Positive results from Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL)’s ongoing Australian Phase II Psi-GAD1 study would represent a significant catalyst for the company, according to Edison Investment Research.
It is estimated that around 6.8 million US adults (~3% of the US population) suffer from GAD (generalised anxiety disorder), representing a significant patient population.
Edison expects management to use the results of the Psi-GAD1 trial, assuming they are positive, to support potential Phase II FDA-approved studies in FY23.
The investment research firm continues to value Incannex at US$736.6 million or US$11.7 per ADR, including the issued shares from the A$13 million private placement in December 2022. Incannex ADRs are currently trading at US$3.5 per ADR.
The following is an extract from the research update:
Following continued patient enrolment in Incannex’s ongoing Australian Phase II Psi-GAD1 study (ACTRN12621001358831), management has announced the commencement of an independent analysis of the interim data. The company expects the interim results from the study of psilocybin-assisted psychotherapy in generalised anxiety disorder (GAD) to be reported in March 2023. In our view, positive results would represent a significant catalyst for Incannex, considering the large GAD patient population (c 6.8 million US adults), lack of consistently effective first-line treatments and safety issues associated with long-term medication. We expect management to use the results of the Psi-GAD1 trial, assuming they are positive, to support potential Phase II FDA-approved studies in FY23. We continue to value Incannex at US$736.6m or US$11.7 per ADR, including the issued shares from the A$13m private placement in December 2022.
The ongoing Australian Phase II Psi-GAD1 study is a triple-blind, active placebocontrolled trial to assess the safety, efficacy and tolerability of psilocybin-assisted psychotherapy in patients with GAD. A team of experienced clinicians is conducting the Psi-GAD1 trial at the globally recognized Monash University’s BrainPark. The study aims to recruit a total of 72 patients (30 in Phase IIa, 42 in Phase IIb) and, when interim analysis commenced, it had enrolled 45 participants with 29 having completed the 10-week treatment protocol. The interim analysis will be conducted by an independent Data Safety Monitoring Board formed of subject experts. Incannex’s management intends to use the interim analysis to make key decisions on regulatory strategy and potential pivotal studies.
Psilocybin is a naturally occurring psychoactive compound which, in combination with psychotherapy, management believes could be an effective treatment for GAD. It is estimated that around 6.8 million US adults suffer from GAD (c 3% of the US population), representing a significant patient population. First-line treatment for GAD is often psychotherapy followed by medications, including anti-depressants, pregabalin (an anxiolytic) and benzodiazepines (tranquilisers). However, c 50% of patients treated for GAD will not respond to first-line treatment and long-term use of existing medications may result in adverse side effects including dependence, irritability and dizziness. Therefore, we believe the GAD treatment market represents a significant opportunity for Incannex, should results from Psi-GAD1 prove positive.