Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has secured the aid of Quest Pharmaceutical Services to provide regulatory advice and manage clinical trials for the development of CannQuit™ and ReneCann™ products for addiction and immune-disordered skin diseases in the US and EU.
IHL is targeting nicotine and opioid addiction with its CannQuit-N™ and CannQuit-O™ products, and dermatological conditions caused by disorders of the immune system, including vitiligo, psoriasis, and atopic dermatitis – otherwise known as eczema – with ReneCann™.
The company’s overall strategy is to target unmet medical needs with the development of proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies.
Quickest route toward commercialisation
“QPS is a perfect fit for us to develop these products across the globe,” Incannex Healthcare CEO and managing director Joel Latham said.
“Not only will QPS assist us with conducting clinical research, it has [also] been engaged to advise upon the quickest route to commercialising the products in different regulatory jurisdictions.”
QPS grew from a three person bioanalysis shop in 1995 to a high-quality bioanalytical contract service with more than 1,250 employees across the United States, Europe, India and Asia.
The company provides Neuropharmacology, DMPK, Toxicology, Translational Medicine, Early Phase Clinical Research and Phase II – IV Clinical Research on top of its original bioanalytical offering.
QPS is currently drafting pre-investigational new drug (pre-IND) submissions for both the European Union’s European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for IHL’s CannQuit™ and ReneCann™ Products.
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 to provide relevant evidence of safety and efficacy.