Collectively, the TherapeutAix team has a successful track record in the cardiovascular, inflammation, immunology, neuroscience, respiratory, pain, tissue repair and urology areas. Within this broad expertise, we have recently helped clients progress projects in fibrotic diseases, inflammatory and CNS indications, including large as well as rare/orphan and niche indications.
Our clients include academic spinouts, biotech, mid-size and large pharma, investors and university tech transfer offices. We have supported regional development offices and organisations analysing strategic trends in the field as well as competitors. Additionally, we’ve helped clients analysing their capabilities to support strategic capacity build.
We have worked extensively in fibrotic diseases including NASH and rare diseases and orphan indications, such as IPF. We have experience working with small and large molecules and specialise in biomarkers and translational science. Our contemporary understanding and practical capabilities in the fibrosis area is captured in our growing list of co-authored publications and presentations. Our recent experience and connections make us ideally placed to help define positioning strategies for assets in fibrotic diseases. We have worked with a number of asset holders to design and execute translational programs in these areas.
Fibrosis presents across a wide range of clinical conditions, with different phenotypes and endpoints. But they often share a common underlying pathology. This allows for biomarker-driven approaches across specific indications to generate confidence and enable translation.
For NASH, we conceptualized where future opportunities lie, and how this information can be used to inform the design of both preclinical and early clinical studies.
For IPF and other interstitial lung diseases, we have observed how the outlook for patients has been transformed from “Despair to Opportunity” and, with key data emerging from clinical studies with a number of late-stage agents, it will be critical to understand how to profile and develop new assets in a way that is relevant to a future landscape that will be very different to today’s.
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Inflammation is often seen as a precursor and a significant target process in the treatment of fibrotic disease. However, despite the emergence of many new therapies over the last two decades, inflammation remains a significant area of unmet need in its own right.
We are able to identify opportunities for patient stratification and propose designs for preclinical and early clinical studies that mitigate the risks to programs and deliver differentiated molecules in this crowded area.
Orphan and Niche Indications
These indications have considerable overlap with fibrotic and inflammatory conditions but can present additional challenges. These include disease understanding, lack of preclinical models, and a complex clinical and regulatory environment. The latter is driven, in part, by low patient numbers.
The TherapeutAix network has a proven track record in combining clinical data, patient engagement, and key opinion leader feedback to build a comprehensive disease understanding. By considering this in developing disease-relevant and decision-making preclinical assays, we build proprietary knowledge and truly differentiated programs.
Other Therapy Areas
We believe that drug development is an art in and of itself. We have worked extensively in many areas in addition to these described above. The success factors are the same: a thorough understanding of the biology, a strong PK/PD relationship, early differentiation and a clear translational trajectory with defined decision points. Our process allows mapping these principles to many and diverse R&D projects, increasing confidence and building value.