Results from German multicentre study strengthen and broaden ColdZyme’s product claims

Published: 28-Jan-2019

Enzymatica AB is a Swedish life science company that develops and sells medical devices for infection-related diseases

At the recent Icelandic Medical Association conference in Reykjavik, Enzymatica presented the final results from a German, multicentre study to assess ColdZyme Mouth Spray during the 2018 cold season.

The convincing results strengthen and broaden ColdZyme’s product claims. The location was chosen because the enzyme used in ColdZyme was discovered and patented in Iceland, where it is now also extracted and produced.

The statistically significant results from the study strengthen ColdZyme’s intended use of reducing the duration of colds, while also broadening its clinical benefit by showing that ColdZyme significantly reduces total symptoms.

More specifically, ColdZyme was shown to alleviate sore throat, nasal congestion and headache, while improving quality of life and reducing the need for concurrent use of symptom-relieving medication for colds.

The single (investigator)-blind, prospective, randomised multicentre study was done at six centres in Germany during the 2018 cold season.

The study included 400 participants who were randomly asked either to initiate treatment with ColdZyme at the first cold symptoms, or not to start any treatment. A total of 267 people with confirmed colds were evaluated in the study.

“The extremely convincing study results enable us to show the specific clinical benefit of using ColdZyme. In addition, the results will serve as the basis for the design of future studies to further strengthen documentation for ColdZyme,” says Fredrik Lindberg, CEO of Enzymatica.

The German multicentre study was a methodological parallel group study designed to investigate the ability of the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21 Quality of life scale), Jackson's cold scale and two different scales for sore throat, to detect positive effects from ColdZyme compared with a group that was not treated with ColdZyme.

In addition, safety data and simultaneous use of symptom-relieving drugs were recorded.

All four symptom scales showed statistically significantly better effects when using ColdZyme compared with no treatment.

The functional parameters of the WURSS-21 scale were the most sensitive for detecting significant effects with ColdZyme use.

Moreover, use of symptom-relieving cold medications was significantly lower among those who used ColdZyme. No difference in frequency of side-effects was seen between the two patient groups.

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