Ameluz® is to be approved for further skin diseases in the coming years as well as in other parts of the world.
Clinical trials must be conducted for further indications to be approved. Which trials are conducted for which new indications is a matter determined in close coordination with the respective regulator.
In the near future, Biofrontera is aiming for the US approval of Ameluz® for superficial basal cell carcinoma as well as new indications for actinic keratosis for areas beyond the face and scalp.
The active principle of Ameluz® enables the application of the medication in various further indications, for which the company is developing specific strategies.
BF-derm1 for chronic, antihistamine-refractory urticaria (clinical phase II)
BF-derm1 is a tablet containing a novel, irreversible histidine decarboxylase inhibitor that in cells blocks the synthesis of histamine, a major trigger of allergic symptoms. BF-derm1 is in development for the treatment of chronic, antihistamine-refractory urticaria.
The efficacy of BF-derm1 was already demonstrated in a phase IIa trial. Taking BF-derm1 improved the symptoms of urticaria and patients required substantially less sedating antihistamines to fight their itching.
BF-1 for migraine prophylaxis (clinical phase I)
BF-1 is a highly specific serotonin receptor antagonist. This substance is developed as tablet for migraine prophylaxis. Migraine is an inflammatory reaction of the meninges. BF-1 has shown excellent efficacy in a mouse model for migraine genesis. A human trial was performed already to examine the uptake of BF-1 from the tablet into the blood (bioavailability), and its distribution, degradation and secretion (biokinetics). Due to the high stability of the compound in the human body the intake of one tablet per day is sufficient to maintain a constant level of the active compound in the blood.