Biofrontera speeds drug development through microdosing
UK-based Xceleron, a pioneer in methods of accelerating drug development, is to carry out a Phase 0 microdose study with Biofrontera Bioscience, a developer of drugs for the treatment of dermatological and inflammatory diseases.
UK-based Xceleron, a pioneer in methods of accelerating drug development, is to carry out a Phase 0 microdose study with Biofrontera Bioscience, a developer of drugs for the treatment of dermatological and inflammatory diseases.
The study's purpose is to administer sub-pharmacological dose levels of promising drug candidates in human volunteers in order to gain critical pharmacokinetic information which in turn will enable the most promising drug candidates to be progressed to Phase I trials.
Dr Reinhold Gahlmann, md of Biofrontera Bioscience, said: "Our collaboration with Xceleron, and the use of their highly innovative approach, will save Biofrontera significant time and cost, allowing us to focus resources on our most promising preclinical drug candidates going forward."
Xceleron will co-ordinate the complete microdose project from synthesis through clinical trials (with Dutch clinical partners Pharma Bio-research) and finally zeptoanalysis at the company's laboratories in York, UK using ultra-sensitive accelerator mass spectrometery (AMS) - the world's most sensitive measuring device that enables the microdosing concept.
Microdosing is "fast becoming an accepted approach in drug development with the interface between preclinical and clinical trial stages radically changing", said Professor Colin Garner, Xceleron's ceo.
As many as one in three drugs fail in Phase I clinical testing despite extensive pre-clinical screening of potential clinical candidates with a wide variety of in silico, in vitro, ex-vivo and animal models. A high proportion of failures can be attributed to sub-optimal pharmacokinetics (PK) leading to potential efficacy or safety issues in humans.
There is general recognition by the pharma industry that more clinical information needs to be gathered earlier than currently practiced.
Based in Leverkusen, Germany, Biofrontera has three product candidates in clinical development for four different clinical indications. The most advanced products are BF-200 ALA (Phase IIb/III) for actinic keratosis and condyloma; and BF-derm 1 (Phase II) for chronic, antihistamine-refractory urticaria. The third clinical candidate, BF-37, currently enters phase II development for atopic dermatitis.
