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
Source: Company Press Release.