EXO Biologics is developing EXOB-001 for preterm newborns to prevent bronchopulmonary dysplasia. Image credit: Iryna Inshyna / Shutterstock

EXO Biologics is hoping to receive conditional market approval from the European Medicines Agency (EMA) for its bronchopulmonary dysplasia (BPD) preventative EXOB-001 in preterm newborns if the Phase I/II trial is successful.

CEO Hugues Wallemacq of the Belgium-based biotech said that the company has initiated its Phase I/II trial of mesenchymal stem cells (MSC)-based exosome drug EXOB-001 in Europe. Wallemacq said that EVENEW is the first European Medicines Agency (EMA) authorised clinical trial involving MSC-based exosomes.

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The trial will be funded thanks to €16m ($17.1m) gained through Series A funding. EXO Biologics will also use the funds to support future clinical trials as well as continuing its manufacturing expansion, ExoXpert.

 The Phase I/II trial will investigate the candidate as a preventative to Bronchopulmonary Dysplasia (BPD) in preterm newborns.  

The Phase I portion of the EVENEW trial (NCT06279741) will enroll 36 babies across three cohorts, a low dose, medium hose and high dose of EXOB-001. The trial will be controlled using historical data from babies born at the same site, with hopes to use more than 100 babies as an artificial placebo. Data from the Phase I stage is expected in 2025.

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Phase II will include three cohorts, two treatment groups and a placebo group. Wallemacq said that due to the high unmet medical needs of these patients, the company hopes that a positive Phase I/II trial could lead to accelerated approval from the US Food and Drug Administration (FDA) and conditional marketing approval from the EMA in 2028.

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If approval is granted, the company will then run a confirmatory Phase III trial taking place over several years.

Currently, EXO Biologics will be running the trial at sites in Italy and Belgium but may look to run the study at more sites across Europe.

EXO Biologics has also developed a manufacturing platform EXO Pulse designed for GMP production of exosomes. This platform has allowed the company to launch a subsidiary company, ExoXpert, a CDMO to develop exosome-based drugs for EXO Biologics and other companies. The Series A financing will also be used to increase the capacity manufacturing facility.

BPD landscape

BPD is a rare respiratory disorder that affects premature babies resulting in significant morbidity and mortality. Currently, there are no approved drugs worldwide for the treatment of BPD.

Another drug candidate in development is Advent Therapeutics lung-targeted inhalation therapy that delivers aerosolised vitamin A directly to the lung.