SKYE - Skye Bioscience receives Australia approval to start phase 1 study of glaucoma treatment
- Skye Bioscience ( OTCQB:SKYE ) said on Thursday it had received Australian regulatory approval to begin its first-in-human Phase 1 study of SBI-100 Ophthalmic Emulsion to treat glaucoma.
- The main goal of the study of SBI-100 are an assessment of safety and tolerability of the drug in healthy volunteers.
- The company said preliminary top-line data is expected in Q4 and final data in Q1 of 2023.
- SKYE said that conducting the Phase 1 clinical study in Australia qualifies it to receive a tax credit of up to 43.5%.
- "We aim to submit an investigational new drug ( IND ) application, which is not dependent upon Phase 1 data, with the FDA by year-end for our planned US-based Phase 2 in 2023 to assess efficacy and safety in patients with glaucoma," the company said.
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Skye Bioscience receives Australia approval to start phase 1 study of glaucoma treatment