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2021-09-10

CS MEDICA A/S: CS MEDICA's clinical trial Phase III results from the intermediate report on NGA-01 (CANNASEN®CBD Arthritis Gel) against placebo

Today, September 10[th], 2021, CS MEDICA A/S's ("CS MEDICA" or the "Company") can announce that the CANNASEN®CBD Arthritis Gel (NGA-01) has, after conducting the final efficacy analysis in the ongoing Phase III trial, met all the trial's primary efficacy endpoints. Analysis of the data indicates that CANNASEN®CBD Arthritis Gel (NGA-01) has an efficacy rate of 89 percent in reduction of pain in joints of participants with Osteoarthritis with joint pain in any of the joints; knee, hip, ankle, elbow, and shoulder. The data of the trial shows that the CANNASEN®CBD Arthritis Gel (NGA-01) was well tolerated, and no adverse events/effects have been seen nor reported by the participants.

Lone Henriksen comments
"The intermediate study results mark an important step for CS MEDICA and continues or 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."

The clinical trial Phase III results
The CANNASEN®CBD Arthritis Gel (NGA-01) has, after conducting the final efficacy analysis in the ongoing Phase III trial, met all the trial's primary efficacy endpoints. Analysis of the data indicates that CANNASEN®CBD Arthritis Gel (NGA-01) has an efficacy rate of 89 percent in reduction of pain in joints of participants with Osteoarthritis with joint pain in any of the joints; knee, hip, ankle, elbow, and shoulder. The first primary objective analysis is based on 28 cases of Osteoarthritis, as specified in the study protocol.  

The data of the trial shows that the CANNASEN®CBD Arthritis Gel (NGA-01) was well tolerated, and no adverse events/effects have been seen nor reported by the participants.

Summary of the results
The primary objective of the clinical trial Phase III is 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 primary efficacy analysis of pain relief demonstrates NGA-01(CANNASEN®CBD Arthritis Gel) to be 89 percent effective in the reduction of pain in joints versus placebo, and 37,5 percent effective in the reduction of pain in joints.

  • The primary efficacy analysis of anti-inflammation demonstrates NGA-01(CANNASEN®CBD Arthritis Gel) to be 56 percent effective in the reduction of swelling in joints versus placebo, and 27 percent effective in the reduction of swelling in joints.

  • The primary efficacy analysis of increased mobility demonstrates NGA-01(CANNASEN®CBD Arthritis Gel) to be 44 percent effective in the reduction of stiffness in joints, 58 percent effective in the reduction of crepitus in joints versus placebo, 34 percent effective in the reduction of stiffness in joints and 37 percent effective in the reduction of crepitus in joints.

  • The primary efficacy analysis of pain relief demonstrates NGA-01(CANNASEN®CBD Arthritis Gel) to be 63 percent effective in the reduction of VAS score (from average 4,8 to average 1,8) versus placebo, and 30 percent effective in the reduction of VAS score(from average 4,0 to average 2,8).

  • No adverse effect seen so far.

The Phase III clinical trial of NGA-01 (CANNASEN®CBD Arthritis Gel) has enrolled 60 Osteoarthritis patients, the enrollment is over, and we should have the result of the whole Phase III clinical trial within the next 4 months. The data given in this press release covers 28 completed cases.

The study design is a multicenter, randomized, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of NGA-01 (CANNASEN®CBD Arthritis Gel) when administered for up to 60 days to 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.

All enrolled subjects will receive 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 will be instructed on how to apply the study medication twice daily for 60 days. Subjects will return to the clinic for study-related assessments on Study Days 1, 15, 30, 45 and a final visit on the 60[th] day.

 

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/

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