After the first year, Oxcia has obtained additional new data supporting the potential of OXC-201 as a novel IPF therapy. In disease models, OXC-201 has shown significant reduction in inflammation- and fibrotic markers important for the IPF development, suggesting that this drug candidate can hinder the progress of the disease. This has been validated in human IPF lung tissue, in so called ex vivo studies, where lung tissue from IPF patients is treated with the drug candidate. OXC-201 is shown to be more effective compared to standard of care, supporting the ground-breaking potential of this new treatment. Furthermore, preliminary data demonstrates improvement of the lung function with OXC-201 treatment in the disease models, something that will be further studied in the next coming months. The initial pre-clinical safety assessments have also been initiated. So far, OXC-201 seems to be well tolerated.

OXC-201 has the potential to radically change and grow the IPF market. It has potential to halt the disease, improve lung function, improve survival and be safe and tolerable. It has potential to protect lung tissue and repair lung tissue, thereby possibly turning IPF to a chronic disease rather than a deadly disease.

The pre-clinical work in WP1 has during the first 12 months, delivered data that confirms the promising profile of OXC-201. Patent applications of the new chemical entity have been approved in Japan, China and US – countries with high number of IPF patients. The European application is under evaluation.

The IPF market has grown, there is a lot of untreated patients due to the limitations of current treatments and the interest from big pharma and biotech is currently very high with a lot of acquisition and licensing activities and high deal values.   

The market research done in the program has confirmed that the two approved therapies for IPF have severe limitations and that the unmet medical need is enormous. Costs are also very high.

Lung transplantation improves survival but is open only to some patients. Selection of patients is based on certain criterias: high risk of death (>50 %) in the following two years without transplantation, reasonably good physical condition, high probability of survival 90 days after intervention (>80 %) and high probability of surviving five years after the transplant (>80 %). For example, patients > 65 or with severe morbidities are all excluded from the transplantation waiting lists

OXC-201 has potential to provide important economic and societal benefits.

The foremost effect of TOPFIBRO will be accelerating the development of an urgently needed treatment for IPF. IPF is considered a terminal diagnosis and low survival rate of 3-5 years post diagnosis. Shortness of breath and severe cough, further decrease quality of life and overall capabilities of the patient. OXC-201 would be the first potentially curative therapy for IPF, thereby significantly improving quality and length of life compared with current standard of care treatment. There will also be other positive impacts following the project, for patients in the selected additional indications and regarding employment when Oxcia significantly gears up resource wise for further clinical development. Inhibition of OGG1 is a novel ground-breaking approach for treatment of inflammatory and fibrotic diseases. Reported data and future research not only open up for potential new treatment of several indications with high unmet medical need, but also contribute to a better understanding of the pathology of inflammatory and fibrotic diseases by accumulating scientific knowledge

Oxcias goal is to demonstrate health economic value with OXC-201. Today the cost burden is very high both for Health payers and patients, who are today not always able to afford treatment. As OXC-201 significantly improves lung function and survival and has very good tolerability, quality of life will increase and mean higher Quality Associated Life Years (QALYs) compared to current standard of care.