Enzymatica has now finalized the enrolment to its prospective double-blind, placebo-controlled multicentre study to evaluate the effects of ColdZyme® on the common cold. In total about 700 patients have been enrolled at ten study centres in Germany. Of the enrolled patients more than 400 have caught a cold, which is according to plan for the study.
The overall goal of the study is to evaluate the efficacy of ColdZyme on the common cold. The primary objective is to assess the impact 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. The participants will be randomised to treatment with ColdZyme or placebo. Neither investigators nor patients will know which treatment the patients receive.
“To secure that we reach 400 patients with reported common cold during the spring we decided to increase the enrolment from 600 to about 700 patients. The enrolment has proceeded above expectations and we have now obtained more than 400 patients who have caught a common cold,” says Fredrik Lindberg, CEO of Enzymatica.
The study is a follow-up of a single-blind, prospective, controlled multicentre study of ColdZyme that Enzymatica conducted at six centres in Germany 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 with a control group that did not use ColdZyme. A total of 267 subjects with confirmed colds were evaluated in the study.
The ongoing placebo study in Germany is expected to be completed during the second half of 2019. The results will be important to establish ColdZyme as an evidence-based treatment for the common cold.
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