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Publicerat: 2022-07-12 20:53:39

CS MEDICA A/S: CS MEDICA announces positive clinical trial results from the final report on NGA-01 gel & NSA-01 capsule (CANNASEN®CBD Arthritis Gel & CANNASEN®CBD ARTH Supplement) in combination against placebo

CS MEDICA ("CS MEDICA" or the "Company") announces today that, after conducting the final efficacy analysis in their clinical trial, their CANNASEN®CBD Arthritis Gel & CANNASEN®CBD ARTH Supplement (NGA-01 gel and NSA-01 capsule), met all the trial’s primary and secondary efficacy, tolerability & safety endpoints. The final analysis was based on 60 cases of osteoarthritis. The trial data showed that both NGA-01 and NSA-01 were well tolerated, no adverse event was reported, and no significant changes were observed in the urinalysis. The results strengthen our product offering and improve our competitive advantage in the Medical CBD product market.

Today, CS MEDICA announces the final trial data from their clinical trial on NGA-01 and NSA-01. The primary objective was to evaluate the efficacy of NGA-01 gel and NSA-01 capsule in relief in joint pain, inflammation and mobility for patients with arthritis. The secondary objective was to study the cooling effect and bone strengthening activity of NGA-01 gel and NSA-01 capsule, to evaluate the safety of NGA-01 gel and NSA-01 capsule when administered to adult subjects with Osteoarthritis with joint pain, to evaluate the tolerability of NGA-01 gel and NSA-01 capsule when administered to adult subjects with Osteoarthritis with joint pain. The final objective analysis is based on 60 cases of Osteoarthritis, as specified in the study protocol.  

Lone Henriksen comments
“This clinical study results, mark another important step for CS MEDICA and continues our strong track record for delivering impactful products.  It gives us a unique position in the market as first mover with proven effective and safe Medical CBD products. 
It paves the way for further R&D of products within this category and gives us a solid foundation to build our commercial track record. These results combined with the patents pending and trademark foresee a high value & revenue in the years to come.

We are proud to share these results as the trial shows that the CANNASEN®CBD Arthritis Gel & CANNASEN®CBD ARTH Supplement in combination are proving to be both safe and efficient for patients and most important our CANNASEN®CBD Arthritis Gel & CANNASEN®CBD ARTH Supplement improves the overall quality of life for patients with Osteoarthritis.”

The data of the trial shows that the CANNASEN®CBD Arthritis Gel & CANNASEN®CBD ARTH Supplement (NGA-01 and NSA-01 capsule) was well tolerated, and no adverse event was reported during the study & no significant changes were observed in the urinalysis. All the vital signs were found normal at baseline and the end visit.

The conclusion of the study
The WOMAC Index and VAS score has significantly reduced in the Test arm
(active product test) with a combination of CANNASEN®CBD Arthritis Gel & CANNASEN®CBD ARTH Supplement (NGA-01 gel and NSA- 01 capsule). All the major attributes like pain, stiffness, tenderness, crepitus, and pain during flexion have shown improvement during the treatment. Both Subject’s and Physician’s Global Assessments (SGA) have shown reduction in the disease intensity on one hand, and EQ-5D has shown betterment in the overall life quality of the subjects. There was reduction observed in the Hs-CRP & ESR values and the change were significant for ESR values. The Treatment was found well tolerable, and no AE (Adverse Events) were reported during the study. The Pain indices, assessments, and life quality questionnaires together confirms that the combination of CANNASEN®CBD Arthritis Gel & CANNASEN®CBD ARTH Supplement (NGA-01 gel and NSA-01 capsule) is effective in the treatment of Osteoarthritis with joint pain, along with improving the overall quality of life.

WOMAC Index; The Western Ontario and McMaster Universities Arthritis Index (WOMAC[1]) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:

  • Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
  • Stiffness (2 items): after first waking and later in the day
  • Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties

Change in patient reported joint pain and function scores. WOMAC score has 3 subdivisions which include knee pain, stiffness, and physical function. The score ranges from 0-96, with lower scores representing better knee pain, stiffness, and function.

WOMAC- Index for Osteoarthritis, Functional ability were assessed by; 1. Walking - time required to cover 30 meters in seconds. 2. 10 sit -ups time required in seconds and 3. Time taken to climb 10 steps.

VAS score; One of the important scores/results is the VAS score, which is the Visual Analogue scale (VAS) - a psychometric response scale that have been used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

The EQ-VAS[2] records the subject’s perceptions of their own current overall health and can be used to monitor changes over time. The self-assessment questionnaire is self-reported description of the subject’s current health in 5 dimensions (EQ-5D[3]), i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.


Figure 1: VAS with other Visual Scales

Subject Global Assessment of disease severity (SGA), Subjects grades the overall severity of their symptoms according to the following 5-point scale:

0= Clear; no Arthritis symptoms at all.
1= Very mild; very slight Arthritis symptoms that do not interfere with daily life.
2= Mild; slight Arthritis symptoms that interfere with daily life only occasionally.
3= Moderate; definite Arthritis symptoms that interfere with daily life frequently.
4= Severe; intense Arthritis symptoms that interfere or restrict daily life very frequently.

The subject will perform a disease assessment using subject’s global assessment (SGA).

Hs-CRP & ESR values; Since pain and inflammation are often intertwined, these two commonly ordered blood tests can be helpful indicators that pain and inflammation are present. The erythrocyte sedimentation rate (ESR or sed rate) and C-reactive protein (CRP) are among the oldest laboratory tests still in use. Both bloods tests are used to detect inflammation in the body. Inflammation can present as either acute (i.e., from injury or infection) or chronic. Multiple cells are involved in the release of inflammatory mediators, which combine to generate pain in joints, muscle, discs, ligaments, tendons, fascia, etc. Since pain and inflammation are often intertwined, the two tests can be indicators that pain and inflammation are present, as well as be markers of treatment effectiveness.

Results
The full study with the results of each primary and secondary efficacy endpoints will be published in a scientific paper on a later stage. As we are developing a scientific paper, we cannot disclose the efficacy endpoints at this stage.

 

Study design
The study design was a double blind, randomized, parallel group study to evaluate efficacy and safety of combination of NGA-01 gel and NSA-01 capsule in the treatment of Osteoarthritis with joint pain (NGA-01 gel and NSA-01 capsule) when administered for up to 60 days at 60 adults between the ages of 30 to 80 years, who have a clinical diagnosis of Osteoarthritis with joint pain at any of the joints; Knee, Hip, Ankle, Elbow and Shoulder.

This study was performed in accordance with ICH E6 R2, Schedule-Y (2017) and Ethical Principles as per the Declaration of Helsinki (2013) including archiving of all the essential documents.

This study was conducted in compliance with the final protocol, the applicable Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), the relevant sections of Good Laboratory Practice (GLP), local laws and regulations and the provisions of Declaration of Helsinki.

All enrolled subjects have received either NGA-01 and NSA-01 capsule (CANNASEN®CBD Arthritis Gel & CANNASEN®CBD ARTH Supplement) or placebo gel & Capsule (randomized in a 1:1 ratio) with the first dose applied at the Day 1 Study Visit. Subjects were instructed to apply the study medication twice daily for 60 days. Subject’s visited for study-related assessments on days 1st, 15th, 30th, 45th and 60th day.

This study was verified and reviewed independently according with the final protocol, the applicable Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), the relevant sections of Good Laboratory Practice (GLP), local laws and regulations and the provisions of Declaration of Helsinki.

[1] WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities. WOMAC is available in over 65 languages and has been linguistically validated. Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from baseline [Time Frame: Any time-point from Baseline to Day 60]
[2] The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
[3]
EQ-5D is one of the most reliable QOL questionnaire for Arthritis and other pain related studies.  It consists of a questionnaire and a visual analog scale (EQ- VAS).


 


This disclosure contains information that CS MEDICA A/S is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 12-07-2022 20:53 CET.

For more information about CS MEDICA, please contact:
Lone Henriksen, CEO
Phone: + (45) 71 20 30 47
Email: lh@galaxapharma.com
Website: https://www.cs-medica.com/

CS MEDICA A/S is a Danish medico cannabis company founded in 2011. CS MEDICA is committed to developing, manufacturing, and commercializing over-the-counter (OTC) medical device products containing cannabinoids. The Company runs its business through the two fully-owned subsidiaries, Galaxa Pharma A/S (distributor and representative of foreign manufacturers in the Nordic, registered medical device product distributor) and CanNordic A/S (Medical device developer and seller (BtB), registered medical device product manufacturer). CS MEDICA distributes products across the European borders and is headquartered in Copenhagen, Denmark.

The company is listed on Spotlight Stock Market in Stockholm (symbol: "CSMED"). For more information about CS MEDICA cs-medica.com.

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