NEWPORT BEACH, CA – GABA Therapeutics, Inc has successfully completed the single ascending dose (SAD) stage of its Phase 1 study of GRX-917 in Melbourne, Australia.
Interim data from the SAD stage showed that GRX-917 was well tolerated and favorable safety results were observed up to 500mg. Furthermore, the results suggest that food substantially increased exposure, which could potentially improve efficacy.
The multiple ascending dose (MAD) study was initiated on September 22nd – and Phase 1 is expected to complete by end of Q1, 2022.
GABA Therapeutics plans to initiate phase 2a proof-of-concept (POC) efficacy studies by end of Q2 2022. Indications currently being evaluated include:
· Social Anxiety Disorder
· Depression, and
· Essential Tremor.
Anxiety and depression are often comorbid. If GRX-917 is successfully developed and approved for both anxiety and depression, it would be attractive to physicians and psychiatrists seeking to address this co-morbidity – particularly if GRX-917 is confirmed to have rapid onset, minimal side effects and be non-addictive.
The combined global market for treatments of anxiety disorder and depression is forecast to exceed USD$19 billion by 2028.
See also atai Life Sciences public filings with the Securities and Exchange Commission, including its earnings release for the quarter ended June 30, 2021, which are available on its investor relations website at ir.atai.life.
For questions contact:
Richard G. Farrell
Chief Financial Officer
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