Development of New Formulations for Alzheimer's Disease Based on Mirodenafil
SK Chemicals is strengthening its collaboration with its technology transfer partner, AriBio, regarding mirodenafil, which was developed by SK Chemicals.
On October 22, SK Chemicals announced that it had signed a memorandum of understanding (MOU) with AriBio to explore opportunities for expanding the development of AR1001-an oral treatment for Alzheimer's disease whose active ingredient is mirodenafil-and for global market entry.
AR1001 is based on mirodenafil, which was developed by SK Chemicals. AriBio has been developing this compound as a treatment for dementia since it obtained the technology transfer from SK Chemicals in 2011. Currently, the efficacy and safety of the treatment are being verified through global Phase 3 clinical trials in 13 countries.
Through this agreement, the two companies plan to continue discussions on various areas of collaboration, including the development of next-generation formulations of mirodenafil, global clinical trial cooperation, and manufacturing and export after the commercialization of AR1001. This MOU was signed based on a shared understanding between the two companies regarding the progress of AR1001’s global Phase 3 clinical trials and its commercialization potential. The specific details of future collaboration will be determined through further discussions.
Jung Jaejoon, CEO of AriBio, stated, "With the commercialization of an oral Alzheimer's disease drug developed in Korea now within reach, we will do our utmost to combine our strengths and achieve results in the global market through this collaboration."
Park Hyunsun, Head of the Pharma Business at SK Chemicals, said, "We will actively collaborate with AriBio so that mirodenafil, which we developed, can expand to treat various diseases such as dementia and become a leading example of drug repurposing."
Meanwhile, the global Phase 3 clinical trial (POLARIS-AD) for AR1001 being conducted by AriBio has completed enrollment of 1,535 patients across 13 countries, including the United States, seven European countries, Korea, and China, and has entered its final stage. AriBio plans to complete the clinical trial in the first half of 2026 and release the primary results first, followed by submitting a New Drug Application (NDA) to the U.S. FDA by the end of the same year. AR1001 is being developed as a multi-mechanism drug that acts on various pathological pathways, including protecting and promoting the generation of nerve cells, inhibiting the accumulation of toxic proteins, and improving cerebral blood flow, with the aim of slowing the progression of cognitive decline.
GlobalData, a UK-based market research firm, has evaluated AR1001 as one of the most promising new drug candidates for Alzheimer's disease, citing its differentiated mechanisms of action, safety, and convenience of administration as key factors for its future sales potential and marketability.
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