Incannex’s CannQuit-N™, CannQuit-O™, and Renecann™: QPS to Help Advance Innovative Products Across USA and EU

Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL), a pharmaceutical company focused on developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies, is thrilled to announce the appointment of Quest Pharmaceutical Services (QPS) to provide regulatory advice and manage clinical trials for the development of CannQuit™ and ReneCann™ products. These products are targeted to address addiction and immune-disordered skin diseases, and could offer invaluable solutions for those in need.

QPS has come a long way since its founding in 1995, when it began as a small bioanalysis shop with only three people. Today, QPS is a global leader in the industry with more than 1,250+ employees in the United States, Europe, India, and Asia.

The company has evolved and now offers an even wider range of services, including Neuropharmacology, DMPK, Toxicology, Translational Medicine, Early Phase Clinical Research and Phase II – IV Clinical Research. With its commitment to providing high-quality bioanalytical LC-MS/MS contract services, QPS continues to be a trusted partner and innovator in the life sciences industry.

QPS is on the brink of launching its revolutionary CannQuit™ and ReneCann™ Products, and is currently in the process of drafting pre-IND submissions for both the EMA and the FDA. Upon receiving the necessary advice from the regulators, QPS will be in charge of managing the clinical trials that will prove the safety and efficacy of these products. This is an exciting opportunity to make a difference in the lives of those affected by addiction and chronic pain.

QPS is the ideal partner for us to bring our products to the world. With their expertise in clinical research and regulatory guidance, we’ll be able to quickly move our products to commercialisation across the globe. Joel Latham, CEO and Managing Director of the company, is confident that this collaboration will be a success.

APIRx Pharmaceuticals was acquired by Eurofins in 2022, granting them access to the patent-protected CannQuit™ and ReneCann™ products. Developed and manufactured by Eurofins Scientific, the products’ quality and stability will be monitored and included in future regulatory packages. This acquisition marks a major milestone in Eurofins’ journey to providing safe and effective nicotine cessation products.

CannQuit-Nicotine (N)

Eurofins is developing and testing a revolutionary medicated chewing gum formulation that combines the power of cannabidiol (CBD) and nicotine in a controlled-release, pharmaceutical-grade (cGMP) form. Get ready for a functional, effective, and truly innovative way to benefit from the therapeutic potential of both compounds!

CannQuit-N™, the world’s first nicotine chewing gum with CBD, has the potential to revolutionize smoking cessation. Incannex believes that the patented combination of nicotine and CBD offers superior therapeutic outcomes when compared to nicotine gum alone.

This innovative product has the advantage of controlled and sustained release of active ingredients, making it a powerful solution to the global smoking epidemic. In 2020 alone, nicotine gum sales reached $US5.2B, demonstrating the potential for CannQuit-N™ to make a real impact.

CannQuit-Opiod (O)™

CannQuit-O™, a revolutionary, controlled-release medicated chewing gum formulation, is here to revolutionize the treatment of opioid addiction. Combining pharmaceutical-grade CBD and an opioid antagonist/agonist in a proprietary water-soluble chewable tablet, CheWell, the tablet is loaded with a high CBD dose and a special polymer composition that ensures faster onset and improved bioavailability.

Currently, stability evaluation is in progress for the pharmaceutical ingredients in CannQuit-O™, paving the way for a more efficient and effective treatment for addiction.

The opioid crisis has reached catastrophic levels in the United States and beyond. According to the journal Drug and Alcohol Dependence, the total cost of fatal opioid overdoses and opioid use disorder in the US in 2017 was a staggering $1.02 trillion.

A staggering $64 billion is spent annually on treatments for opioid use disorder, yet no major breakthroughs have been made in recent decades to effectively tackle this devastating issue. It is time to work together to find innovative solutions and put an end to this epidemic.

Renecann™

Incannex has developed their proprietary topical cannabinoid formulation, ReneCann™, to treat dermatological conditions caused by immune system disorders, such as vitiligo, psoriasis, and eczema. Combining Cannabigerol (‘CBG’) and CBD, this unique formulation has powerful anti-inflammatory properties without any psychoactive effects. Validated assays have been performed to analyze the APIs and formulation development is currently underway for Renecann, including a placebo.

A 6-week in-human proof of concept study conducted at the Maurits Clinic, The Netherlands, and led by renowned dermatologist Dr. Marcus Meinardi, MD, PhD, demonstrated the effectiveness of ReneCann™, a formulation created by APIRx.

Patients with vitiligo, psoriasis and atopic dermatitis experienced a 10%, 33% and 22% reduction in their respective disease scores respectively. The results are particularly significant for vitiligo, as the incidence of this skin condition is 0.5-1.0% of the global population and treatments for it are limited.

About Incannex Healthcare Limited

Incannex is revolutionizing the pharmaceutical industry with its innovative medicinal cannabis and psychedelic medicine therapies for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain.

This cutting-edge clinical stage development company is transforming the way medical conditions are treated, and is paving the way for a better future of healthcare.

Incannex is pursuing U.S. FDA approval and registration for each drug and therapy under development, with the potential to revolutionize the medical industry and offer major global economic opportunities to the company and its shareholders.

These treatments represent a breakthrough in care, as they have no, or limited, existing registered pharmacotherapy (drug) treatments available for the public. With successful clinical trials, these treatments could have a profound impact on the lives of many.

Incannex is a cutting-edge company listed on the Australian Stock Exchange (ASX) with stock code “IHL” and American Depository Shares on NASDAQ under code “IXHL”. The Company has a robust patent filing strategy in place for its products and therapies, and currently holds 19 granted patents and 30 pending patent applications. With the help of its medical and scientific advisory board and partners, Incannex is on its way to making a real difference in the health and wellness industry.

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