The Rise of Cannabinoid Therapeutics. A look into Revive Therapeutics & Kalytera Therapeutics.

Cannabinoid Therapeutics: A Game Changer

The rise of canadian cannabis stocks took the market by surprise in late 2016 and now 2017. This massive momentum in the industry was based of the speculation that the  liberal party will legalize and regulate cannabis in canada. This speculation gave licensed producers being publicly traded a  major rise in share price. The task force report played an important role and from now on till legalization is solidified any news on the progression of legalization will act as a catalyst.

But there is something else on the horizon something potentially bigger than the medical and recreational cannabis market and that something is cannabinoid based pharmaceuticals, cannabinoid prodrugs and novel cannabinoid therapies specifically targeting important diseases and disorders. Sure any mom and pop shop can extract CBD from cannabis plant material, market it and sell it. But what most consumers don’t know is CBD has a poor oral bioavailability, the clinical studies done showing all the wondrous effects of CBD & cannabinoids from cannabis required large dosages in clinical settings. CBD is wide spectrum miracle compound, but it has downsides like poor oral bioavailability and requires large doses. This is where Revive Therapeutics and Kalytera Therapeutics comes in, they as working to produce novel compounds and prodrugs to combat the problems of bioavailability , specific targeting of diseases and dosing.

 

Revive Therapeutics

 

Revive Therapeutics Ltd. (TSX-V: RVV) (OTCQB: RVVTF) is focused on the research, development and commercialization of novel treatments for serious and unmet medical needs.   Revive’s drug discovery approach combines bioinformatics and drug development relationships with leading researchers and institutions.  Revive targets opportunities by identifying and investigating potential drugs and plant-based therapies, such as cannabinoids, that may be repurposed for new indications, be delivered in a different way, or be developed as new chemical entities.

 

 

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The Cannabinoid Opportunity

 

Cannabinoids, such as THC and CBD, derived from cannabis bind to receptor sites CB-1 (brain) and CB-2 (body) having potential to treat a number of disorders including inflammation, pain, nausea, cancer, metabolism, neurological, etc.

Over 70 cannabinoids identified and unlike new drug development, cannabinoids may offer a lower risk development opportunity – established safety and potential efficacy

Currently there are three Cannabinoid products approved in US or EU: Sativex™ (GW Pharma), Marinol™ (AbbVie), Cesamet™ (Meda)

GW Pharma – cannabinoid focused; over USD $3 billion market cap

21st Century Cures Act to accelerate Cannabinoid drug development offering a significant untapped opportunity

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Kalytera Therapeutics

 

Kalytera (TSXV: KALY) is pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of novel cannabinoid medicines for a range of important unmet medical needs.

Kalytera is focused first on developing a new class of proprietary cannabidiol (“CBD”) therapeutics. CBD is a remarkable compound that has shown activity against a number of pharmacological targets. However, there are limitations associated with natural CBD, including its poor oral bioavailability and short half-life. Kalytera is developing innovative CBD formulations and prodrugs in an effort to overcome these limitations, and to target specific disease sites within the body. Kalytera intends to file composition of matter and method of use patents covering its novel inventions, with the goal of limiting future competition.

 

 

 

 

Kalytera’s Development Strategy:

 

  • Non-Psychoactive Cannabinoid Products

    To expedite regulatory approval and commercialization, Kalytera intends to explore the use of CBD, a non-psychoactive cannabis constituent. A large body of research supports CBD’s safety profile.

  • Proprietary Analogues of Cannabis-like Molecules

    Kalytera seeks to advance a portfolio of synthetic, non-psychoactive cannabis-like molecules. By modifying cannabinoid molecules, and molecules which regulate the endogenous cannabinoid signaling system, Kalytera seeks to improve pharmacokinetics and increase potency, potentially allowing for the development of drug candidates with improved activity.

  • Focus on Orphan Conditions

    Kalytera will also focus on orphan conditions, with the goal of generating data in humans that may support follow-on studies in major conditions. Orphan designations often carry additional terms of marketing exclusivity and procedures to accelerate regulatory approvals.

 

GVHD

 

Prodrugs

  • K-1012
    Therapeutic goal and molecular design K-1012 is a novel prodrug invented by Kalytera Therapeutics, intended for the treatment of Adult respiratory distress syndrome (ARDS). Designed as a bi-phosphate derivative of cannabidiol (CBD), K-1012 will be administrated intratracheally via a novel formulation expected to increase the bioavailability of CBD, known for its immunosuppressive and anti-inflammatory properties.

 

  • K-1022
    Therapeutic goal K-1022 is a novel prodrug invented by Kalytera Therapeutics, intended for the treatment of Ulcerative Colitis (UC), a chronic condition characterized by inflammation of the colonic mucosa extending from the rectum proximally to varying portions of the large intestine. The increase in pro-inflammatory factors promotes inflammation and facilitates damage to intestinal tissues. Understanding the pathophysiology of colitis has provided us an opportunity to identify new targets for this disease. The active parent compound of K-1022, CBD, is known for its immunosuppressive and anti-inflammatory properties.

 

  • K-1032
    Therapeutic goal K-1032 is a novel prodrug invented by Kalytera Therapeutics, intended for the treatment of the chronic skin diseases Atopic dermatitis (AD) and Acne Vulgaris. K-1032 is the L-valine-ester derivative of CBD. AD is a chronic disease of the skin caused by skin barrier dysfunction, which together with environmental factors and immune system variability, leads to eczematous and itchy lesions at the flexural folds. Acne is a chronic inflammatory disease of the sebaceous-pilosebaceous unit. Acne vulgaris is the most common skin disease, affecting 45 million people in the USA; nearly 80 percent of adolescents present with acne. Progressive AD and acne are closely linked to activation of inflammation. CBD, is known for its immunosuppressive and anti-inflammatory properties, which has been demonstrated in rodent models of arthritis via transdermal application. Thus, we elect K-1032 as novel candidate for the treatment of AD and acne, which we anticipate to suppress the inflammation present in both chronic skin diseases.

 

  • K-1042
    Therapeutic goal K-1042 is a novel prodrug invented by Kalytera Therapeutics, intended for the treatment of Acute renal failure (ARF). Designed as a boronic acid derivative of cannabidiol (CBD), K-1042 is being developed to improve the long-term outcome of ARF patients. ARF is a syndrome characterized by rapid loss of kidney function, specifically the glomerular filtration rate, measured by increases in serum creatinine and limited or lack of urine output. ARF is a common complication of acute illness, affecting more than 35% of critically ill patients. Despite advances in treatment and prevention, ARF continues to be associated with high rates of mortality and morbidity, particularly for patients admitted to the intensive care unit (ICU), where mortality rates can exceed 50%. Various types of injury lead to ARF. Common to all these injuries is an inflammatory response due to the kidney insult. The active parent compound of K-1042, CBD, is known for its immunosuppressive and anti-inflammatory properties. Thus, we elect K-1042 as novel candidate for the treatment of ARF, which we anticipate to suppress the inflammation present in ARF patients and prevent long-term kidney failure.

 

  • K-1042
    Therapeutic goal K-1042 is a novel prodrug invented by Kalytera Therapeutics, intended for the treatment of Acute renal failure (ARF). Designed as a boronic acid derivative of cannabidiol (CBD), K-1042 is being developed to improve the long-term outcome of ARF patients. ARF is a syndrome characterized by rapid loss of kidney function, specifically the glomerular filtration rate, measured by increases in serum creatinine and limited or lack of urine output. ARF is a common complication of acute illness, affecting more than 35% of critically ill patients. Despite advances in treatment and prevention, ARF continues to be associated with high rates of mortality and morbidity, particularly for patients admitted to the intensive care unit (ICU), where mortality rates can exceed 50%. Various types of injury lead to ARF. Common to all these injuries is an inflammatory response due to the kidney insult. The active parent compound of K-1042, CBD, is known for its immunosuppressive and anti-inflammatory properties. Thus, we elect K-1042 as novel candidate for the treatment of ARF, which we anticipate to suppress the inflammation present in ARF patients and prevent long-term kidney failure.

 

  • K-1062
    Therapeutic goal K-1062 is a novel cannabidiol (CBD)-based pharmaceutical composition invented by Kalytera Therapeutics, intended for the treatment Congestive Heart Failure (CHF). K-1062 is a di-nitrate-derivative of CBD. CHF is characterized by a rousing cardiac injury that triggers a cascade of neurohormonal responses, commonly associated with poor quality of life, frequent hospital admissions, and poor survival affecting approximately 26 million people worldwide (Arroll B et al., 2010), (Verschure DO et al., 2016).

 

More Information On Kalytera Produrgs & Source 

 

Ending Statements

 

Revive Therapeutics and Kalytera Therapeutics are on a path to become very strong companies, If they can execute. Revive Therapeutics is showing great promise with their drug pipeline, especially with bucillamine and now with their expansion into cannabinoid related therapies targeting liver disease &  potentially other diseases.  Kalytera Therapeutics is developing a amazing pipeline of prodrugs to target diseases that affect the heart, brain,lungs and kidneys. Kalytera Therapeutics is making great strides in Graft versus Host Disease with its novel compound and we can expect great things from them in the future.

 

Also not to mention that these companies could be targets of acquisitions by larger pharmaceutical companies. These stocks are grossly undervalued with the potential they have, Revive Therapeutics has seen a massive surge in trading volume since February 17th 2017 and Kalytera has announced positive results on their phase two study on GvHD recently.  This stock has great potential and amazing things in the works, but they are not anywhere near ready to explode yet. These companies need to keep putting out positive results on their clinical studies and research new and novel compounds to expand their pipelines. Revive and Kaltera Therapeutics both have been averaging a cash burn rate of 100 k -200k a month, while having enough funds to get through the year. Both companies will need to raise further capital to continue on with their operations after 2017.

 

The companies need to do their best to raise capital , so it is my personal opinion that these companies will need to do future private placements to meet their capital needs. Short term this could reduce the overall share price, but these stocks are great long term picks that will prove to be very lucrative investments only if these companies can execute their vision with accuracy & in a timely manner.

 

 

Disclosure : We are long on Kalytera Therapeutics and hold no position in Revive Therapeutics.

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