Regulatory press release

Enzymatica AB: Interim results from independent clinical study of ColdZyme® show duration of illness lowered by approximately 5 days

University of Kent has earlier this afternoon published interim results from the ongoing double-blind, placebo-controlled, randomized on the effects of ColdZyme and the product's effect on treating the symptoms and duration of Upper Respiratory Tract Infections (URTI). Interim results have showed that Enzymatica's ColdZyme® oral spray reduces the amount of rhinovirus and reduces the number of sick days by approximately five days, with number of sick days being the primary endpoint of the study.

The study is an independent, investigator-initiated in vivo study led by Glen Davison, professor of sports and exercise science and researcher in exercise immunology at the University of Kent, in England.

Glen Davison researches the effects of training and exercise on the immune system and the body's resistance to infections. The main focus is evaluating products and measures that can help prevent upper respiratory tract infections, such as the common cold. Glen Davison and his research team have been studying the effects of ColdZyme® since 2017 and published the first study four years ago.

"This study is now complete, and we are in the process of completing all the final analysis, etc. We hope to publish the full results in peer-reviewed scientific results later this year. The findings are really exciting, and the reduction in the duration of illness (reduced by about five days) can be of real practical benefit to athletes and the wider population." says Professor Glen Davison.

"Initial observations announced in September last year have shown that symptoms are milder and that illness duration is shorter. The latest data, from more than a total of 100 study participants, continue to validate the initial findings, and the swap analysis shows lower viral load (for Rhinovirus, the most common URT causing pathogen). We are confidently awaiting the completion of Professor Glen Davison's study and the final results." says Claus Egstrand, CEO of Enzymatica.

The study is investigator-initiated, prospective, double-blind, placebo-controlled, and randomized. The study includes roughly 160 athletes in endurance sports, divided into two groups, where one received ColdZyme and the other a placebo. The participants have kept a training diary and filled in a daily questionnaire about symptoms in the upper respiratory tract. When participants experienced symptoms, they took throat samples and began using the mouth spray as instructed.

See official press release from the University of Kent/ Link to the interim results (https://www.kent.ac.uk/news/health-social-care-and-wellbeing/35141/athletes-and-public-to-benefit-from-new-research-on-reduction-of-upper-respiratory-tract-illness)

Facts ColdZyme®

ColdZyme® directly forms a physical barrier in the mouth and throat that coats, moisturizes and protects the oral cavity and throat, trapping viruses and inactivating and inhibiting the ability of trapped viruses to infect cells and reproduce. The over-the-counter mouth spray has been certified according to the EU regulation MDR (class III) by Eurofins, an approved European control body for medical devices. The certification entails stricter requirements for the evidence of clinical validity, safe design and market surveillance. ColdZyme® products are now MDR certified with the following expanded intended uses:

Treat and relieve cold and flu-like symptoms.

and with the following extended product claims:

Protects against viruses that cause cold and flu-like infections in the upper respiratory tract.
Shortens the duration of cold and flu-like infections of the upper respiratory tract if used at an early stage of the infection.
Relieves cold and flu-like symptoms, including sore throats.