Optic Neuropathy
Company expects study to commence in Q4 2024
MONTREAL, Canada I August 27, 2024 I Find Therapeutics Inc., a biopharmaceutical company focused on the development of innovative therapies for autoimmune diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared its Investigational New Drug (“IND”) application for FTX-101, enabling the company to initiate its planned Phase 1 clinical study of FTX-101 in healthy volunteers. The company anticipates the commencement of the study in Q4 2024.
“The FDA’s clearance of our IND marks an important achievement for Find, allowing us to proceed with our Phase 1 study of FTX-101, a potentially novel remyelination therapy under development for the treatment of Chronic Optic Neuropathy, or CON,” said Philippe Douville, CEO of Find. “We look forward to evaluating FTX-101 in Phase 1 clinical studies, bringing us a step closer to finding a solution for people suffering from CON for whom currently no approved therapy exists.”
The Phase 1 clinical trial is expected to be a single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate safety, tolerability, and pharmacokinetics of FTX-101 across different dose levels. The study is expected to enroll up to 80 participants.
About FTX-101
Find’s lead compound, FTX-101, is a first-in-class remyelinating agent that aims to restore vision in people suffering from Chronic Optic Neuropathy (CON). FTX-101 is a rationally designed therapeutic peptide that targets Plexin A1 and Neuropilin 1, a receptor complex present in the brain that has been shown to be involved in the migration and differentiation of oligodendrocyte precursor cells into myelinating oligodendrocytes. Compelling preclinical data for FTX-101 in demyelinating models show strong myelin repair activity.
About Chronic Optic Neuropathy
Chronic Optic Neuropathy is a serious and debilitating demyelinating disease of the optic nerve and visual tracts of the brain. Despite the availability of immunomodulatory drugs on the market that control inflammation and new relapses, there is a major unmet medical need to find safe and effective treatments that can repair damaged myelin in the optic nerve and visual tracts of the brain to preserve axonal function and restore vision in CON. CON affects approximately 90,000 patients in the U.S. alone.
About Find
Find Therapeutics is dedicated to the development of next generation therapies to treat inflammatory autoimmune diseases. The company was launched in 2020 with investments from CTI Life Sciences, adMare BioInnovations and Domain Therapeutics and an exclusive license from Strasbourg University on a technology and related know-how initially developed by Dr. Dominique Bagnard. Visit www.findtherapeutics.com for more details about Find Therapeutics.
SOURCE: Find Therapeutics
Post Views: 4,411
