Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication (ACI) and substance abuse disorder (the “Company” or “Anebulo”), today announced the dosing of more than half of the 60 subjects planned in Part A of an ongoing Phase 2 clinical trial at the Centre for Human Drug Research (CHDR) in the Netherlands. The Company believes this progress creates an opportunity to strengthen its development pathway by including Part A data in an upcoming IND submission to the FDA.
“We are pleased to announce the successful dosing of more than half of the subjects in Part A of our ongoing Phase 2 clinical trial, a study designed to evaluate the safety and effectiveness of ANEB-001 in treating ACI,” said Simon Allen, Chief Executive Officer of Anebulo. “Not only does this robust enrollment keep us on track to release top line data for Part A by the end of the first half of calendar 2022, it also enables us to include compelling proof-of-concept data in our IND submission and provides a smoother bridge to initiate ANEB-001 trials in the United States. We now expect to file an IND before the end of this calendar year.”
About Anebulo Pharmaceuticals, Inc.
Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse disorder. Its lead product candidate, ANEB-001, is currently in a Phase 2 clinical trial (www.clinicaltrials.gov/ct2/show/NCT05282797) to evaluate its utility in reversing the negative effects of acute cannabinoid intoxication within one hour of administration. This trial is being run in the Netherlands by the Centre for Human Drug Research (CHDR). ANEB-001 is a competitive antagonist at the human cannabinoid receptor type 1 (CB1). For further information about Anebulo, please visit www.anebulo.com.
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