AriBio has secured patents for its oral Alzheimer’s treatment candidate AR1001 (active ingredient: mirodenafil) in the U.S. and Japan, and is now poised to register a patent in Europe.
The company announced on Tuesday that it recently completed the patent registration in Japan and received notification of impending patent registration from the European Patent Office (EPO).
This patent covers the mechanism of action of AR1001 in treating Alzheimer’s disease and is part of the same patent family as the one secured in the U.S. last year (US 12,485,124). Once the European registration is finalized, the scope of intellectual property protection in major pharmaceutical markets is expected to broaden.
The patent, jointly filed by AriBio and SK Chemicals, details a method and composition for reducing amyloid beta formation. It involves using phosphodiesterase-5 (PDE-5) inhibitors, including mirodenafil, to inhibit the aggregation of amyloid beta (Aβ), a key pathological feature of Alzheimer’s disease.
The core innovation lies in preventing amyloid beta from clumping into oligomers and fibers. The patent is projected to remain in force until 2040, provided all registration and maintenance requirements are met.
With this patent acquisition, AriBio is bolstering its product lifecycle management (LCM) strategy for AR1001. The company aims to build an additional patent portfolio to prepare for commercialization and secure long-term market competitiveness.
In May, AriBio inked an option and licensing agreement worth up to 4.7 billion USD with China’s Fosun Pharma for the global development, approval, manufacturing, and commercialization rights of AR1001.
AriBio received the full option payment of 60 million USD in July, as stipulated in the contract. If Fosun Pharma exercises the option after reviewing the Phase 3 clinical trial results, AriBio stands to receive an additional 80 million USD.
Furthermore, on October 22, AriBio completed the payment of 114.75 billion KRW (about 85.6 million USD) as part of a 425 billion KRW (about 317 million USD) third-party allocation capital increase, aimed at securing funds for global commercialization.
AR1001 is an oral treatment candidate designed to address various pathological aspects of Alzheimer’s disease through PDE-5 inhibition.
The global Phase 3 clinical trial POLARIS-AD, conducted on early-stage Alzheimer’s patients, has concluded. The company plans to present the key top-line data at the Alzheimer’s Clinical Trials Conference (CTAD) in Boston on November 16.
This extensive clinical trial involved 1,535 patients across approximately 230 institutions in 13 countries, with 1,348 completing the 52-week treatment regimen. Based on these clinical results, AriBio intends to initiate discussions with the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA).
Meanwhile, the AriBio Group is establishing a comprehensive business framework that spans the prevention, treatment, and management of degenerative brain diseases, including Alzheimer’s. Within this structure, AriBio Lab focuses on prevention, AriBio on treatment, and the holding company AriBio Holdings on management.
