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 Green Light for World's First New Drug Development

GemVax & KAEL Co., Ltd. (GemVax, 082270) announced on the 13th that the U.S. Food and Drug Administration (FDA) approved their Investigational New Drug (IND) application for a Phase 2 clinical trial of GV1001, aimed at treating progressive supranuclear palsy (PSP), on October 9 (local time).

With this approval, GemVax's global development of GV1001 for PSP is now fully underway. PSP currently has no cure and is classified as one of the Parkinsonian syndromes due to its similarities to Parkinson’s disease. However, PSP progresses more rapidly and responds poorly to existing Parkinson’s treatments, underscoring the urgency for new therapies.

GemVax plans to evaluate the efficacy and safety of GV1001 in this trial, where either 0.56 mg or 1.12 mg of the drug will be administered subcutaneously to 150 PSP patients over 12 months across 30-40 medical institutions. The company also intends to seek approval from regulatory bodies in the UK and the European Medicines Agency (EMA) in the near future.

The company has already initiated clinical trials for PSP in Korea. As of June, 59 patients (79% of the target) have been enrolled, and the trials are progressing smoothly.

Preclinical trials of GV1001 have demonstrated statistically significant improvements in motor and spatial cognitive functions, as well as the inhibition of tau protein damage associated with PSP. GV1001, composed of human telomerase-derived peptides, has also shown anti-aging, antioxidant, and anti-inflammatory effects. Following its successful Phase 2 trials for Alzheimer’s disease, GemVax expects similarly positive results from the ongoing domestic and international PSP trials.

A GemVax representative commented, "GV1001 has been shown to improve the immune environment in the brain and reduce inflammation. Building on our success in Korea, and with international regulatory bodies now confirming its therapeutic potential, we are dedicating all our efforts to establishing GV1001 as the world’s first treatment for PSP."

Additionally, GemVax has applied for orphan drug designation for GV1001 in Korea after receiving a recommendation from the Korea Orphan & Essential Drug Center. If the domestic Phase 2 trial demonstrates efficacy, the company plans to pursue conditional approval for commercialization. They will also seek orphan drug status in other regions, including the U.S. FDA.

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