AlphaNavi Pharma

About AlphaNavi Pharma

AlphaNavi Pharma Inc. is a Japanese clinical-stage biotechnology company focused on developing novel, non-opioid analgesics for neuropathic pain. Established in January 2019, the firm was created as a carve-out venture from Sumitomo Dainippon Pharma (now Sumitomo Pharma Co., Ltd.) by two of its employees, Yoshihiro Oyamada and Yoji Hayashi, with support from Kyoto University Innovation Capital (Kyoto iCAP). The President and CEO is Yoshihiro Oyamada, Ph.D.

The company's primary business involves advancing its pipeline of drug candidates through clinical development and then out-licensing the commercialization rights to larger pharmaceutical partners. This strategy allows AlphaNavi to concentrate on the research and development phases for indications with high unmet medical needs, particularly rare pain diseases linked to genetic mutations. The company has secured funding through Series A and B rounds, with investors including Kyoto iCAP, Sumitomo Pharma, SMBC Venture Capital, and Nippon Venture Capital.

AlphaNavi's lead asset is ANP-230, a potent and selective inhibitor of the voltage-gated sodium channels Nav1.7, Nav1.8, and Nav1.9. These channels are predominantly expressed in the peripheral nervous system, and gain-of-function mutations are known to cause treatment-resistant pain syndromes. A key feature of ANP-230 is its inhibition of Nav1.9, a target for which it may be the only clinical-stage compound. Its high selectivity for peripheral nerves and low penetration of the blood-brain barrier minimizes central nervous system (CNS) and cardiovascular side effects. ANP-230 has completed multiple Phase 1 studies in the US, UK, and Japan, demonstrating good tolerability, and is currently in a Phase 1/2 study in Japan for Nav1.9-mutated familial episodic limb pain.

The company's pipeline also includes ANP-390, a selective Nav1.7 inhibitor. In October 2023, AlphaNavi exercised its option rights to acquire the worldwide exclusive license to develop, manufacture, and commercialize this compound, formerly known as DSP-3905, from Sumitomo Pharma. ANP-390 has completed a Phase 1 study in the US. AlphaNavi is actively seeking out-licensing opportunities to expand the clinical development of both ANP-230 and ANP-390 for broader neuropathic pain indications in the US, EU, and China.