AP-001 for the Prevention of Hearing Loss
Royal National Institute for Deaf People
Anida Pharma
Anida Pharma is developing AP-001, in the scientific literature referred to neuroprotectin D1 (NPD1), for the prevention of drug-induced hearing loss with the further potential expansion into hearing regeneration. AP-001/NPD1 is an endogenous lipid-derived pleiotropic G protein-coupled receptor agonist with high potency that can best be described as a homeostatic regulator which is upregulated during stresses to control excessive inflammation, accelerate inflammation-resolution while controlling apoptotic events in affected host tissue cells, as well as stimulating tissue repair, and repeatedly confirmed in various CNS and ocular models.   AP-001 was then investigated in the cisplatin-induced ototoxicity model in the rat and shown, when injected transtympanically, to dose-dependently and completely prevent ABR threshold shifts. Pharmacokinetic observations from perilymph sampling further corroborated the effect data. A novel finding in this context was the inhibition of NOX3 and iNOS resulting in no ROS formation, and of high relevance for the prevention of ototoxicity.   AP-001 has the confirmed prerequisite physiochemical characteristics to become a drug candidate and has entered drug product development to identify a suitable formulation for transtympanic delivery for prolonged action to meet clinical needs: rapid onset action yet release drug for sufficient duration to meet practical clinical needs.
5.1 Pharmaceuticals