Enzymatica has developed ColdZyme, a mouth spray that protects against colds and flu and treats and relieves symptoms. ColdZyme creates a protective barrier in the throat that prevents airborne viruses from attaching to cells and causing infection. The product is classified as a medical device and has received CE certification according to the MDR.
Investigation of cold products
This spring I got State preparation for medical and social evaluation (SBU) commissioned by the government to evaluate whether medical devices, vitamins and minerals can prevent, alleviate, shorten or cure a cold.
There are currently a number of consumer products for colds, including medical devices. SBU focused primarily on oral or nasal sprays and identified several studies with oral sprays containing trypsin (ColdZyme) and carrageenan (Viruseptin), substances that prevent the virus from binding to cells.
The results showed risk of bias
At the end of August, the SBU presented the results of the investigation, which overall show that there is no clear scientific support that vitamins, minerals or medical devices can prevent, alleviate, shorten or cure a cold.
According to the SBU's investigation, it is difficult to determine whether medical devices are effective because the studies conducted are considered to have a high risk of bias, which can lead to both overestimation and underestimation of the treatment effect. This can therefore lead to distorted results.
The investigation showed that several of the studies were sponsored by the companies behind the products, and that several of the authors of the studies' publications were employed by the companies or had other connections to them. According to SBU, it is desirable to minimize connections to the manufacturer in order to obtain the most reliable results possible. In addition, it is important that all studies are published, and that the study protocol and analysis plans are registered before the start of the study, which was not the case for some of the studies.
Enzymatica's CEO comments on the evaluation
Enzymatica CEO Claus Egstrand thinks it is good that the investigation has been carried out, but questions the method in the investigation. He also highlights that it is routine for companies to pay for the initial scientific studies themselves if they want their medical device or drug to be reviewed and approved by notified bodies and authorities.
- Because SBU followed its standardized method of only reviewing already published studies, data from the Kent study was not included. This is unfortunate because the Kent study is both independent of the company and shows concrete and measurable differences between ColdZyme and placebo, Claus writes in Enzymatica's Q3 report.
The final results from the study at University of Kent shows that ColdZyme shortens the duration of the illness by approximately five days. The study will be presented in its entirety in a scientific journal in the coming months.
BioStock contacted CEO Claus Egstrand to find out more about his thoughts on the investigation and the company's
What are your thoughts on SBU's evaluation?
– We think it is good that the subject is being investigated. There are many misconceptions about the common cold and myths about which treatments help. However, we think that SBU is getting lost both in the scope of the assignment and in parts of the chosen methodology. SBU has chosen to exclude all medicines for colds/cold symptoms and has only focused on the scientific effect of a few vitamins, minerals and medical technology. Their main objection to the scientific studies on ColdZyme is that they were partly conducted by people who were associated with Enzymatica. Therefore, according to SBU, there is a risk of bias in the analysis.
What do you have to say about their view that many of the studies have been sponsored by the company?
– It is very common for companies that plan to put a product on the market, regardless of whether it is medical technology or pharmaceuticals, to also finance studies prior to certification and launch. SBU seems to miss this completely. They have also only reviewed studies that have already been published. This is despite the fact that we contacted SBU in the spring that the data from the Kent study showed solid and independent scientific results. Since then, additional results have been released from the same study, but SBU chose not to present them.
- The same studies that the SBU condemns have been used as the basis for the certification and subsequent CE marking that ColdZyme received this spring according to the EU's MDR regulations. So for us, this is a bit like rolling out of the Swedish Vehicle Inspection with a car completely without any complaints and then another authority stands outside and says that it is not possible to determine whether the car works.
How does Enzymatica work to ensure objectivity and minimize the risk of bias in research on ColdZyme and its effects?
- I can give two examples. We did not know about the first study by Professor Doris Wilflingseder at the Medical University of Innsbruck until it was completed. She had simply bought ColdZyme at her local pharmacy. She is a researcher with very high integrity and even in the continued studies we have kept a distance in terms of the design, content, methodology and analysis of the studies. We have contributed products but have not otherwise been involved.
- The recently completed Kent study follows the same logic. We have not been involved in the design, implementation or analysis of the data. We have supported the study with, among other things, product samples and financial contributions to the university's advertising to find participants. But we have no part in the scientific study itself. Professor Glen Davison wants to conduct his study on a strictly scientific basis.
Do you think Enzymatica will be affected by the SBU's evaluation and if so, in what way?
- We have received a number of questions from consumers and shareholders on this topic, but we see the conclusions of the study as completely neutral for us. There is no negative impact on sales whatsoever. Most articles written about the SBU survey have been balanced, although we see that some experts draw categorical conclusions that I believe they will need to re-evaluate when they seriously study the results of the Kent study.
What is your personal opinion on how the company's shareholders should reason regarding the SBU's investigation?
- We have many very committed and well-read owners and in general I want to be careful about telling them what to think. But my personal opinion about the SBU study is that it is a shame that SBU, by following the map, instead of reality, missed to include that there is a Swedish product that can relieve and treat colds in a unique way.
