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- Incannex (IHL) appoints Quest Pharmaceutical Services (QPS) to provide regulatory advice and manage its clinical trials for its patented drugs, CannQuit and ReneCann
- QPS is drafting pre-investigational drug submissions for the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)
- The IHL proprietary drugs are designed to treat addiction and immune-disordered skin diseases
- The products are being developed and manufactured by Eurofins Scientific, which is monitoring the quality and stability of the products
- IHL shares are down 4 per cent to 12 cents at 10:12 am AEST
Incannex (IHL) has appointed Quest Pharmaceutical Services (QPS) to provide regulatory advice and manage the company’s clinical trials for its CannQuit and ReneCann medicinal cannabinoid products.
The IHL proprietary drugs are designed to treat addiction and immune-disordered skin diseases, and QPS will provide high-quality Bioanalytical LC-MS/MS contract services to support the development of the new drugs.
QPS is currently drafting pre-investigational drug submissions for the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
IHL said the trials would provide relevant evidence of the safety and efficacy of its investigational drugs.
“QPS is a perfect fit for us to develop these products across the globe; not only will QPS assist us with conducting clinical research, it has been engaged to advise upon
the quickest route to commercialising the products in different regulatory jurisdictions,” IHL CEO and Managing Director Joel Latham said.
Once advice is received from the regulators over the proposed research and
development programs, QPS will retain a leading role in the management of clinical trials.
The CannQuit and ReneCann products are patent protected and were acquired as part of the company’s acquisition of APIRx Pharmaceuticals (APIRx) in 2022.
These products are being developed and manufactured by Eurofins Scientific (Eurofins), which will collect data on the quality and stability of the products.
IHL shares were down 4 per cent to 12 cents at 10:12 am AEST.
