Cambridge, Massachusetts, August 31, 2020 - Anida Pharma, a preclinical stage biopharmaceutical company focused on developing treatments for vision and hearing loss, today announced that the U.S. Food and Drug Administration (FDA) has granted the designation of rare pediatric disease to AP-001, a treatment in development for the prevention of retinopathy of prematurity (ROP). “This is a further significant recognition of our program aimed at preventing vision loss in prematurely born infants, and further recognizes Anida’s efforts to serve pediatric conditions with high unmet medical needs”, said Per Gjorstrup MD PhD, Anida President and CEO. The Rare Pediatric Disease Designation (RPDD) will qualify Anida to receive fast track review upon submission for marketing approval. With approval Anida will be eligible for a priority review voucher (PRV), which as fully transferable may provide a substantial financial benefit.

Cambridge, Massachusetts, March 31, 2020 --- Anida Pharma, a preclinical stage biopharmaceutical company focused on developing treatments for vision and hearing loss, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AP-001 for the prevention of retinopathy of prematurity (ROP). “This is a significant milestone in our development of a safe and efficacious treatment for ROP which can be administered to infants at risk to prevent the development of the condition. No such treatment currently exists and the simple administration of AP-001 as an eye drop from birth through to full gestational age could become a game-changer in treatment of these children”, said Per Gjorstrup MD PhD, Anida President and CEO, “and further encourage our ongoing development towards clinical studies”. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan drug designation provides to Anida certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.

Cambridge, Massachusetts, September 7, 2018 --- Anida Pharma, a preclinical stage biopharmaceutical company, today presented data on its lead candidate AP-001 for the protection of drug-induced hearing loss. Extending on previously presented data at ARO 2018 AP-001 was now shown to have prolonged action and a favorable dissociation between pharmacodynamics and perilymph pharmacokinetics. “The information of prolonged protection, and achieving that even without specific formulation needs, points to a significant clinical advantage as does the rapid distribution of AP-001 to the perilymph following transtympanic administration” said Per Gjorstrup MD PhD, Anida President and CEO.

Cambridge, Massachusetts, June 7, 2018 --- Anida Pharma, a preclinical stage biopharmaceutical company, today presented data on its lead candidate AP-001 on amelioration of neonatal brain ischemia and stroke. In collaboration with the laboratories of Drs. Donna Ferriero and Fernando Gonzales at UCSF and Dr. Henrik Hagberg at Gothenburg University, the presented data showed that AP-001 administered systemically post-insult prominently reduced infarct size and tissue loss in a model of neonatal stroke and in the Vannucci model of neonatal brain ischemia, respectively. “We are very pleased with the outcomes of both studies and the investigators assessment that the program merits further development towards clinical investigation” said Per Gjorstrup, MD PhD, Anida President and CEO. About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is a pleiotropic endogenous lipid-derived small molecule, which in a broad range of experimental studies is shown to dampen inflammation, while preventing death of affected host tissue cells, including oxidative stress, and stimulating tissue repair, including neurogenesis.

Cambridge, Massachusetts, June 5, 2018 --- Anida Pharma, a preclinical stage biopharmaceutical company, today announced that the United States Patent and Trade Mark Office has issued a second patent to Anida for the protection from and treatment of hearing loss and related conditions. “Our second patent, US 9,987,244, in the field adds significant strength to the further development of AP-001 for a broad range of conditions related to hearing loss” said Per Gjorstrup MD PhD, Anida President and CEO. About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is a pleiotropic endogenous lipid-derived small molecule, which in a broad range of experimental studies is shown to dampen inflammation, while preventing death of affected host tissue cells, including oxidative stress, and stimulating tissue repair, including neurogenesis.

Cambridge, Massachusetts, April 13, 2018 --- Anida Pharma, a preclinical stage biopharmaceutical company, today announced it has successfully completed a pre-IND (Investigational New drug) review with the U.S. Food and Drug Administration (FDA). “We are highly encouraged by the confirmation we received from the FDA on our proposal for IND-enabling preclinical studies and first-in-man clinical studies to bring AP-001 forward as a prophylactic treatment for the prevention of drug-induced hearing loss”, said Per Gjorstrup MD PhD, Anida President and CEO. In particular children treated for blastomas have a high risk of hearing loss due to the toxic side-effects of cisplatin, but also carboplatin, as a common base in curative treatments. AP-001 is intended to be delivered locally to the ears to avoid any interference with the chemotherapy. No such treatment is approved today. About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is a pleiotropic endogenous lipid-derived small molecule, which in a broad range of experimental studies is shown to dampen inflammation, while preventing death of affected host tissue cells, including oxidative stress, and stimulating tissue repair, including neurogenesis, collectively contributing to prevention of hearing loss.

Cambridge, Massachusetts, February 13, 2018 --- Anida Pharma, a preclinical stage biopharmaceutical company, today presented data on its lead candidate AP-001 for the protection of drug-induced hearing loss. Building on excellent in vitro data showing regulation of reactive oxygen species formation by controlling key enzymes in addition to downregulating stressed-induced inflammation, AP-001 was shown to dose- dependently protect from cisplatin-induced hearing loss in a commonly accepted translational model. Administered to the middle ear as prophylactic treatment, as intended in the clinic, AP-001 at the top dose gave full protection. “We are extremely satisfied with the in vivo data now obtained and confirmation of the relevance of the mechanistic data for otoprotection that we obtained in cellular experiments” said Per Gjorstrup MD PhD, Anida President and CEO. “We also want to acknowledge the excellent collaboration with the hearing loss research group at Southern Illinois University”. About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is a pleiotropic endogenous lipid-derived small molecule, which in a broad range of experimental studies is shown to dampen inflammation, while preventing death of affected host tissue cells, and also stimulating tissue repair, including neurogenesis.

Cambridge, Massachusetts, June 19, 2017 --- Anida Pharma, a preclinical stage biopharmaceutical company, today announced it has successfully completed a pre-IND (Investigational New drug) review with the U.S. Food and Drug Administration (FDA). “We much appreciate the positive feedback we received from the FDA on our proposal for IND-enabling preclinical studies and first-in-man clinical studies for ophthalmic indications with AP-001 with a focus on retinal disease, including age-related macular degeneration (AMD) and retinopathy of prematurity (ROP)”, said Per Gjorstrup MD PhD, Anida President and CEO. “In particular, this may become a first treatment indicated for the prevention of ROP to be delivered as a non-invasive eye drop”. About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is a pleiotropic endogenous lipid-derived small molecule, which in a broad range of experimental studies is shown to prevent ocular neovascularization, through control of inflammation and oxidative stress, while directly regulating cell death pathways and stimulating tissue repair.

Cambridge, Massachusetts, October 18, 2016 --- Anida Pharma, a preclinical stage biopharmaceutical company, today announced that the United States Patent and Trade Mark Office has issued a patent to Anida broadly covering protection from and treatment of hearing loss and related conditions. “As leaders in the field of developing treatments for hearing loss the now issued patent, US 9,468,620, offers additional protection beyond the already issued composition of matter patent licensed to Anida” said Per Gjorstrup MD PhD, Anida President and CEO. “The patent adds to Anida’s strong position in other indications of particular development interest for us, US patent 9,340,483 for the treatment of ALS, as well as US patent 9,315,447 broadly covering ophthalmic indications, giving us a strong position moving forward”. About AP-001: also known as neuroprotectin D1 (NPD1; protectin D1; PD1), AP-001 is a pleiotropic endogenous lipid-derived small molecule, which in a broad range of experimental studies is shown to dampen inflammation, while preventing death of affected host tissue cells, including oxidative stress, and stimulating tissue repair, including neurogenesis.