Cambridge, Massachusetts, June, 04, 2024 — Anida Pharma, a biopharmaceutical company developing first-in-class treatments for vision loss, today announced the successful completion of a Type B pre-IND meeting with the US Food and Drug Administration (F.D.A.). Anida has previously been granted orphan drug status for AP-001 for the treatment of retinopathy of prematurity (ROP) and was now seeking concurrence on plans for non-clinical IND-enabling studies and guidance on proposed first-in-human study. “Concurrence by FDA on our proposed program sets a clear and efficient path for the development of our program through early clinical studies”, said Per Gjorstrup MD PhD, Anida Founder and CEO.
About ROP: Infants born before gestational week 27 are at risk of vision loss. The earlier born the higher is the risk and more severe is the condition. Inflammation as trigger of pathological blood vessel formation, oxidative stress, and neurodegeneration are main causes of the vision loss. ROP is globally increasing. In the US, with a 50% increase over the last 10 years ,12,000-15,000 infants now develop some degree of ROP and up to 2,000 a severe progressive condition. Long-term complications in addition to vision loss include myopia, strabismus, cataract, and glaucoma.
AP-001 acts as a pleiotropic agonist to modify several pathways involved in the progression of ROP: acting upstream to broadly prevent release of proinflammatory mediators that drive neovascularization and is also retina neuroprotective inhibiting cell death pathways and activating cell survival pathways.