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Skye Bioscience (SKYE) investor relations material
Skye Bioscience Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Mechanism and differentiation of CB1 antibody
CB1 pathway regulates energy and fat storage; prior small molecule approaches caused CNS side effects due to brain penetration.
The new antibody is peripherally restricted, avoiding neuropsychiatric adverse events seen with earlier drugs.
Two clinical trials showed no blood-brain barrier crossing and zero neuropsychiatric adverse events.
Preclinical and clinical data insights
Preclinical studies demonstrated weight loss via metabolic rewiring, not just appetite suppression.
Four key effects: appetite hormone regulation, lipid metabolism, improved inflammatory markers, and glycemic control.
Dose response observed; higher doses led to greater weight loss and less rebound compared to small molecules.
Combination with incretins (semaglutide, tirzepatide) showed synergistic weight loss and reduced weight regain.
Preclinical rebound weight regain was 7% vs. 40% for tirzepatide; clinical data mirrors this trend.
Phase II and extension study findings
Phase II monotherapy dose was suboptimal but confirmed safety and some efficacy.
Combination with semaglutide led to 13.5% weight loss at 26 weeks, a 30% improvement over semaglutide alone.
Combination group maintained weight loss better post-therapy, with less regain than semaglutide alone.
Safety profile allows for higher dosing; no additional GI or neuropsychiatric adverse events observed.
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