Preliminary Results of Enzymatica's Placebo-controlled, Randomized Study did not Meet the Primary End-point
STOCKHOLM, Sept. 4, 2019 /PRNewswire/ -- Preliminary results show that Enzymatica's prospective, randomized, double-blinded multicenter study did not meet the primary end-point "Significant improvement of quality of life during treatment with ColdZyme compared to placebo in common cold".
Totally 700 participants were enrolled at ten study centers in Germany. The more than 400 participants who caught a cold were randomized to treatment with either ColdZyme or placebo in a double-blind fashion.
The primary objective was to prove that ColdZyme improved quality of life during a common cold period, compared to placebo, assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life (QoL) domain. Preliminary top line results from the study showed that the primary endpoint according to WURSS-21 QoL domain was not met.
"The preliminary top line result from the recently conducted placebo study deviate from the result in the multicenter study that was conducted last year. We now have to await the full report and analyze in detail why the two studies have discrepancies in outcome, and also look at other study parameters," says Fredrik Lindberg," CEO of Enzymatica.
The placebo study was a follow-up of a single-blind, prospective and controlled multicenter study with ColdZyme that was conducted at six centers in Germany during 2018. That study included 400 participants who were randomly assigned to treatment with ColdZyme at the first signs of a common cold, or to no specific treatment. A total of 267 people with confirmed colds were evaluated and the results showed statistically significant advantages with ColdZyme, such as reduction of the duration, alleviation of symptoms, improved quality of life and a reduction of the need for concurrent use of symptom-relieving medication.
The information in this press release is information that Enzymatica is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 3 pm CET on September 4, 2019.
For more information please contact:
Fredrik Lindberg, CEO Enzymatica AB
Tel: +46 (0)708-86 53 70
Head of Corporate Communications, Enzymatica AB
Tel: +46 (0)701-88 50 21
About Enzymatica AB
Enzymatica AB is a Swedish life science company that develops and sells medical devices for infection-related diseases. The products are based on a barrier technology that includes marine enzymes. The company's first product is ColdZyme®, which can prevent colds and reduce the duration of disease. The product has been launched in about ten markets. The strategy is to continue to grow by strengthening the Company's position in existing markets and expanding into new geographic markets through established partners. The company has its headquarters in Lund and is listed on Nasdaq First North Growth Market. For more information, visit: www.enzymatica.com and www.enzymatica.se/en/section/media/press-releases.
Enzymatica's Certified Adviser is Erik Penser Bank.
Tel: +46 (0)8-463 83 00
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
Upcoming Life Sciences Events
- September 2019
- Dusseldorf: 5th Annual Pre-Filled Syringes & Injectables Summit
- Munich: The Biotech & Pharma Summit: Drug Delivery & Formulation
- Brussels: The Pharma Forecasting Course