Specialised pharmaceutical manufacturer Procaps SA has been engaged by Incannex Healthcare (ASX: IHL) to develop the specific formulation for its drug IHL-675A using Procaps’ Unigel capsule technology.
Under the terms of the deal, Procaps will provide an end-to-end service for Incannex which will include formulation development for IHL-675A, clinical trial supply and commercial manufacture of the drug on receipt of positive trial outcomes.
The process will be supported by Procaps’ intellectual property portfolio, providing access to a range of formulation and manufacturing technologies for the finished product.
This will include the company’s patented Unigel technology for delivering solid dosage drugs within soft gelatin (softgel) capsules.
The innovation allows for different configurations for fixed-dose medicines, such as a softgel within a softgel, one or two tablets within a softgel, granules within a softgel or any combination of these to accommodate multi-active formulations.
Incannex chief executive officer Joel Latham said Procaps would offer a complete supply chain solution for Incannex’s “sophisticated, GMP-grade product”.
“Manufacturing at Procaps will support our clinical trial programs and can also quickly ramp up production for commercial supply once we achieve successful outcomes,” he said.
Who is Procaps?
Procaps has developed over 500 formulations for pharmaceutical and nutritional products in more than 50 markets globally.
It is the largest integrated contract development and manufacturing company in Latin America and is ranked within the top three companies globally for soft gel manufacturing capacity.
Procaps’ manufacturing plants have been inspected and approved for good manufacturing practices (GMP) by agencies including the US Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), Health Canada and the UK’s Medicines and Healthcare Products Regulatory Agency.
IHL-675A comprises hydroxychloroquine (HCQ) and cannabidiol (CBD) which act synergistically to inhibit the production of key inflammatory cytokines.
The combination has been demonstrated by Incannex to work in vitro and in vivo to reduce disease severity in three established inflammatory disease animal models.
Earlier this year and after an FDA pre-IND meeting, Incannex expanded its development program to assess the potential of IHL-675A to become a multi-use pharmaceutical drug applicable to the indications of rheumatoid arthritis, inflammatory bowel disease and lung inflammations such as acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disorder (COPD), asthma and bronchitis.
Rheumatoid arthritis potential
In March, Incannex revealed results from its pre-clinical in vivo study, which showed IHL-675A has a benefit in treating rheumatoid arthritis superior to either HCQ or CBD alone.
HCQ is currently used to treat rheumatoid arthritis under the drug name Plaquenil.
The research indicated IHL-675A could permit a 10 times reduction in the HCQ dose when combined with CBD, without sacrificing efficacy.
Incannex noted this reduction for a similar efficacy may entail lower side effects and is an exciting opportunity for the company to investigate. Rheumatoid arthritis has a global annual address market size exceeding US$57 billion.
Phase 1 trial
Incannex is advancing its plans for a phase 1 clinical trial to assess IHL-675A softgel capsules in healthy volunteers.
The trial aims to demonstrate that there are minimal or nil additional side effects associated with the HCQ-CBD combination compared to the use of each ingredient alone.
A total of 36 subjects will participate in the trial which will be evenly divided into three groups, each of which will receive IHL-675A, HCQ or CBD.
Safety and other pharmacokinetic assessments will be identical across the groups.
Trial results will be incorporated into US FDA investigational new drug applications for each of the three indications that Incannex is pursuing with IHL-675A.