Jinwon Life Sciences Receives US FDA Approval for Phase 2 Clinical Trial of Chronic Sinusitis Treatment

[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 13th that it has received approval from the U.S. FDA to commence Phase 2 clinical trials for GLS-1200, a natural ingredient-based treatment for chronic sinusitis.

GeneOne Life Science developed the treatment using natural bitter taste receptor signaling substances and related technologies, and is researching the development of various therapeutics utilizing this technology, including the chronic sinusitis treatment GLS-1200.

The clinical trial will be conducted at the Clinical Research Center of the University of Pennsylvania in the United States. It will involve 99 patients who have undergone sinus surgery for chronic sinusitis. Over a period of 7 weeks, GLS-1200 will be administered via nasal spray, followed by a 4-month observation period to assess the recurrence of acute sinusitis, with a placebo-controlled group included.

Park Younggeun, CEO of GeneOne Life Science, stated, "GLS-1200 is a nasal spray treatment using natural substances whose safety has already been confirmed. It allows for easy drug administration and can be developed as a personalized treatment, so a high treatment success rate is expected. We have great expectations as we challenge the large sinusitis treatment market through this Phase 2 clinical trial approval by the U.S. FDA."

According to a GeneOne Life Science official, the Phase 2 clinical trial will begin recruiting and dosing participants once the COVID-19 situation in the U.S. improves.

Sinusitis affects 15-25% of the global population. In South Korea, in 2018, it is reported that 10,543 men and 9,440 women per 100,000 population covered by health insurance received treatment. Generally, antibiotics and symptom-relief treatments are used, but due to the lack of fundamental cures, recurrence tends to occur quickly.

According to a market research report, the global allergic rhinitis treatment market for chronic sinusitis is expected to grow from $11.9 billion in 2016 to $13.9 billion in 2021, with an anticipated annual growth rate of 3.3%.

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