As Shinshin Pharmaceutical, a transdermal drug delivery platform company, accelerates the development of its improved new drug pipeline, its portfolio is expected to diversify. Following 'UIP-620,' which has entered domestic Phase 3 clinical trial preparations, Shinshin Pharmaceutical will initiate Phase 1 clinical trials within the year to develop the insomnia treatment 'SS-262.'
On the 1st, Shinshin Pharmaceutical announced that it will complete the government-funded project "Development of a Sleep-Inducing Patch Containing Melatonin" by August and proceed with the IND (Investigational New Drug) application for Phase 1 clinical trials. The company aims to obtain approval for SS-262 within this year and complete Phase 1 clinical trials by 2024.
In 2021, Shinshin Pharmaceutical was selected for the bio-medical technology commercialization government project by the Seoul Business Agency and has been developing SS-262 for insomnia. The project’s main goal is to complete preclinical trials of SS-262 and submit the Phase 1 clinical trial application by the 31st.
Through the government project, Shinshin Pharmaceutical has nearly completed the preclinical procedures for SS-262 development and is currently designing the Phase 1 clinical trial protocol. Upon approval of Phase 1, the drug’s safety will be evaluated in a small group of healthy adults.
Based on its research and development capabilities in the transdermal drug delivery system (TDDS) field, Shinshin Pharmaceutical has reduced the drug delay time and increased absorption for SS-262. The company explained that its TDDS technology can resolve issues related to drug crystallization and stability found in existing melatonin-based treatments.
Shinshin Pharmaceutical already holds two patents registered in 2017 and 2020 related to the development of SS-262. The patented technologies are for "transdermal absorption formulations containing melatonin" and "transdermal absorption formulations for treating sleep disorders," focusing on methods to maximize drug delivery effects.
A Shinshin Pharmaceutical representative stated, "If SS-262 is commercialized, it will become the world's first patch-type insomnia treatment as a prescription drug," adding, "New drugs based on the transdermal drug delivery platform are expected to create synergy effects in the research and development of other pipelines through the technologies secured during the development process."
They continued, "Shinshin Pharmaceutical is already exporting melatonin-based patch products to the North American market, and additional exports will be possible with the development of SS-262," noting, "The U.S. insomnia treatment market has already attracted attention, surpassing 1 trillion KRW in 2019."
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