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Saniona AB: Saniona plans to initiate Phase 2a study in Prader-Willi in 2017


November 7, 2016

Saniona, a leading biotech company in the field of ion channels, today
announces that it has filed a clinical trial application in Czech Republic
and Hungary for the performance of a Phase 2a study for Tesomet in patients
with Prader-Willi Syndrome (PWS) during the first half of 2017. This new
study will be executed independent of the current study in patients with type
2 diabetes and is expected to take approximately a year. The PWS study may
potentially pave the way for initiating a Phase 3 study. PWS is an orphan
disease and Saniona plans to apply for orphan disease designation to both the
EMA and FDA in the near future.

"The investment in a Prader-Willi study is a new and decisive step for
Saniona. We see great potential for Tesomet in this indication since it may
solve serious problems for a group of patients that currently lack
possibilities for treatment. The study can be carried out within the
framework of present financing," says Jørgen Drejer, CEO at Saniona.

Prader-Willi Syndrome is a rare genetic disorder with among other things an
extreme and insatiable appetite as one of its hallmarks. Patients affected by
this condition start gaining weight in childhood and especially during
puberty which leads to greatly accelerated development of obesity, type-2
diabetes, CV disease and ultimately premature death. There is no cure today.

Tesomet is a combination of tesofensine and metoprolol, which currently is
being tested in a Phase 2a study for treatment of type 2 diabetes. The
recruitment was finalised in August and top line data is expected to be
available early 2017.

Administration of tesofensine, one of the active ingredients in Tesomet, was
investigated in a Phase 2 study where it demonstrated a pronounced and highly
statistically significant weight loss in obese patients. It is believed that
this large magnitude of weight loss is driven by the triple mode of action
including normalization of the appetite, reduction in the craving for food
and an increase in fat utilization. Due to the mode of action of Tesomet,
Saniona believes that it potentially may be used for treatment of a number of
metabolic syndromes and eating disorders including PWS, binge eating, type 2
diabetes and fatty liver diseases including NASH.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957,

This information is information that Saniona (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 08:00
CET on November 7, 2016.

About Saniona

Saniona is a research and development company focused on drugs for diseases of
the central nervous system, autoimmune diseases, metabolic diseases and
treatment of pain. The company has a significant portfolio of potential drug
candidates at pre-clinical and clinical stage. The research is focused on ion
channels, which makes up a unique protein class that enables and controls the
passage of charged ions across cell membranes. Saniona has ongoing
collaboration agreements with Boehringer Ingelheim GmbH, Upsher-Smith
Laboratories, Inc., Productos Medix, S.A de S.V and Saniona's Boston based
spinout Ataxion Inc., which is financed by Atlas Venture Inc. and Biogen Inc.
Saniona is based in Copenhagen, Denmark, where it has a research center of
high international standard. Saniona is listed at Nasdaq First North Premier
and has about 4,400 shareholders. Pareto Securities is Certified Advisor for
Saniona. The company's share is traded under the ticker SANION. Read more at

About Prader-Willi Syndrome (PWS)

Prader-Willi Syndrome (PWS) is recognized as the most common genetic cause of
life-threatening obesity. The disease results from a deletion or loss of
function of a cluster of genes on chromosome 15, which leads to dysfunctional
signaling in the brain's appetite/satiety center (hypothalamus). Patients
suffer from a constant, extreme, ravenous insatiable appetite which persists
no matter how much the patients eat. As a result, many of those affected with
PWS become morbidly obese and suffer significant mortality. Compulsive eating
and obsession with food usually begin before age 6. The urge to eat is
physiological, overwhelming and difficult to control. Caregivers need to
strictly limit the patients' access to food, usually by installing locks on
refrigerators and on all closets and cabinets where food is stored.
Currently, there is no cure for this disease. Patients with PWS have a
shortened life expectancy. Common causes of mortality in PWS include
respiratory disease, cardiac disease, infection, choking, gastric rupture,
and pulmonary embolism. However, if obesity is avoided and complications are
well managed, life expectancy for individuals with PWS is normal or near
normal and most individuals can lead healthy lives[1]. PWS occurs in
approximately one out of every 15,000 births[2]. Males and females are
affected equally. The condition is named after Andrea Prader, Heinrich Willi,
and Alexis Labhart who described it in detail in 1956. The common
characteristics defined in the initial report included small hands and feet,
abnormal growth and body composition (small stature, very low lean body mass,
and early-onset childhood obesity), hypotonia (weak muscles) at birth,
insatiable hunger, extreme obesity, and intellectual disability.
[1]Butler MG, Lee PDK, Whitman, BY. Management of Prader-Willi Syndrome. 3rd
ed. New York, NY: Springer Verlag Inc.; 2006. 0387253971
[2] for
Prader-Willi Research retrieved October 2016

20161107 - PR - Prader Willi - UK

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Saniona AB via Globenewswire

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