Enzymatica AB: Top-line results of new clinical trial
December 21 2016 - 3:00AM
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
Enzymatica Press Release Top-line
results of new clinical trial
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The issuer of this announcement warrants that they are solely
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information contained therein.
Source: Enzymatica AB via Globenewswire
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