Anebulo Pharmaceuticals ANEB was up almost 10.4% on Monday, after receiving a positive FDA response following a Type B meeting held in July related to its lead candidate ANEB-001. The FDA’s positive feedback marks a step forward for Anebulo that will enable it to move forward with the design and execution of phase III study for ANEB-001.

ANEB-001 is currently being evaluated in a phase II proof-of-concept for treating patients suffering from acute cannabinoid intoxication (ACI). This candidate is a small molecule cannabinoid receptor antagonist that has the potential to alleviate symptoms of ACI.

During the meeting, the FDA suggested that the single well-controlled study of ANEB-001 in ACI patients who arrive at the emergency room, along with a larger study involving THC challenges in enrolled patients, could potentially support the new drug application for ANEB-001.

This promising feedback from the FDA marks a crucial step forward for Anebulo, enabling it to move forward with the design and execution of phase III study for ANEB-001.

ACI episodes are a growing concern in the United States, especially in states where cannabis have been legalized for medical and recreational use. These episodes often result from consuming large amounts of THC, the primary psychoactive component in cannabis. If ANEB-001 is approved, it could be the first FDA-approved treatment to reverse the effects of THC.

Anebulo's shares have rallied 27.5% year to date against the industry's 13.1% decline.

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The company also completed dosing patients in an open-label part C portion of the phase II study, which is evaluating the safety and efficiency of ANEB-001at higher challenge doses of THC. The part A and part B of the study were completed earlier in March.

Data from part A of the study showed positive protective effects of a single oral dose of 50 or 100 mg ANEB-001 when co-administered with an oral challenge dose of 10.5 mg THC.

Part B of the study showed that a single low oral dose of ANEB-001 (10 mg), when administered an hour after a THC challenge, effectively and significantly reversed key psychotropic effects induced by THC doses as high as 30 mg.

Furthermore, Anebulo is conducting an observational pharmacokinetic (PK) study in patients reporting to the emergency department with ACI. Data from both the part C extension and the observational PK study will help the company better understand THC exposures related to ACI.

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