The clinical trial data show that the CANNASEN®CBD Psoriasis Gel (NGP-01)  shows no adverse effects and is well tolerated and safe. No negative issues have been reported by the participants and all the vital signs were found normal at all the visits.

Increased Quality of Life for the Participants
The median Quality of life questionnaire (EQ-5D by Euro QOL) score was significantly reduced in the treatment group, meaning that the Quality of life for the participants was increased for the participants using the CANNSEN®CBD Psoriasis Gel. This is correspondent to the results of PASI-, NRS-, sPGA-Induration-, sPGA-Erythema-, sPGA-Scaling score and the SGA value, which all scores/values indicating pain or discomfort were significantly reduced.

[image]Figure 1: Increased Quality of Life EQ-5D QOL Score on CANNASEN®CBD Psoriasis Gel(as the pain reduces

CEO Lone Henriksen comments:
"Firm scientific confirmation of our results is always welcome. We are excited that our hard work is now taking the important steps into the real world. First and foremost, as a promise to help psoriasis patients live better lives. The solid proof of intended effect and full product safety of CANNASEN®CBD Psoriasis Gel is the foundation for improving quality of life for many people in the years to come.

Proof of Concept
With the clinical results from this clinical trial, CS MEDICA now holds "proof of concept" on the Psoriasis Gel, which has been awaited by several potential distribution partners and NGO's. Information about these clinical trials is now being distributed to potential partners, to secure the finalizing distributor agreements and the following market scale-up. 

The Company now holds "proof of concept" for the following CANNASEN®CBD products via clinical trials:

• CANNASEN®CBD

Psoriasis
Gel                

• CANNASEN®CBD

• CANNASEN®CBD

• CANNASEN®CBD Anti

Study design
The final objective analysis is based on 60 cases of mild-to-moderate psoriasis, as specified in the study protocol.

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.

The study has been performed as a phase 3, randomized, double-blind, multicenter, placebo controlled, parallel-group, 2-arm trial designed to evaluate the safety, tolerability, and efficacy of NGP-01 gel when administered for up to 90 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of mild-to-moderate plaque psoriasis. All enrolled subjects have received either NGP-01 (CANNASEN®CBD Psoriasis 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 90 days. Subjects visited for study-related assessments on days 1st, 15th, 30th, 45th and 60[th], 75[th] and the 90[th] day.

[image]Figure 2: Trial design

The full study with the results of each primary and secondary efficacy endpoint will be published, in a scientific paper developed with the help of The University of Naples Federico II (http://www.international.unina.it/)[1]. The scientific paper will be published at a later stage, expectedly within this calendar year.

[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 29-08-2022 08:45 CET.