The COLDPREV study: ColdZyme Mouth Spray reduces both the viral load and the number of sick days with common cold in infected individuals, compared with placebo

Regulatory information

Enzymatica today reports positive results from a clinical pilot study on 46 individuals performed at the Ear, Nose and Throat Clinic at Skåne University Hospital in Lund, Sweden. In individuals who were infected with the common cold virus, ColdZyme Mouth Spray reduced both the viral load and the number of sick days with a cold compared with placebo.

“These are very interesting and promising results. The COLDPREV study shows statistically significant results with ColdZyme Mouth Spray in terms of reduction of the viral load in the throat and number of sick days with common cold in infected subjects,” says Enzymatica's Head of R&D, Mats Clarsund.

”COLDPREV” – which was performed during the spring at the Ear, Nose and Throat Clinic at Skåne University Hospital – is a randomised, double-blind, placebo-controlled clinical pilot study for the CE-marked medical device ColdZyme® Mouth Spray. In this study 46 subjects, both men and women (aged 20-46), were inoculated (infected) with the common cold virus (rhinovirus) via the nose. Despite the study being a pilot study, aimed at providing a basis for larger studies, a statistically significant difference was found between ColdZyme and placebo with regard to reduction of the viral load in the throat (-99%) and reduction in the number of days with a cold (-54%).

“Although the study with ColdZyme was not conclusive in all respects, the results are interesting,” says the Physician, consultant; senior specialist Cecilia Ahlström Emanuelsson, who was the primary investigator for the study.

ColdZyme® Mouth Spray is a CE-marked medical device intended to be used to reduce the risk of developing a cold or to shorten the period of illness when early symptoms of illness appear, by creating a protective barrier in the oral cavity and throat. This product was registered at the Swedish Medical Products Agency as a class I medical device in August 2012. Sales of ColdZyme® Mouth Spray began at pharmacies throughout Sweden in February 2013. 

For further information about the COLDPREV study, contact:
Mats Clarsund, Head of Research and Development at Enzymatica AB (publ), +46 (0) 733-46 34 29
mats.clarsund@enzymatica.se

For further information about Enzymatica, contact:
Michael Edelborg Christensen, CEO of Enzymatica AB (publ), +46 (0) 768-14 41 66,
michael.christensen@enzymatica.se


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