Incannex has made a key appointment as it works to advance its CannQuit-N (Nicotine), CannQuitO (Opioid) and Renecann products in the USA and EU.

Medicinal cannabis and psychedelic therapies company, Incannex Healthcare (ASX: IHL) has announced that it has appointed Quest Pharmaceutical Services (QPS) to provide regulatory advice and manage clinical trials for the development of its CannQuit and ReneCann products for addiction and immune-disordered skin diseases.

QPS was founded in 1995 to provide high-quality bioanalytical LC-MS/MS contract services and has grown from a small molecule bioanalysis shop of three people to more than 1,250+ employees in the US, Europe, India, and Asia.

Over the years, QPS has adopted additional services, including neuropharmacology, DMPK, toxicology, translational medicine, early phase clinical research and phase-2 through to phase-4 clinical research.

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 the CannQuit and ReneCann products.

Once advice from the regulators is received, QPS will retain a leading role in the management of clinical trials, which will be undertaken to provide relevant evidence of safety and efficacy.

CannQuit-NTM aims to improve outcome of nicotine-only gum

CannQuit-Nicotine (N) is a  controlled-release, pharmaceutical-grade (cGMP) medicated chewing gum formulation comprising cannabidiol (CBD) and nicotine.

Nicotine chewing gum is already an  accepted treatment and maintenance product throughout the globe with annual sales amounting to US $5.2 billion in 2020, however, progression to complete smoking cessation is limited.

By adding CBD in a proprietary combination, CannQuit-N is hypothesised by IHL to improve upon the therapeutic outcomes of nicotine only gum.

Eurofins was appointed in November 2022 to manufacture IHL’s medicated chewable products designed to treat nicotine and opioid addiction disorders.

CannQuit-Opiod (O) to tackle critical opioid addiction

CannQuit-Opioid (O) is a controlled-release, pharmaceutical-grade medicated chewing tablet formulation combining CBD and an opioid antagonist/agonist in a proprietary water-soluble chewable tablet for the treatment of opioid addiction.

The water-soluble chewable tabletis uniquely loaded with a high CBD dose and in addition the unique polymer composition that ensures faster onset and higher bioavailability. At present, stability evaluation is being done for the pharmaceutical ingredients within CannQuit-O.

The opioid epidemic has reached critical levels in the US and the industrialised world.

Fatal opioid overdoses and opioid use disorder cost the US $1.02 trillion in 2017, as measured by the Centre for Disease Control (CDC) in the journal Drug and Alcohol Dependence, which is the most complete accounting of America’s opioid crisis to date.

Treatments for opioid use disorder total US$64 billion annually and there have been no major new treatment solutions in recent decades.

ReneCann to provide relief from common skin conditions

ReneCann is IHL’s proprietary topical cannabinoid formulation for treatment of dermatological conditions caused by disorders of the immune system, including vitiligo, psoriasis, and atopic dermatitis, otherwise known as eczema.

The unique formulation combines Cannabigerol (CBG), a non-psychoactive cannabinoid with potent anti-inflammatory properties, and CBD.

A previous version of ReneCann was formulated by US-based APIRx Pharmaceuticals, which IHL acquired in 2022.

The study was conducted at the Maurits Clinic, The Netherlands, and led by a world-renowned dermatologist Dr Marcus Meinardi.

In the study, ReneCann reduced disease scores in patients with each of the target skin diseases.

Patients with vitiligo, psoriasis and atopic dermatitis were observed to experience improvements in symptoms of 10%, 33% and 22% respectively.

IHL said, the results for study participants with vitiligo were encouraging because the incidence of the disease is high at 0.5-1.0% of the global population with limited treatments.

QPS engagement to fast-track commercialisation

 IHL CEO and managing director Joel Latham said QPS was a perfect fit for the company to develop and commercialise the products globally.

“Not only will QPS assist us with conducting clinical research, but it has also been engaged to advise upon the quickest route to commercialising the products in different regulatory jurisdictions,” he said.

“The CannQuit and ReneCann products are patent protected and were acquired as part of the acquisition of APIRx Pharmaceuticals completed in 2022.”

He said data collected by Eurofins during development manufacturing on the quality and stability of the products will be key components of future regulatory packages aimed at achieving commercialisation.

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.