Source: Skye Bioscience, Inc. 3/3/2022
Skye Bioscience, Inc. (OTCQB: SKYE) (“SKYE” or the “Company”), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet need, 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.
About SBI-100
SBI-100,
a proprietary prodrug of tetrahydrocannabinol (“THC”), is a topical
formulation under development to treat glaucoma. Through the application
of rational drug design, SKYE chemically modified THC to create a
unique synthetic molecule with the intent to safely realize the known
positive effects of THC. SBI-100 enables enhanced local delivery of the
drug into the eye, reduced systemic side effects and the potential for
neuroprotection. In preclinical studies, SBI-100 demonstrated superior
lowering of intraocular pressure, a key cause of vision loss, compared
to the top commercially marketed classes of drugs, representing a
potentially transformative treatment option for glaucoma patients
worldwide.
About Skye Bioscience
Skye
Bioscience Inc. is a biopharmaceutical company unlocking the
pharmaceutical potential of cannabinoids through the development of its
proprietary, cannabinoid-derived molecules to treat diseases with
significant unmet needs. The company’s lead program, SBI-100, is focused
on treating glaucoma, a disease with no cure and the world’s leading
cause of irreversible blindness. In preclinical studies, SBI-100
demonstrated intraocular pressure lowering capabilities in patients with
glaucoma or elevated intraocular pressure that is superior to the
current standard of care. For more information, please visit: www.skyebioscience.com.
No comments:
Post a Comment