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Mark Bleackley, PhD, discusses the upcoming phase 2 trial of IHL-675A designed to explore arthritis treatment through dual-drug comparison, promising global expansion, and its impact on patients’ pain relief.
In the second part of an interview with HCPLive, Mark Bleackley, PhD, Chief Scientific Officer of Incannex Healthcare Limited, discusses the upcoming phase 2 comparing IHL-675A, a combination drug candidate consisting of hydroxycholoroquine (HCQ) and cannabidiol (CBD), to its component drugs for the treatment of rheumatoid arthritis (RA).
To maintain the blind, Bleackley and his team created identical drug products with only CBD or only hydroxychloroquine. The study also includes a placebo arm, making it a 4-arm study: IHL-675A, CBD, hydroxychloroquine, and placebo. This comparison will span a 6-month treatment period, with the primary endpoint being a change in a score called Routine Assessment of Patient Index Data 3 (RAPID3), a composite endpoint monitoring pain and function. The study involves 128 patients and will collect data at various instances over the treatment period.
The team is also gathering data on other disease aspects, using established arthritis patient-reported outcomes and examining physiological outcomes, particularly inflammatory markers. Daily patient diaries will track joint stiffness and pain, emphasizing the patient's experience, and is currently underway in Australia in 10 sites.
Bleackley explained there are several advantages to conducting the study in Australia, including significant tax incentives for research and development. While considering running the next study with sites in the US, the current focus is on building proof of concept in Australia.
Eventually, the plan is to include US sites in the next phase, which will provide an opportunity for US patients to enroll. They are eagerly anticipating understanding how IHL-675A behaves in patients with RA. The potential for a lasting and meaningful impact on patients, particularly in alleviating pain, is promising based on preclinical studies.
“We are looking forward to getting the study into full swing and starting to collect some data,” Bleackley concluded. “It is always hard waiting for the results to come through but it is really rewarding when it does. We are excited to keep going on that journey moving towards investigational new drug (IND) and opening a study in the US in the in the near future.”
Disclosures: Bleakley is a shareholder at Incannex.