OXC-201 has secured Orphan Drug Designation from European Medicines Agency

Oxcia welcomes the European Medicines agency’s (EMA) decision to grant Orphan Drug Designation (ODD) for OXC-201 for idiopathic pulmonary fibrosis (IPF).

An ODD from the European Medicines Agency (EMA) is very valuable. It contains critical regulatory and financial incentives designed to encourage pharmaceutical companies to develop therapies for rare diseases with large unmet medical need. The primary advantages include 10 years of market exclusivity, scientific advice, help to design high-quality clinical trials, substantial fee reductions and access to Centralized Authorization Procedure. Importantly it also increases eligibility for grants and accelerated regulatory pathways.

“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 has potential to revolutionize the treatment for IPF

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.

For more information contact:

Ulrika Warpman Berglund, CEO, Oxcia AB (publ)

Telephone: +46 (0) 73 270 9605
ulrika.warpmanberglund@oxcia.com

About Oxcia

Oxcia AB is a clinical-stage biotech company pioneering therapies that target key drivers of many diseases, using its proprietary O2-DDR platform (Oxidative stress, Oxidative DNA damage, and DNA Damage Response (DDR)). The platform has so far generated two first-in-class drug candidates: OXC-101, currently in clinical development for acute myeloid leukemia with both FDA and EMA Orphan Drug Designations, and OXC-201, a novel treatment for idiopathic pulmonary fibrosis supported by European Innovation Council funding. By addressing major unmet medical needs through a differentiated scientific approach, Oxcia aims to deliver transformative therapies to make life less short, creating significant value for patients and investors.