The research team at AOP Health covers all essential aspects of product development, starting with preclinical research and extending to toxicology, pharmaceutical development, clinical development, regulatory affairs, quality management, pharmacovigilance, and project management. Experts in the individual specialties work as project managers in close cooperation with each other and with external service providers and partners, in order to implement the ambitious research projects of the organization.
Pipeline.
| Indication | Pre-Clinical | Phase I | Phase II | Phase III | Phase IV | |
|---|---|---|---|---|---|---|
| Therapy-resistant chronic venous ulcer (CVU) wounds | ||||||
| Indication | Pre-Clinical | Phase I | Phase II | Phase III | Phase IV | |
|---|---|---|---|---|---|---|
| Recessive dystrophic Epidermolysis bullosa, Junctional Epidermolysis bullosa | ||||||
| Indication | Pre-Clinical | Phase I | Phase II | Phase III | Phase IV | |
|---|---|---|---|---|---|---|
| Solid tumors and lymphomas | ||||||
| Acute myeloid leukemia and myelodysplastic syndrome |
| Study Name / Substance | Indication | Pre-Clinical | Phase I | Phase II | Phase III | Phase IV | |
|---|---|---|---|---|---|---|---|
| BESREMi-PASS | Polycythemia vera | ||||||
| BOSUPEG | Chronic myeloid leukemia | ||||||
| ROP-ET | Essential thrombocythemia | ||||||
| FEDORA | Myelofibrosis |
| Study Name / Substance | Indication | Pre-Clinical | Phase I | Phase II | Phase III | Phase IV |
|---|---|---|---|---|---|---|
| HYPER BETASHOCK | Septic shock | |||||
| MILANOS | Septic shock | |||||
| LANDIPROTEC | POAF prevention | |||||
| LANDI-POAF | POAF prevention | |||||
| LUNA | LCOS prevention |
| Study Name / Substance | Indication | Pre-Clinical | Phase I | Phase II | Phase III | Phase IV |
|---|---|---|---|---|---|---|
| TRIPLE TRE | Pulmonary arterial hypertension | |||||
| TRE PAED | Pulmonary arterial hypertension |
Significance of the phases
The tolerance and safety of the drug are tested in a phase-I study. Those conducting the study investigate how the active substance is absorbed by the body and draw preliminary conclusions about the appropriate dosage. The trial is conducted in a small group of healthy probands or severely ill patients.
The aim of this study phase is to obtain evidence of the efficacy of the tested drug and to confirm the therapy concept. Based on the results of the first study phase, another point of focus in phase II is the determination of the optimal dose, which is then used in phase III. The investigations are conducted in a precisely defined and limited group of patients.
Based on large-scale trials, in this phase the investigator obtains decisive data for the approval of the drug. The study conditions should be such that they largely concur with the subsequent therapy situation. The study includes a large number of patients who are then divided into randomized comparative groups and receive the new active substance or an already approved drug or a placebo. This permits a direct comparison of the employed substances.
Phase IV trials consist of further clinical studies performed with the already approved drug. By treating a much larger group of patients, in this phase it is possible to identify and register rare side effects as well as interactions with other drugs and optimize the use in the approved indication.
Dr. Martin Unger
A trustful relationship with investigators and study staff in every single center, quick communication, competence synergies – all of these aspects are of vital importance for the success of our studies.
Dr. Christoph Klade
AOP Health has successfully developed a number of innovative treatment options in recent years. To arrive at these, our thinking is guided above all by patient needs.