Enzymatica AB: Top-line results of new clinical trial

2016-12-21

Enzymatica today announced the results from the clinical study ENZY-002, a trial investigating the performance of ColdZyme® Mouth spray on experimentally induced rhinovirus infection in 88 healthy volunteers. ENZY-002 did not meet its primary endpoint of significantly lowering virus load compared to placebo in this mild experimental model of the common cold. The company remains committed to pursue its plan of international expansion of ColdZyme, and to continue investigations regarding the performance of ColdZyme against real-life, naturally occurring colds.

The ENZY-002 (COLDPREV II) study was a randomized, double-blind placebo-controlled clinical study of ColdZyme Mouth spray for colds. 88 subjects, both men and women, were experimentally inoculated (infected) with the cold virus (rhino virus16). The primary endpoint, reduction of the total viral load in the throat, and the secondary endpoint, reduction of the number of days with common cold symptoms, did not show significant difference between ColdZyme and placebo.

In a previous study, COLDPREV I, where 44 healthy volunteers were inoculated with rhino virus16 and treated with either ColdZyme or placebo, there was a significant reduction in both number of reported sick days and virus load in subjects treated with ColdZyme compared to placebo. One possible explanation why the actual study could not repeat the positive results from the COLDPREV I study, is differences in reported symptom scores between the two studies, with significantly milder symptoms and shorter disease duration being recorded among the healthy volunteers in the actual study.

Fredrik Lindberg, CEO of Enzymatica commented: "While we are disappointed ColdZyme did not meet its endpoints in this experimental model of the common cold, we remain committed to continue investigations regarding the performance of ColdZyme against real-life, naturally occurring colds. The result of COLDPREV I, several user studies and customer surveys give strong support for ColdZyme.

The product, being one of the few treatments that addresses the source of common cold by protecting the throat from virus attachment, has in a few years established itself as one of the best-selling common cold products in Swedish pharmacies. Today the product is marketed and sold in Sweden, Denmark, Norway, Finland, Iceland, UK and Spain. The company is in negotiations with a number of potential distributor for the launch of ColdZyme in other markets. In the beginning of November Enzymatica signed an exclusive distribution agreement with Endeavour Consumer Health for Australia and New Zealand for marketing and sales of ColdZyme.

For more information, please contact:

Fredrik Lindberg, CEO Enzymatica AB
Tel: +46 708-86 53 70 | E-post: fredrik.lindberg@enzymatica.com

This information is information that Enzymatica AB (publ) 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 above, at 09.00 CET on December 21, 2016.

About Enzymatica AB
Enzymatica is a life science company who develops and sells medical device products against infectious-related diseases. Over a short period the company has developed a unique oral spray for colds, ColdZyme®, and launched it on seven markets. The product has become one of the leading articles for colds in Swedish pharmacies. Enzymatica's strategy is to continue growing by strengthening its position in existing markets and to expand to more geographical markets through well-established partners. The company is headquartered in Lund, Sweden and is listed on Nasdaq First North. For more information, please visit www.enzymatica.com.   

Enzymatica's certified advisor is Erik Penser Bankaktiebolag