STOCKHOLM – August 27, 2013. Today Lipidor announced positive results from a
Phase I/IIa study investigating the efficacy and tolerability of its
AKVANO®/calcipotriol spray formulation for the treatment of psoriasis vulgaris,
the most common form of psoriasis. Karolinska Development owns 50% of Lipidor.
“The positive study results represents an important milestone for Lipidor in its
efforts to develop a product with equivalent clinical efficacy compared to
market leading calcipotriol-only topical treatments, and with superior cosmetic
qualities and greater ease of use, thereby, improving compliance rates and
patient quality of life”, concludes Anders Carlsson, CEO of Lipidor.
Various kinds of ointments, creams and lotions are commonly prescribed
treatments for psoriasis, but they also show low compliance rates. This is
largely due to their greasiness and inability to absorb into the skin and
therefore be present on the skin for a long time after application. This causes
personal discomfort as well as staining of clothes.
Lipidor is developing AKVANO®/calcipotriol, a water-free spray formulation
containing calcipotriol, a vitamin D derivative that is one of the cornerstones
in the treatment of mild to moderate psoriasis vulgaris. The AKVANO® technology
enables efficient delivery of the pharmaceutical ingredient. After application
the carrier compounds evaporates quickly, leaving a pleasant feeling on the skin
and a cosmetically appealing result.
Data from the recently concluded Phase I/IIa clinical study in 24 psoriasis
vulgaris patients revealed that the AKVANO®/calcipotriol spray formulation had
clear and significant antipsoriatic effects compared to placebo, comparable to a
marketed formulation of calcipotriol. This means that the primary objective of
the trial was met. In the study, the patients received 10 topical treatments
over 12 days. No safety issues were noted in the study.
Approximately 125 million patients suffer from psoriasis worldwide. While the
disease varies in its manifestation, psoriasis vulgaris that affects 80-90% of
the patients typically causes plaques of rapid skin accumulation at certain
areas of the skin. One of the measures of disease severity is the body surface
area covered by affected skin plaques or lesions, from distinctly localized to
widespread. Psoriasis can cause itching and pain, scaling of skin and bleeding
lesions. Quality of life aspects, including self-consciousness and social
withdrawal are important factors in the management of the disease including
treatment compliance.
For further information, please contact:
Anders Carlsson, CEO, Lipidor AB
Phone: +46 (0)73 778 06 43, e-mail: anders.carlsson@lipidor.se
Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com
Benjamin Nordin, IRO, Karolinska Development AB
Phone: +46 (0)73 093 60 80, e-mail: benjamin.nordin@karolinskadevelopment.com
TO THE EDITORS
About Lipidor
Lipidor is a drug delivery company focusing on topical treatment. Its
proprietary AKVANO® technology can accommodate most drug substances used for
topical treatment in its novel sprayable dosage form. The lead product concept
is a sprayable AKVANO®-based product concept with calcipotriol being developed
for psoriasis vulgaris. The company is also evaluating a similar AKVANO®-based
product concept with a combination of calcipotriol and a corticosteroid for the
same indication.
About the clinical trial
The primary objective of the Phase I/IIa clinical trial was met since
AKVANO®/calcipotriol showed clear and significant antipsoriatic effects,
measured by sonography as a reduction in infiltrate thickness, in comparison to
corresponding vehicle formulations. A secondary objective was also met since the
antipsoriatic effects were comparable to that of the marketed product Daivonex®
solution. 24 patients (male and female) were included in the study.
About Karolinska Development AB
Karolinska Development aims to create value for patients, researchers, and
investors by developing innovations from world class science into products that
can be sold or out-licensed with high returns. The business model is to: SELECT
the most commercially attractive medical innovations; DEVELOP innovations to the
stage where the greatest return on investment can be achieved; and COMMERCIALIZE
the innovations through the sale of companies or out-licensing of products. An
exclusive deal flow agreement with Karolinska Institutet Innovations AB, along
with other cooperation agreements with leading universities, delivers a
continuous flow of innovations. Today, the portfolio consists of 35 projects, of
which 16 are in clinical development. For more information, please visit
www.karolinskadevelopment.com.
Karolinska Development is listed on NASDAQ OMX. Karolinska Development may be
required to disclose the information provided herein pursuant to the Securities
Markets Act.
