30 January 2019
First patients included in large placebo-controlled multicentre study on ColdZyme
Enzymatica has initiated a prospective double-blind, placebo-controlled multicentre study to evaluate the effects of ColdZyme® Mouth Spray on the common cold. The study will include 600 patients and is conducted at 10 study centres in Germany. The first patients have now been enrolled in the study, which is expected to be completed during the second half of 2019.
The goal of the study is to evaluate clinical effects of ColdZyme on the common cold. The primary objective is to assess the effect of ColdZyme on quality of life during a common cold period, with the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life (QoL) subscore.
A total of 600 participants will be enrolled in the study at 10 study centres in Germany. The participants will be randomised to treatment with ColdZyme or placebo.
The study is a follow-up of a single-blind, prospective, controlled multicentre study of ColdZyme that Enzymatica conducted during the 2018 cold season. That study showed a significant reduction of both the duration of the cold and the intensity of symptoms with use of ColdZyme, as well as improved quality of life and reduced use of symptom-relieving drugs, compared to a control group that did not use ColdZyme. A total of 267 people with confirmed colds were evaluated in the study.
"In the new placebo-controlled study we want to confirm the very strong results of the previous multicentre study, establish ColdZyme as an evidence-based treatment for the common cold and thereby accelerate our international expansion, which is already underway," says Fredrik Lindberg, CEO of Enzymatica.
Title: Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
More information is available at https://clinicaltrials.gov/ct2/show/NCT03794804.
ClinicalTrials.gov Identifier: NCT03794804
For more information please contact:
Fredrik Lindberg, CEO, Enzymatica AB
Tel: +46 (0)708-86 53 70 | Email: firstname.lastname@example.org
Carl-Johan Wachtmeister, Head of Corporate Communications, Enzymatica AB
Tel: +46 (0)701-88 50 21 | Email: email@example.com
About Enzymatica AB
Enzymatica AB is a Swedish life science company that develops and sells medical devices for infection-related diseases. The products are based on a barrier technology that includes marine enzymes. The company's first product is ColdZyme® Mouth Spray, which can prevent colds and reduce the duration of disease. The product has been launched in about ten markets. The strategy is to continue to grow by strengthening the Company's position in existing markets and expanding into new geographic markets through established partners. The company has its headquarters in Lund and is listed on Nasdaq First North. For more information, visit: www.enzymatica.com.
Enzymatica's Certified Adviser is Erik Penser Bank.
Tel: +46 (0)8-463 83 00