E!10687, Eurostars, GASH02, GT-002 for the treatment of schizophrenia.

Purpose and goal

GT-002 is a new drug candidate with unique properties and potential for various CNS indications. The aim of the project was to further develop GT-002 into a clinical product. A single dose study with increasing doses in healthy volunteers was conducted at CRST in Finland. The study shows that GT-002 is well tolerated and that the new capsule formulation has good pharmacokinetic properties in humans. After a well-conducted clinical phase 1 study, GT-002 is now ready for continued development towards clinical proof-of-concept in patients.

Expected results and effects

A new capsule formulation has been developed that shows very good pharmacokinetic properties in humans. Large-scale GMP production of the clinical product has been established. A SAD study was conducted as a randomized, double-blind, placebo-controlled trial in healthy voluntary male subjects to investigate the safety, tolerability and pharmacokinetic. The results show that GT-002 is safe and well tolerated at doses up to 2 mg, the formulation shows linear dose proportionality in terms of plasma exposure. The results justify continued clinical development of GT-002 in patients.

Planned approach and implementation

The drug GT-002 was advanced from preclinical to clinical phase. It was shown that an oral doses of up to 2 mg were safe, well tolerated by healthy male volunteer subjects. Thus, further clinical development of this novel candidate drug in patients is warranted. The contribution from Vinnova has been of huge importance for the development work of GT-002 towards a clinical product, for ex. enabled further development of the formulation and extended toxicology studies. We look forward with great confidence to the next development phase, where efficacy in patients will be investigated.