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FDA Gives Green Light for Phase 3 Advancement of ANEB-001 in Positive Feedback Anebulo Wraps Up Phase 2 Extension Dosing

Tuesday, August 22, 2023

Anebulo Pharmaceuticals, Inc. has received positive feedback from the United States Food and Drug Administration (FDA) following a Type B meeting held in July. The FDA's response indicates that the company's plans for a single well-controlled study of ANEB-001 in acute cannabinoid intoxication (ACI) patients, coupled with a larger THC challenge study involving volunteers, could potentially offer significant evidence to back a new drug application. Anebulo is focused on developing innovative solutions for individuals grappling with ACI and substance abuse.

Anebulo Pharmaceuticals, Inc. has received positive feedback from the FDA regarding the development of ANEB-001. This feedback came after a Type B meeting held in July, during which the FDA suggested that conducting a well-controlled study of ANEB-001 in acute cannabinoid intoxication (ACI) patients, along with a larger THC challenge study involving volunteers, could potentially provide strong evidence for a new drug application.

Simon Allen, the CEO of Anebulo, expressed satisfaction with the FDA's response, stating that it paves the way for designing and executing Phase 3 trials for ANEB-001. He emphasized their commitment to finalizing study designs based on this feedback and their ongoing dialogue with the FDA. The goal is to efficiently develop ANEB-001 to offer much-needed treatment for the increasing number of patients presenting to emergency departments with cannabinoid-related intoxication.

In addition to the FDA feedback, Anebulo has completed dosing in a Phase 2 clinical trial extension. This trial evaluated the safety and efficacy of ANEB-001 at higher challenge doses of THC. The trial included twenty healthy adult volunteers split into two cohorts. Cohort 7 received a combination of a single oral dose of 40 mg THC and 10 mg ANEB-001, while Cohort 8 received 60 mg THC and 20 mg ANEB-001. The earlier Part B of the study had shown that a single dose of 40 mg THC without ANEB-001 wasn't well-tolerated due to strong THC-related effects. However, the Institutional Review Board (IRB) approved higher THC challenge doses as long as all subjects also received ANEB-001. Part C was conducted as an open-label study without a placebo arm.

Preliminary observations indicated that the combination of THC challenge doses (40 mg and 60 mg) with ANEB-001 was well-tolerated, with mild and transient treatment-related adverse events. Comprehensive safety, pharmacokinetic (PK), and pharmacodynamic data, as well as results at higher THC doses, are expected in the fourth quarter of 2023.

Ken Cundy, Chief Scientific Officer of Anebulo, explained that Part C of the study aimed to provide insights into ANEB-001's potential efficacy and safety in real-world emergency situations by subjecting individuals to even higher THC doses than those in Parts A and B. The collaboration with the Centre for Human Drug Research in the Netherlands continues, and further results of this open-label study are anticipated.

Additionally, Anebulo is conducting an observational PK study involving patients reporting to the emergency department with ACI. The data collected from these studies will contribute to a better understanding of THC exposures associated with ACI and the potential of ANEB-001 treatment.

The Phase 2 study of ANEB-001 consisted of Parts A, B, and C, and was conducted under the oversight of the Centre for Human Drug Research (CHDR) in the Netherlands. A total of 134 healthy participants were enrolled in the study, each receiving oral THC challenge doses. Among them, 91 subjects were administered single oral doses of ANEB-001. The study evaluated pharmacodynamic effects using mixed-effect model repeated measures analysis of covariance, covering up to 8 hours post-ANEB-001 dosing. Safety was monitored through continuous observation for 24 hours, followed by a subsequent follow-up within 7 to 14 days post-treatment. Notably, the study found ANEB-001 to be well-tolerated, with no reports of serious adverse events.

At the 30 mg THC dose, participants displayed mild to moderate THC-related symptoms prior to ANEB-001 or placebo dosing. These symptoms included moderate euphoria, nausea, vomiting, and mild effects like bradyphrenia, dizziness, paresthesia, and emotional changes. Following delayed dosing of either 10 mg ANEB-001 or placebo after a 21 mg or 30 mg THC challenge dose, ANEB-001-related adverse events were mostly mild, except for one instance of moderate nausea/vomiting at THC doses of 21 mg and 30 mg. Notably, dizziness and euphoria were more prevalent in placebo-treated subjects. The administration of a high-fat meal delayed THC absorption, leading to reduced effects of a 30 mg THC dose on various outcomes. However, even with delayed dosing, 10 mg ANEB-001 significantly decreased VAS feelings of being high in subjects who consumed a high-fat meal.

ANEB-001, the primary candidate, is a potent small molecule cannabinoid receptor antagonist designed to address the urgent need for a specific antidote for acute cannabinoid intoxication (ACI). The compound is orally bioavailable and rapidly absorbed, with the aim of swiftly alleviating key symptoms of ACI. ANEB-001 is safeguarded by a patent and a patent application that covers its diverse applications and delivery systems. The Phase 2 proof-of-concept trial for ANEB-001 was initiated in December 2021 in the Netherlands. Positive Phase 2 Part A topline data were disclosed on July 5, 2022, followed by positive Part B data on September 26, 2022. By mid-December 2022, dosing for all subjects was completed, with preliminary Part B data unveiled on January 9, 2023. Complete results from both Part A and Part B of the Phase 2 clinical trial were reported on March 28, 2023. In July, a Type B meeting was held with the FDA to discuss the data and potential approval pathways, with formal minutes received on August 17, 2023. In tandem with the study extension (Part C), an observational study targeting ACI patients in Emergency Departments is currently ongoing. This study aims to establish cannabinoid and metabolite concentrations in plasma while gathering insights into signs, symptoms, patient disposition, and subjective assessments.

ACI symptoms encompass heightened somnolence, impaired cognition, disorientation, anxiety, and acute psychosis. Diagnosis entails recent cannabinoid use combined with significant behavioral or psychological changes following exposure, such as anxiety, panic attacks, impaired motor skills, and elevated heart rate.

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