Biovitrum
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.