“We are very pleased with the EMA’s decision to grant OXC-201 ODD for IPF. This is an important milestone that underscores the significant medical need for new drugs for IPF patients and the unique approach of OXC-201,″ says Oxcia’s CEO Ulrika Warpman Berglund. The ODD will be a great support in the soon to start clinical studies and future commercialization.

OXC-201

OXC-201 is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a serious and progressive disease with lung tissue becoming thick and stiff. Over time permanent scarring in the lung, called fibrosis, happens and this makes it difficult to breathe and supply the rest of the body with oxygen. Median survival is presently only 3-5 years.

Preclinical studies show that OXC-201 affects both inflammatory and fibrotic disease markers, resulting in clear tissue-level effects and importantly improved lung function—outcomes that current treatments fail to achieve. Early data indicate that OXC-201 has the potential to reduce coughing, one of the most troublesome symptoms. Data also suggest that OXC-201 is well-tolerated, indicating a potential to significantly improve treatment and quality of life for patients. Clinical trials are due to start in 2027.