NeuroSearch reports final results from the TIPO-2 study with tesofensine in obesity

Hvidovre, DENMARK


Announcement


NeuroSearch reports final results from the TIPO-2 study with tesofensine in
obesity 

- Results show that tesofensine's outstanding efficacy in weight reduction is
obtained through both appetite suppression and a favourable impact on energy
and fat 
metabolism 
- The positive results strongly support tesofensine's potential as a superior
new treatment of obesity and type 2 diabetes 

NeuroSearch has concluded the detailed evaluation of the data from TIPO-2, a
human metabolic study with tesofensine, a monoamine reuptake inhibitor, in
development for the treatment of obesity and type 2 diabetes. The results show
that tesofensine significantly increases feelings of satiety and decreases the
desire to eat while impacting favourably also on energy expenditure and fat
metabolism in overweight and obese subjects. These synergistic effects are
likely to help explain the outstanding efficacy of tesofensine in body weight
management observed in both TIPO-2 (placebo-controlled mean weight loss of 1.8
kg after 14 days) and other clinical studies, including TIPO-1
(placebo-controlled mean weight loss of 9.2 kg after 24 weeks), and TIPO-4
(additional mean weight loss of approx. 4 kg after 24 weeks' treatment
extension to TIPO-1). 

TIPO-2 was designed as a randomised, double-blinded, placebo-controlled,
parallel-group study, in which 32 overweight and obese subjects with a BMI
(Body Mass Index (kg/m2)) of 28-35 were treated for 14 days with either
tesofensine (with an accelerated daily dosing scheme of up to 1 mg exposure) or
placebo. The aim of the study was to evaluate tesofensine's effect on selected
metabolic parameters by means of measurement of energy expenditure, fat
oxidation and subjective appetite sensation (visual analogue scales (VAS)
scores), DEXA scanning, and biochemical blood analyses. 

Main conclusions from the evaluation of tesofensine's metabolic effects in
TIPO-2: 

• Tesofensine reduces appetite sensations 
In line with earlier clinical data from TIPO-1, the subjective appetite
sensations measured after 14 days' treatment in TIPO-2 showed that subjects in
the tesofensine treated group had an increased feeling of satiety with less
desire to eat than subjects in the placebo group (p<0.05). 

• Tesofensine significantly increases fat oxidation and reduces fat tissue 
In the tesofensine treated group, 24-hour fat oxidation was increased by 15%
(p<0.05), while, reassuringly, 24-hour protein oxidation was lower compared
with the placebo group (p<0.05). Also, results from DEXA scanning show a
statistically significantly greater loss of fat tissue in the tesofensine
treated subjects than under placebo (p<0.01). 

• Tesofensine increases levels of adiponectin and improves insulin sensitivity 
The significant loss of fat in the tesofensine-treated subjects was also
reflected in a higher level of adiponectin in their blood. Adiponectin is a
peptide hormone secreted exclusively by fat cells (adipocytes). Adiponectin
decreases free fatty acids in the blood (plasma triglycerides) and increases
glucose metabolism by improved insulin sensitivity, thereby also playing an
important role in the treatment of type 2 diabetes. 

• Tesofensine increases energy expenditure at rest 
After 14 days, a significant increase of 6% in night time energy expenditure
was observed in the tesofensine treated group compared with placebo (p<0.05).
The observed increase could not be explained by differences in body weight or
spontaneous physical activity, indicating a direct effect of tesofensine on
energy expenditure at rest. 

The synergistic effects of tesofensine as observed in TIPO-2 with positive
modulation of appetite sensations combined with increased energy expenditure
and fat metabolism are likely to explain the pronounced effect on body weight
(fat tissue reduction) and with improved glucose metabolism observed both in
the present and previous studies. In line with the data from TIPO-1 where
approximately 80% of the observed weight loss was related to body fat
reduction, the detailed results from TIPO-2 show that tesofensine exerts its
effect on energy metabolism via loss of fat and not by increased muscle
degradation or other catabolic effects in the organism. 

Hence, the findings from TIPO-2 strongly support tesofensine's potential as a
superior new treatment of obesity and type 2 diabetes. 



Thomas Hofman-Bang
Chairman of the Board



Contact persons:
Flemming Pedersen, CEO, telephone: +45 4460 8214 or mobile: +45 2148 0118
Hanne Leth Hillman, VP, Director of Investor Relations and Corporate
Communications, telephone: +45 4460 8212 or mobile: +45 4017 5103 


NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on the
OMX Nordic Exchange Copenhagen A/S. The company's core business covers the
development of novel drugs, based on a broad and well-established drug
discovery platform focusing on ion channels and CNS disorders. A substantial
part of the activities are partner financed through a broad alliance with
GlaxoSmithKline (GSK) and collaborations with among others Abbott and Astellas.
NeuroSearch's drug pipeline comprises 14 clinical (Phase I-III) development
programmes: ACR16 in Huntington's disease (Phase III), tesofensine in obesity
and in type 2 diabetes (Phase III in preparation), NS2359 in depression (Phase
II) and ADHD (Phase II) in partnership with GSK, ABT-894 in ADHD (Phase II) and
pain (Phase II) in partnership with Abbott, ACR16 in schizophrenia (Phase I) in
partnership with Astellas, ACR325 in Parkinson's disease (Phase II in
preparation) and bipolar disorder (Phase II in preparation), ABT-107 as well as
ABT-560 for the treatment of various CNS disorders - both (Phase I) in
collaboration with Abbott, NSD-644 in pain (Phase I) in partnership with GSK,
ACR343 in Parkinson's disease (Phase I) and NSD-788 in anxiety/depression
(Phase I). In addition, NeuroSearch has a broad portfolio of preclinical drug
candidates and holds equity interests in several biotech companies.

Attachments

fonds.29-08 - tipo-2 final results - uk_final.pdf