Intensive Search for Novel Antiviral and Antibacterial Agents

Given the rise of resistance towards commonly used antibacterial and antiviral drugs, AiCuris' research & development (R&D) strategy is based on discovery and development of novel and resistance-breaking therapies. Therefore, AiCuris' R&D portfolio nearly exclusively comprises compounds with a novel mechanism of action and/or originating from new chemical classes. AiCuris has a broad clinical portfolio, currently developing two projects in phase II, five projects in phase I, and one project in phase 0. Additional research projects in virology and bacteriology sustain a continuous and balanced pipeline of innovative drug candidates.

It is AiCuris' vision to combine innovative science and accelerated clinical development to create resistance-breaking therapies against bacterial and viral infections.

To realize this vision, AiCuris has implemented a culture of performance- and data-driven decisions to increase project success rates and reduce overall development time. A key component of this culture is AiCuris' R&D strategy based on the following principles:

Research & Preclinical Development

Preclinical development at AiCuris is linked seamlessly to the learning phase in clinical development and provides essential data 1) on the mechanism of action of a drug candidate allowing a high likeliness to demonstrate higher efficacy over available therapies including breaking existing resistances; 2) to improve understanding of the exposure-response relationship and predict human drug exposure; 3) to identify the toxicity profile and the risk for drug-drug interactions early.

Clinical Development

In the clinical development, understanding of a new drug candidate is optimized by a number of phase I trials including identification of human metabolites, the maximum tolerated dose, the food effect, the interaction potential and the drug's safety profile in humans. In addition, formulation development will ensure that the formulation used in phase II is close to the final formulation. These trials may be completed in parallel to a proof-of-concept trial (phase Ib or IIa) designed to demonstrate that the drug candidate is capable of meeting the specific medical need in a representative patient population and is likely to fulfil its product target profile. This phase is followed by a dose-finding phase II.

Because the "learning phase" results in a through characterisation of the compounds form novel chemical classes including drug-drug interaction studies, phase III can be designed based on solid data covering all important properties of a drug and success in phase III is expected to be above average.

Immunology

Besides its key R&D areas, virology and bacteriology, AiCuris also works on new therapies to help the body's immune system defeat viral and bacterial infections. One of these projects is aimed at supporting antiviral drugs by improving the immune response towards viruses like HCV and HIV. The other project targets autoimmune diseases.