A new therapeutic strategy is pursued by the monoclonal antibody BT-061 (link to BT-061) from Biotest, which is currently in clinical development. Based on current knowledge, BT-061 has an influence on superimposed regulatory mechanisms.
 
The antibody attaches to an important immunological control center, the regulatory T cells (Tregs), whose control function malfunctions in autoimmune diseases.
 
The antibody attaches to a structure on the surface of the Tregs and thus most likely restores their efficiency/efficacy. BT-061 presumably has the effect, through the targeted activation of Tregs that previously dysfunctional natural control mechanisms are reactivated, so that the body is able to counteract the dangerous autoreactive T cells by itself.
 
Since BT-061, based on the current knowledge, only supports natural control routes and does not impose non-physiological reactions on the immune system, Biotest assumes that the effects of this antibody are particularly efficient and safe. Good tolerability and a safe dosage have already been confirmed in preclinical and initial clinical studies. Efficiency and tolerability are currently being examined in a Phase-II study on 48 psoriasis patients (development status). Patient recruitment is concluded and the trial is being currently analyzed.

 
If these expectations are fulfilled, Biotest will realize the further clinical development together with a strategic partner. Due to the increased medical need and the expected natural mode of action of BT-061, Biotest currently anticipates a high degree of market acceptance. Since the target cells of BT-061, the regulatory T cells (Tregs) are also dysfunctional in the case of other autoimmune diseases as well as some allergies, it is likely that the scope of indications for the Biotest antibody will be extended further in the future (BT-061/other possible indications).