Skye Bioscience has entered into an agreement with Novotech Health Holdings (“Novotech”), a leading full-service contract research organization (“CRO”) in Asia-Pacific, for its upcoming Phase 1 study in Australia of its SBI-100 drug candidate for the treatment of glaucoma.
Novotech is an internationally recognized full-service biotech specialist CRO known for its experience across the Asia-Pacific region. Novotech will work alongside investigators of the planned study to support aspects of the clinical trial including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, reporting, and project and vendor management.
"We are pleased to bring on one of Asia-Pacific's premier biotech specialist CROs to support our first-inhuman clinical study," stated Punit Dhillon, CEO of Skye Bioscience. "With Novotech's extensive experience in conducting clinical trials, we are optimally positioned to execute this Phase 1 program of SBI-100 in Australia where we expect to conduct this important phase of our development quickly and cost-effectively."
SKYE is actively pursuing a product and clinical development plan with the intent to unlock the full potential of cannabinoids for glaucoma and diseases with significant unmet needs. The company expects to initiate its first-in-human Phase 1 study in Q2-22 with data to be reported in the second half of 2022. Additionally, the Company intends to initiate its proof-of-concept Phase 2 study before the end of the year and will continue to announce its initiatives as they unfold.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox!
Sign up now!