Incannex share price races higher on 'pivotal' trial approval

This cannabis share is lighting up the market on Thursday.

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Researchers working with medical cannabis.

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The Incannex Healthcare Ltd (ASX: IHL) share price is on the move on Thursday.

In morning trade, the cannabis-focused pharmaceutical company's shares are up 4.5% to 12 cents.

Why is the Incannex share price rising?

Investors have been buying the company's shares today after it released an update on a clinical trial.

According to the release, Incannex has received approval from Bellberry Human Research Ethics Committee (HREC) for the lead site, Emeritus Research in Melbourne, for its Phase 2 clinical trial.

Management notes that the trial is pivotal in nature and will assess the safety and efficacy of IHL-675A in patients with rheumatoid arthritis (RA). IHL-675A is the company's proprietary anti-inflammatory combination drug product.

This trial follows the successful phase 1 clinical trial, whereby both active pharmaceutical ingredients, cannabidiol (CBD) and hydroxychloroquine sulphate (HCQ) were absorbed using IHL-675A. The drug product was also observed to be well tolerated, with no adverse events of concern.

What is phase 2?

The phase 2 study aims to build on the above and will assess the efficacy, safety, and tolerability of IHL-675A compared to the respective component active pharmaceutical ingredients (APIs), CBD and HCQ, and placebo.

As the treatments will be double-blinded, this means neither the investigators nor patients will know which treatment an individual is receiving.

Management notes the results of the trial will establish the safety and efficacy of IHL-675A in RA and will be a critical component of future regulatory applications. This includes contributing to the combination rule assessment in the US FDA's new drug application dossier.

Incannex Chief Scientific Officer Dr Mark Bleackley said:

HREC approval for the Phase 2 clinical trial is a key step in the development of IHL-675A for treatment of pain and reduced function associated with rheumatoid arthritis. We look forward to working with Emeritus and Avance to assess the effect of IHL675A in this patient population.

It is worth noting that Incannex announced plans to leave the ASX earlier this week. It plans to move its listing to the Nasdaq later this year.

Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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