Breakthrough results from new medical cannabis oil study

STENOCARE A/S
NASDAQ FIRST NORTH GROWTH MARKET, DENMARK
TICKER: STENO

STENOCARE A/S (“Stenocare”) today announces groundbreaking results from their study of a new medical cannabis oil formulation. The study shows that the new formulation dramatically enhances the bioavailability and thus uptake of cannabinoids, regardless of meal consumption and inter-individual biological differences. The findings may have the potential to formulate novel medical cannabis products with vastly improved characteristics in the treatment of chronical pain and a variety of indications and diseases.

THE PHARMACOKINETIC STUDY
The study announced today was a pharmacokinetic study completed at accredited pre-clinical contract research organizations in Scandinavia. The study revealed significant positive effects on dogs. The study administered two different product formulations of CBD 25 mg/mL oil by a single oral administration in a four-way cross-over design to dogs. Product A was CBD25 with MCT-oil, and product B was CBD25 with the new LTT-oil based upon Solural Pharma’s Lymphatic Targeting Technology (LTT). The CBD uptake was measured in the blood with these two different formulations in both a fasted and fed state. The MCT-oil (Medium-chain triglycerides) in Product A can be seen as a representative of the medical cannabis oil products on the European market today.

PAVING THE WAY TOWARDS PHARMA-GRADE MEDICAL CANNABIS
Generic medical cannabis products are available in several versions ranging from CBD (non-intoxicating), to THC and combinations of the two. These cannabinoids are mixed with standard oils like MCT-oil. Use of these standard oil products leads to unpredictable bioavailability which is ability of a drug or other substance to be absorbed and used by the body.

Challenge #1: Uptake
Low and inconsistent uptake of the drug in the blood across patients is a major and well-known challenge in the pharma industry, that applies to most drugs. This also applies to medical cannabis. Today, when patients are administrating traditional oil based medical cannabis, the metabolism will reduce the uptake of cannabinoids in the body. This means that a highly variable and often little part of the cannabinoids are actively delivered inside the patient with a therapeutic effect. This is creating problems to prescribe a steady dosage of the drug to patients. Also, the uptake in the blood is very different for each individual due to biological differences between patients.

What the study concludes:

• Improves uptake in the blood with a factor 2.6 (called “C-max”) comparing fed MCT to fed LTT oil ingestion
• Improves uptake in the blood with a factor 15 (called “C-max”) comparing fasted MCT to fasted LTT oil ingestion
• Improves uptake in the blood with a factor 34 when comparing fasted MCT-oil to fed LTT-oil ingestion
• Provides a lower inter-individual variation​ as LTT-oil is taken up more uniformly between individuals

Challenge #2: Onset of action
Onset of action is the duration of time it takes to reach maximum concentration of the drug in the blood after administration to the individual. Reaching the maximum (called “T-max”) as fast as possible is important to help patients manage their treatment. For medical cannabis oil products, T-max is typically reached within hours depending on whether patients are fed or fasting. Predictability of onset time is critical to planning the dosing, and therefore the T-max should be identical regardless of the patient’s food intake.

What the study concludes

• Fasted individuals with LTT-oil dosing reach maximum concentration faster (from 3,8 hours to 1,0 hour)
• Fed individuals with LTT-oil dosing reach maximum concentration faster (from 1,9 hours to 1,0 hour)
• Regardless of fed or fasted state, maximum concentration was reached in the same time with the LTT oil 

“In our opinion, the new LTT-oil is truly groundbreaking for the entire industry of medical cannabis and for the patients globally” says Thomas Skovlund Schnegelsberg, CEO of Stenocare and summarizes: “In short, our new oil formulation meets the key challenges in the industry of medical cannabis: 1) It increases the uptake of cannabinoid by a double digit figures, 2) It delivers a uniform uptake in the blood across individuals, 3) the maximum concentration of the drug is reached in half the time, and, finally, 4) it can be delivered in the body with a higher uniformity regardless of food consumption”.

STENOCARE TO TAKE MAXIMUM ADVANTAGE

Stenocare has worldwide exclusivity to leverage the patented LTT-oil for cannabis products.  This translates into a major opportunity to take the global medical cannabis market to the next level. Other vendors are - and will be - in the race for development and introduction of next generation medical cannabis products. Therefore, time-to-market is of essence. With the results from the study, the Company now plans to accelerate the work with its partners to further develop the new product formulations and commercial products using the LTT-oil.

PLAN AND PATHWAY

The ambition is to introduce the first product within the next 18-36 months – pending regulatory approval from the health authorities. There are several important steps towards a commercial product, that include stability testing of the new product formulations and standardization according to regulatory requirements that apply in the individual target markets.

SUCCESS THROUGH PARTNERING

Stenocare expects to both sell LTT-oil products under its own brand in its own markets and may also license the technology to other cannabis brands and vendors with strong distribution power in other markets. At this time, Stenocare is unable to predict or provide guidance on the expected commercial value relating to the LTT-oil.

“We have had early conversations with our partners regarding the benefits with the LTT-oil. With the results from the study, we can be more precise in planning and scoping the opportunity. Even though bioavailability has been a key challenge for a long time in the medical cannabis industry, it is our experience that real data from a pharmacokinetic study regarding the topic has not been available until now. This puts Stenocare in a very strong position to be a first-mover in the development and introduction of next generation of medical cannabis oil products”, comments Thomas Skovlund Schnegelsberg, CEO of Stenocare.

IMPORTANT PS: DAY TO DAY BUSINESS UNCHANGED
All of the above will take place as an activity of upgraded strategic importance. In parallel, Stenocare will continue its day-to-day development of its existing core business, which is to turn its expanding portfolio of licensed products, existing as well as new markets into rapid growth in revenues, as previously communicated.