Incannex has engaged Procaps to develop and manufacture its IHL-675A soft-gel capsules in preparation for clinical trials.

The company’s anti-inflammatory multi-use drug product will be developed with Procaps’ ́proprietary patented Unigel technology.

Incannex Healthcare (ASX:IHL) has essentially secured an end-to-end service that includes formulation development, clinical trial supply and subsequent commercial manufacture.

Not to mention that Procaps’ manufacturing plant has been inspected and approved for good manufacturing practices (GMP) by multiple regulatory agencies including FDA, TGA, Health Canada and MHRA.

The company is now focused on assessing the potential of IHL-675A to become a multi-use pharmaceutical drug applicable to lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, and inflammatory bowel disease.


Complete supply chain solution

Procaps has developed over 500 formulations for both pharmaceutical and nutritional products reaching over 50 markets globally and is the largest integrated contract development and manufacturing company in Latin America

“Procaps offers Incannex a complete supply chain solution for a sophisticated, GMP-grade product,” Incannex CEO and managing director Joel Latham said.

“Manufacturing at Procaps will support our clinical trial programs and can also quickly ramp up production for commercial supply upon successful clinical trial outcomes.”


Rheumatoid arthritis animal model results

In March the company released results from its rheumatoid arthritis tests on laboratory rats, which demonstrated that IHL-675A components – hydroxychloroquine (HCQ) and cannabidiol (CBD) – act synergistically to inhibit production of key inflammatory cytokines both in vitro and in vivo and reduce disease severity in three established inflammatory disease animal models.

The results showed that IHL-675A has a benefit in the treatment of rheumatoid arthritis greater than that of CBD or HCQ alone.

The treatment has the potential to permit a 10-fold reduction in HCQ dose, without sacrificing efficacy – which may result in a lower side effect profile for patients.


Clinical trial plans

The next step is a Phase I clinical trial to assess IHL-675A soft gel capsules in healthy volunteers, with a total of 36 subjects to receive either one of IHL-675A, CBD, or HCQ.

Subject to clinical success, the results of the Phase I clinical trial will form part of three FDA investigational new drug (IND) applications for each indication the company is pursuing with IHL-675A.

Once the IND applications are evaluated and approved, the company intends to conduct Phase II and III clinical trials partly or wholly in the United States.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.