Anebulo Pharmaceuticals Announces Initiation of Phase 2 Clinical Study Evaluating ANEB-001 for the Treatment of Acute Cannabinoid Intoxication

CANNANNEW REPORT

Affirms expectations for initial topline results in 1H 2022 Recent FDA pre-IND meeting provides valuable guidance on U.S. regulatory path; company expects to submit IND in 1Q 2022 AUSTIN, Texas–(BUSINESS WIRE)–Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, announces that the first patient has been dosed in a Phase 2 proof-of-concept clinical study investigating ANEB-001 as a potential treatment for acute cannabinoid intoxication. In addition, Anebulo recently held a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) during which the company received valuable guidance regarding the clinical development of ANEB-001 in the U.S. Importantly, the FDA noted that a challenge model whereby subjects are exposed to THC in a controlled clinical setting may be acceptable to investigate primary efficacy, which would allow for the more efficient development of ANEB-001. Further, the FDA suggested that Anebulo submit a model-informed drug development (MIDD) paired-meeting request. “The initiation of our Phase 2 study in the Netherlands represents a significant milestone for Anebulo. We continue to anticipate reporting initial topline results from Part A of this trial in the first half of 2022, as we closely monitor the impact of COVID-19. Despite the recently announced national lockdown in the Netherlands, our CRO is continuing to screen and enroll patients,” stated Daniel Schneeberger, M.D., Chief Executive Officer of Anebulo. “Additionally, we are pleased with the guidance provided by the FDA regarding ANEB-001’s clinical and regulatory path in the U.S. We were able to rapidly incorporate the FDA’s feedback into the design of the current Phase 2 trial to make the data generated in Europe as relevant as possible for a potential future NDA submission. We expect to file an IND with the FDA during the first…

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Source : Anebulo Pharmaceuticals Announces Initiation of Phase 2 Clinical Study Evaluating ANEB-001 for the Treatment of Acute Cannabinoid Intoxication

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