Biotest AG: Monoclonal antibody BT-061 shows potential in the indication multiple sclerosis
Biotest has obtained positive pre-clinical data indicating the potential of BT-061 for the treatment of multiple sclerosis (MS). Current scientific publications by academic research groups show that the regulatory T-cells in particular play a central part in the development and progression of MS; impairment of their function in the patient appears to be causally linked with the disease. The monoclonal antibody BT-061 specifically activates regulatory T-cells. The pre-clinical data that have now been obtained show that BT-061 reinforces the function of regulatory T-cells derived from MS patients.
'We are very pleased that the data now available confirm our expectations that the immunomodulatory mechanism of action of BT-061 has considerable potential in the indication MS,' comments Dr. Frank Osterroth, director of the Biotherapeutics Division at Biotest, on the data.
Further pre-clinical analyses are now aimed at preparing for the clinical trial of BT-061 in the indication MS. Evidence is to be sought on which patient populations might respond particularly well to therapy with BT-061. The analyses will be conducted in collaboration with leading academic study groups working in this area.
To deal with this and other questions, Biotest has joined the 'New active agents for neurological diseases' consortium (Neu² Konsortium). This is a consortium of institutes and pharmaceutical companies that work on the development of new active agents to treat neurological diseases, supported by the German Federal Ministry of Education and Research (BMBF). The consortium represents an optimal platform for further studies focused on clinical development.
The decision-making body of the Neu² Konsortium voted unanimously to support the development programme of BT-061 in MS and this decision has now been confirmed by the BMBF.
The approved support programme extends over a three-year period and may also include a phase IIa clinical trial, which will investigate the potential of BT-061 in patients with MS (proof-of-concept trial).
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