Incannex leading the way in Medicinal Cannabis Developments.

The global medical cannabinoid market expected to reach $44 billion by 2024

Chief Medical Officer Joseph Stauffer recently stated to Fortune 'I have better than usual line of sight into the requirement for medications for acute and chronic pain. And if I've learned one thing, it's this: Society needs new drugs and remedies that don't turn common ailments or routine health care procedures into unnecessary gambles.' By 'unnecessary gamble', Joseph is referring to the raging opioid addiction crisis that in 2019 contributed to two-thirds of America's 72,000 drug overdose deaths [1] and is predicted to claim over half million lives over the next decade.[2]

The need for effective and safe pain and disease management treatment is a substantial and pivotal force driving the medicinal cannabis market. In three years (2024), the cannabinoid market is predicted to reach $44 Billion.

Living with chronic pain or disease is debilitating. It is proven to contribute to long-term neurological consequences[3], it is also recognised as a significant public health issue, producing a significant economic and social burden.[4] With the prevalence of chronic pain conditions and limited treatment alternatives available, many patients have opted to take the gamble and try opioids with devastating effects. There is immense pressure for effective, safe therapies related to pain management. The increase in demand is due to a growing geriatric population and the prevalence of chronic disease; according to the World Health Organization (WHO), in 2015, cancer was the second leading cause of deaths worldwide, contributing to 8.8 million deaths globally.

Cannabinoids consist of organic chemical compounds which occur naturally in the plant Cannabis Sativa. In humans, these compounds act as pain-relieving molecules that diminish incoming pain signals, effectively providing the patient from long-term discomfort; making cannabinoids lucrative for pain management.[5] According to IMARC: In comparison with other treatment alternatives, cannabis is safer and has less severe side effects.[6]

When it comes to cannabis stocks, Incannex interests me in particular due to its substantial long-term growth potential [trading at $0.16 at the time of publishing this article]. Incannex [ASX: IHL] is paving the way in medicinal cannabinoid pharmaceutical products, with four products in clinical trials and recently partnered with Monash University.

Monash University Partnership:

Incannex partners with Monash University to conduct a world-first clinical trial: Psilocybin-assisted psychotherapy in the treatment of Generalised Anxiety Disorder. This world-first clinical trial will be led by Dr Paul Liknaitzky, with support from leading researchers and clinicians at Monash, across Australia, and internationally. The trial will recruit at least 72 patients and will include a number of major innovations in treatment approach and study design.

With support from leading psychedelic research groups internationally, this planned FDA-compliant clinical trial will be a world-first using psilocybin in the treatment of GAD.

Generalised Anxiety Disorder is a relatively common disorder with about 6-9% lifetime prevalence and about 3% 12-month prevalence in countries like Australia and the United States.[7]

"This trial, and the associated partnership between IHL and Monash University, represents a major leap forward for psychedelic research and development in Australia, and will have a substantial impact on the field globally," said Dr Liknaitzky who will be the Chief Principal Investigator of the trial.

"I'm heartened by the support of IHL, and their ethical approach to supporting scientifically independent and patient-focused treatment development. I'm inspired by our esteemed and brilliant research and clinical team at Monash, and the strong support from the University.

"Given the early yet highly promising results from other psilocybin trials for different conditions, this treatment – alongside innovations we will develop – may deliver a substantial step forward in the treatment of anxiety disorders." You can read more about the partnership here and here.

There is also the potential that Incannex could receive a Breakthrough Designation from the FDA, a classification given that can expedite the development of drugs intended to improve treatment of severe diseases substantially.

Clinical Trials:

Incannex has four products, all in current clinical trials. The products target four conditions, each with the substantial market size. The good news for stockholders is that there is a plethora of potentially good news to be released from now until the trials conclude, including submissions for FDA approval, patent applications and trial results. FDA registration is being sought and should it be received; it would place IHL in a coveted group of medicinal cannabis companies.

The Company began its medical cannabis development program in late 2018 and has rapidly expanded since with a range of cannabinoid oils and a cannabidiol inhaler now for sale under the Special Access Scheme through its distribution partner and major shareholder, Cannvalate.[8]

Potential FDA Emergency Use Authorisation for patients with Covid-19.

Incannex anticipates being granted an expedited Pre-IND meeting due to the Company's intention to submit an FDA Emergency Use Authorisation request for patients with COVID-19.

Positive In vivo results confirm the strong synergistic activity of IHL-675A to inhibit inflammation. SAARDS is caused by a hyper-inflammatory response to infections and has high patient mortality; a leading cause of mortality in patients with COVID-19. Other common infections that can lead to sepsis and SAARDS are lung (e.g. influenza), kidney, gut and skin infections.

Since June 2020, IHL has announced successful results on the anti-inflammatory potency of IHL-675A from four separate preclinical studies. Camargo will report these results to the FDA in a comprehensive information package, which will also outline future clinical development plans for IHL-675A.

Patents:

The expanded clinical program will create four novel products for which patents have been or are in the process of being filed.

Four products in clinical trials:

IHL-42X | OSA - Obstructive Sleep Apnea

Sleep disorders, including sleep apnea, have become a significant health issue in the United States. It is estimated that 22 million Americans suffer from sleep apnea.[9]

IHL-216A | TBI - Traumatic Brain Injury

TBI accounts for approximately 10 million deaths and hospitalisations annually in the world (Schuman et al., 2017), and there are currently no registered pharmaceutical agents approved for the treatment of TBI.[10]

IHL-675A | SAARDS - Sepsis Associated Acute Respiratory Distress Syndrome

The incidence of ARDS in adult patients with sepsis is about 6%–7% in Western countries. According to data of the Korean Study Group on Respiratory Failure, the incidence of sepsis-induced ARDS is 6.8% (306/4,515) in Korea (unpublished data).[11]

IHL-493C | TMJD - Temporomandibular Joint Dysfunction

We don't know for sure how many people have TMJ disorders, but some estimates suggest that over 10 million Americans are affected.[12]

Board members:

Each board member brings extensive experience to the Company, notably Dr SUD AGARWAL - Chief Medical Officer and Director. Dr Agarwal is considered one of the most influential people in the medicinal cannabis sector, as evidenced by being a recent keynote speaker at the World Cannabis Congress (held in Canada). He is also the current CEO of Cannvalate Pty Ltd, which is Australia's largest distributor of medicinal cannabis products. Before Impression Healthcare, Sud was the Medical Director of ASX-listed, Cann Group Limited. You can read more about the board here.

Currently, Incannex has many significant positive attributes in terms of long-term growth and developmental potential.

'There is nothing more powerful than an idea whose time has come.'

SOURCE: The Traders Edit - https://tinyurl.com/y93996b9