Bli medlem
Bli medlem

Du är här

2016-12-21

Saniona AB: Saniona's tesofensine partner, Medix, files application for Phase 3 clinical trials in obesity

PRESS RELEASE

December 21, 2016

Saniona, a leading biotech company in the field of ion channels, today
announces that Productos Medix, S.A de S.V (Medix) has filed a clinical trial
application in Mexico for the initiation of a Phase 3 study for tesofensine
in obese Mexican patients.

"We are looking forward to initiate this Phase 3 clinical trial for
tesofensine, which has shown outstanding efficacy and good tolerability in
Phase 2 clinical trials for a severe health problem in Mexico. We have
submitted a protocol for review by the authorities. The protocol and
documentation will be reviewed in the near future together with the
authorities to ensure that the planned study will fulfil the requirement for
a market authorisation in Mexico," says Carlos López Patán, CEO of Medix.

"By initiating Phase 3 clinical trial for tesofensine in obesity, Medix may
potentially be the first company to introduce one of Saniona's product
candidates to the market. In the medium term, this may lead to a stable
income stream to Saniona through royalties on product sales in Mexico and
Argentina. Moreover, Saniona will have the exclusive rights to use the
clinical data developed by Medix in the rest of world," says Jørgen Drejer,
CEO of Saniona.

Medix has ordered the tablets to be used in the study and will file for an
import license when the Phase 3 application has been approved by the Mexican
authorities.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957,
E-mail:tf@saniona.com

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 December 21, 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. 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
www.saniona.com.

About Productos Medix, S.A de S.V (Medix)

Medix is a Mexican pharmaceutical company established in 1956. Medix is
primarily focused on treatment of overweight and obesity. The company is the
market leader for treatment of overweight and obesity in Mexico where it
offers the most comprehensive product and service line. Medix's leading
product for treatment of overweight and obesity is among the top ten
pharmaceutical products in Mexico overall. Medix has earned several
recognitions for its social responsibility through its participation in
philanthropic programs for the benefit of the Mexican population and for its
educational efforts involving thousands of doctors in Mexico. The company has
subsidiaries in Argentina and certain other South American countries.

About overweight and obesity in Mexico

Mexico ranks the most obese country in the world. It is estimated that more
than 70% of the 128 million Mexicans are overweight and that more than 30%
are clinical obese. Since the 1990s, fat has become the principal source of
energy in the Mexican diet and it is assumed that the consumption of highly
processed food will continue increasing. Consequently, Mexico has seen the
same kind of health issues that other countries with overweight populations
have. Standardized mortality rates (SMR) for diabetes, acute myocardial
infarction (AMI), and hypertension have increased dramatically. As of 2012,
diabetes - associated with obesity - was the largest single killer in Mexico.

Obesity is characterised by severe excess weight in the form of fat and is
defined on the basis of a measure referred to as Body Mass Index (BMI). A BMI
of more than 30 is referred to as clinical obesity, while a BMI of 25-30
expresses excess weight. Obesity is a serious clinical condition that
involves a notably increased risk of cardiovascular diseases and the
development of type 2 diabetes. According to the World Health Organization,
obesity has reached epidemic proportions worldwide with more than one billion
overweight adults of whom at least 300 million are clinically obese. Today,
there is a strong medical need for more effective treatment options for
obesity.

About tesofensine

Tesofensine, a monoamine uptake inhibitor, is focused on obesity. Tesofensine
has been evaluated in Phase 1 and Phase 2 human clinical studies with the aim
of investigating treatment potential with regards to obesity, Alzheimer's
disease and Parkinson's disease. Tesofensine demonstrated strong weight
reducing effects in Phase 2 clinical studies in obese patients. In general,
tesofensine has been administered to more than 1,200 patients and is well
tolerated.

Mode of Action - Tesofensine potentiate dopamine

Pathological overeating and obesity can be caused by decreased dopamine
function in the reward centre of the brain. Dopamine transporter proteins are
inhibited by tesofensine, so the dopamine receptors are stimulated for a
longer period after activation and the brain's reward system is amplified.
With a similar mechanism of action tesofensine also increases levels of two
other monoamines, serotonin and noradrenaline.

Each of these transmitters exert an important function on appetite and
metabolism at different locations in the brain. Dopamine acts in the nucleus
accumbens of the forebrain to modulate reward and the "pleasure"-feeling of
food. The two other transmitters act in the hypothalamus to increase
metabolism and reduce appetite.

The unique efficacy of tesofensine in obesity may be explained by reversal of
blunted dopamine response in obese patients. In obese individuals, the brain
centre (striatum) controlling consummatory food reward dopamine receptors are
reduced relative to lean individuals. It has been found that in the relevant
brain region more than 70% of obese individuals have a blunted dopamine
response to food intake.

Clinical Programs - Tesofensine has produced superior weight loss data.

The clinical Phase 2b trial (TIPO-1) reported in The Lancet showed levels of
weight loss over a six-month period that were of high clinical relevance and
highly competitive to other approaches. Patients lost an average of 12.8 kg
on a 1 mg dose, 11.3 kg on a 0.5 mg dose and 6.7 kg on a 0.25 mg dose
compared with a 2.2 kg loss in the placebo group. All participants were
instructed to follow a diet with a 300 kcal deficit and to increase their
physical activity gradually to 30-60 minutes of exercise per day. Of the
patients receiving 0.5 mg daily, considered the relevant therapeutic dose,
87% of the patients (58% versus placebo) achieved more than 5% weight loss
and 53% of the patients (46% versus placebo) achieved a weight loss of more
than 10% after 6 months follow up.

There has also been reported interim results from a 48-week, open-label
extension trial (TIPO-4) in which 140 patients who completed the 24-week
Phase 2b trial (TIPO-1) were re-enrolled after an average of three months'
wash-out. All of them were then treated with 0.5 mg tesofensine once daily
but up-titration to 1 mg once daily was allowed in the first 24 weeks of the
extension study. The 24-week interim results for those who were previously
treated with 0.5 mg tesofensine in TIPO-1 showed a total mean weight loss of
between 13 kg and 14 kg over 48 weeks of treatment. Furthermore, TIPO-4
confirmed the TIPO-1 results since the patients who were previously treated
with placebo lost approximately 9 kg in the first 24 weeks of the TIPO-4
study.

20161221 - PR - Medix Phase 3 - UK
http://hugin.info/172499/R/2066630/775859.pdf

---------------------------------------
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

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.