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CS MEDICA ("CS MEDICA" or the "Company") announces today that the final efficacy analysis in their clinical trial of CANNASEN®CBD Arthritis Gel (NGA-01) met all the trial's primary efficacy endpoints. Analysis of the data indicates that CANNASEN®CBD Arthritis Gel (NGA-01) has efficacy in reducing pain in joints, swelling, stiffness, and pain during flexion of joints of participants with osteoarthritis with joint pain in the joints; knee, hip, ankle, elbow and shoulder. The final objective analysis is based on 60 cases of osteoarthritis, as specified in the study protocol.
The trial data show that the CANNASEN®CBD Arthritis Gel (NGA-01) was well tolerated, and no adverse events/effects have been seen nor reported by the participants.
The primary objective of the clinical trial was to evaluate the efficacy of NGA-01 (CANNASEN®CBD Arthritis Gel) in the relief of joint pain, inflammation and mobility for patients with Arthritis.
The conclusion of the study is as follows; the WOMAC Index and VAS score has significantly reduced in the NGA-01 arm (CANNASEN®CBD Arthritis Gel). All the major attributes like pain, swelling, stiffness, tenderness, crepitus, and pain during flexion have shown improvement during the treatment. Both Subject's and Physician's Global Assessments have shown a reduction in the disease intensity on one hand, and EQ-5D has shown betterment in the overall life quality of the subjects. The Treatment was found well tolerable, and no adverse events were reported during the study. The Pain indices, assessments, and life quality questionnaires together confirm that NGA-01 (CANNASEN®CBD Arthritis Gel) is effective in the treatment of osteoarthritis with joint pain, along with improving the overall quality of life.
The full study with the results of each primary efficacy endpoint will be published, in a scientific paper developed with the help from The University of Naples Federico II (http://www.international.unina.it/)[i]. The scientific paper will be published at a later stage, expectedly within this calendar year.
CEO Lone Henriksen comments:
"The clinical study results mark an important step for CS MEDICA as we continue our strong track record for delivering impactful products. We are proud to share these results as the trial shows that the CANNASEN®CBD Arthritis Gel is proving to be both safe and efficient for patients and most important our CANNASEN®CBD Arthritis Gel improves the overall quality of life for patients with osteoarthritis."
The study design was a multicentre, randomized, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of NGA-01 (CANNASEN®CBD Arthritis Gel). The patients were administered for up to 60 days and consisted of adults between the ages of 30 to 80 years who have a clinical diagnosis of osteoarthritis with joint pain at any of the following joints: knee, hip, ankle, elbow and shoulder.
All enrolled subjects have received either NGA-01 (CANNASEN®CBD Arthritis Gel) or placebo (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. Subjects visited for study-related assessments on days 1st, 15th, 30th, 45th and 60th day.
[1] The School of Medicine and Surgery, Italy - Department of Pharmacy - with more than 10 years' experience in cannabinoids, endocannabinoids and the endocannabinoid system.
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 23-06-2022 08:00 CET.