IHL-675A Reveals Promising Safety and Pharmacokinetic Profile, with Mark Bleackley, PhD


Results demonstrated IHL-675A was well-tolerated, with no concerning adverse events or serious adverse events reported.

IHL-675A is a combination drug candidate consisting of hydroxychloroquine sulfate (HCQ) and cannabidiol (CBD). HCQ, recognized as an essential medicine by the World Health Organization, was originally developed as an anti-malarial drug but is now used for its anti-inflammatory properties in treating conditions like rheumatoid arthritis (RA). CBD, approved for seizure disorders, is commonly used as an unregistered therapy for RA.

The mechanism of action involves HCQ interfering with antigen presentation and lysosomal acidification, while CBD modulates the activity of inflammatory signaling receptors. Preclinical studies have demonstrated anti-inflammatory synergy between the two drugs, establishing a robust intellectual property (IP) position for the IHL-675A drug candidate. This combination therapy holds promise for addressing various inflammatory conditions based on its dual mechanism of action.

Given the established use of the individual active pharmaceutical ingredients in treating RA, IHL-675A emerges as a strong candidate for RA treatment. Additionally, it shows potential for addressing other inflammatory conditions such as inflammatory bowel disease, chronic obstructive pulmonary disease (COPD), and asthma.

In an interview with HCPLive, Mark Bleackley, PhD, Chief Scientific Officer of Incannex Healthcare Limited, discussed the IHL-674A phase 1 clinical trial results.

Incannex conducted a Phase 1 clinical trial to assess the safety, tolerability, and pharmacokinetics of IHL-675A. The trial focused on key endpoints such as adverse events and plasma levels of active pharmaceutical ingredients (APIs), CBD and HCQ, and their major metabolites over a 28-day period. IHL-675A was compared to reference drugs, Epidiolex and Plaquenil, for CBD and HCQ, respectively. The trial included three cohorts with a total of 36 participants, and all groups were evaluated equally.

The results indicated that IHL-675A was well-tolerated, with no concerning adverse events or serious adverse events reported. The number of treatment-related treatment emergent adverse events (TEAEs) for IHL-675A was comparable to Epidiolex.

Pharmacokinetic trends suggested that the uptake of CBD might be faster for IHL-675A compared to Epidiolex, and the uptake of HCQ could be slower for IHL-675A than Plaquenil. This potential advantage for IHL-675A as a drug product implies that CBD may offer accelerated relief for inflammation and pain, while HCQ, being slower-acting, might provide extended relief. These findings provide promising insights into the safety, tolerability, and pharmacokinetics of IHL-675A, paving the way for further developments in its potential therapeutic applications.

Disclosures: Bleakley is a shareholder at Incannex.

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