Biovitrum has Completed an Exploratory Clinical Phase II Study in
Glaucoma
Biovitrum has completed a first explorative clinical Phase II study
with the candidate drug BVT.28949, a 5-HT2A antagonist intended for
the treatment of glaucoma. The preliminary results show a dose
dependent reduction of the intraocular pressure; a reduction that
amounted to 10 % as compared to the pressure before treatment after
four weeks at the highest dose.
The objective of the present explorative phase II study was to
validate a novel mechanism (mediated via the 5-HT2A receptor) for the
treatment of glaucoma, for the first time using a selective
antagonist (BVT.28949). The study included 129 patients with an
elevated intraocular pressure, with or without developed glaucoma.
The study was double-blind 1, randomized 2, placebo-controlled 3 and
was carried out at several clinics in both Sweden and Ukraine.
The results show that BVT.28949 reduces the intraocular pressure and
that the reduction is dose dependent. After 2 weeks of treatment a
statistically significant reduction of the pressure as compared to
placebo (p<0.003) was obtained at the highest dose, 7 mg/ml. At the
end of the treatment, after 4 weeks, the reduction in pressure in
that dose group was 10 % from starting pressure. However, the
reduction was no longer statistically significantly different from
placebo (p<0.067). The treatment was tolerable and safe.
- It is with satisfaction we have completed this explorative study
and thus successfully validated a novel target for the treatment of
glaucoma. The results from the study will now be further analyzed.
Our ambition is to approach other companies to discuss an
out-licensing of the project, which is fully in line with our
strategy," says Martin Nicklasson, CEO of Biovitrum.
Glaucoma is a disease characterized by damage to the optic nerve and
it is in most cases accompanied by an increased pressure within the
eye. The current hypothesis is that BVT.28949 reduces intraocular
pressure by stimulating the outflow of aqueous humor through a
mechanism different from that of presently available products. It is
estimated that nearly 70 million people worldwide suffer from
glaucoma. The total market value for this type of medicines amounts
to approximately $3.9 billion.
1 Neither patients nor researchers know who belongs to the control
group and the experimental group during the active phase of the
trial.
2 Patients are divided between experimental and control groups at
random.
3 Results will be compared with results from individuals treated with
an agent without any actual medicinal effect; the control group.
For further information please contact:
Biovitrum AB (publ)
Martin Nicklasson, CEO
Phone. +46 8 697 20 00
martin.nicklasson@biovitrum.com
Göran Arvidson, CFO
Phone: +46 8 697 2368, Mobile: +46 70 633 30 42
goran.arvidson@biovitrum.com
Erik Walum, Director Science Communication
Phone. +46 8 697 32 40, Mobile: +46 70 312 90 75
erik.walum@biovitrum.com
Facts to the editor
About Biovitrum
Biovitrum is one of the largest biopharma companies in Europe. With
operations in Sweden and in the UK Biovitrum conducts research and
develops pharmaceuticals for unmet medical needs both for conditions
that affect smaller patient populations and for common diseases.
Biovitrum has currently a broad and balanced R&D portfolio with
several projects in clinical and preclinical phases for a number of
well defined specialist indications as well as for common diseases
within obesity, diabetes, inflammation, eye and blood diseases.
Biovitrum develops and produces protein-based drugs on a contractual
basis and markets a range of specialist pharmaceuticals primarily in
the Nordic countries. Biovitrum has revenues of approximately SEK 1.2
billion and around 500 employees. Biovitrum's share is listed on the
OMX Nordic Exchange in Stockholm since September 15, 2006. For more
information see www.biovitrum.com.
About BVT.28949
While several effective treatments exist for decreasing intraocular
pressure, they do not successfully control glaucoma in a significant
number of patients. According to Biovitrum's opinion there is a need
for glaucoma treatments acting through novel mechanisms, with the
potential to be used as a second-line monotherapy or in combination
with current therapies.
BVT.28949 is a selective 5-HT2A antagonist (serotonin receptor 2A
antagonist), suitable for topical administration in the form of eye
drops. 5-HT2A-receptors control the outflow of aqueous humor from the
eye globe. BVT.28949 lowers the intraocular pressure by increasing
the outflow of aqueous humor and Biovitrums current hypothesis is
that BVT.28949 acts through stimulation of outflow via the trabecular
meshwork, unlike prostaglandins (e.g. Xalatan®) which reduce
intraocular pressure through another outflow mechanism.