STENOCARE announces positive outcome of feasibility study

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

STENOCARE A/S (“STENOCARE”) and Solural Pharma (“Solural”) hereby announce that they have reached milestone 1 in the research and development of a new medical cannabis oil formulation, that has the potential to improve the uptake of cannabinoids to be consistent in patients. The milestone is reached in a feasibility study and shows that the Solural Pharma’s Lymphatic Targeting Technology is compatible with full spectrum medical cannabis materials.

In December 2019, STENOCARE and Solural announced their partnership to jointly develop and test new medical cannabis products that address important challenges with medical cannabis products, such as:

• Optimizing dosage delivery to patients: When patients are ingesting (eating or swallowing) medical cannabis, their uptake and metabolism will reduce the cannabinoid dose that is absorbed by the body. This mean that a highly variable and very little part the cannabinoids are actively delivered inside the patient for a therapeutic effect. Up to 85% is “lost”, which translates into a very low bioavailability for some patients.

• Eliminating food effect during dosage delivery: Prescribing the right dosage volume for patients at a given point in time is depending upon whether the drug is taken before or after intake of food. The body’s absorption will be different in these two scenarios. By eliminating the food effect, the patients can take the dose at any time of the day, with or without food, and still obtain the same consistency and effectiveness of the medicinal cannabis.

Conclusion for step 1: The important objective was to test and verify that the Lymphatic Targeting Technology is compatible with medical cannabis material. Solural has in their Lab tested their technology with different carrier oils and full spectrum cannabis flower batches from the STENOCARE facility. The conclusion is that the technology is fully compatible with medical cannabis. This indicate that there is a very high likelihood to address the mentioned challenges, and STENOCARE could leverage this in future products that are exclusive and patented for STENOCARE all over the world.

Ready for step 2 study: The next step in the development process is to analyze and validate the effect of the new oil formulation to confirm the beneficial effects in vivo (i.e in living organisms). An external research company will be used to complete a pharmacokinetic study that should measure bioavailability in Fed and Fasted state. The study will be designed to compare the special formulation with a commercially available medical cannabis oil product. This will enable a benchmark for the potential and effectiveness of the new product formulation. The timeline for completing step 2 is during Q3 2022.

Longer-term perspectives: STENOCARE has a pharma mindset to cultivation and production of medical cannabis products. An important element is to develop unique product formulations for patients’ treatment, that optimize the effectiveness of the drug. Provided that Step 2 is also concluded with success, STENOCARE can begin building the application package for new products in Q4 2022. This includes real time stability studies with an external research company, lab analyses of multiple batches and pharmaceutical documentation of each individual compound in the product. Once the application package is complete, then the application is ready for the review and approval process with the medicines agency. The process is projected to take 18-36 months to complete from the time the approval package is ready.

Thomas Skovlund Schnegelsberg, CEO of STENOCARE is commenting:

“It is encouraging that we have now completed the step 1 feasibility study with positive results. This is an indicator that we are on a path to address some of the most important industry challenges for medical cannabis. Ahead awaits further investments in a pharmacokinetic study and analysis that we hope will validate our new oil formulation. Even though this type of product development is a longer-term investment, we are optimistic that this will become a valuable premium product that will increase efficacy for patients. STENOCARE has worldwide exclusivity to leverage the Solural Lymphatic Targeting Technology for cannabis, and therefore this work is an important part of our STENOCARE 2.0 strategy, which is about pursuing the highest standards, with inspiration from best practice in the established pharma industry.”