EXO Biologics hopes to receive conditional market approval from the European Medicines Agency (EMA) for EXOB-001, a drug for the prevention of bronchopulmonary dysplasia (BPD) in preterm infants, if the Phase I/II trial is successful. .
Hugues Wallemacq, CEO of Belgium-based Biotech, said the company has started a Phase I/II trial in Europe for its mesenchymal stem cell (MSC)-based exosome drug EXOB-001. Stated. Wallemacq said EVENEW is the first European Medicines Agency (EMA)-approved clinical trial targeting MSC-based exosomes.
The trial will be funded thanks to €16 million ($17.1 million) raised through Series A funding. EXO Biologics will also use the funding to support future clinical trials and continue to expand manufacturing of his ExoXpert.
A Phase I/II trial will investigate the candidate as a preventive agent for bronchopulmonary dysplasia (BPD) in preterm infants.
The Phase I portion of the EVENEW trial (NCT06279741) will enroll 36 infants across three cohorts of low, intermediate, and high doses of EXOB-001. The trial will be managed using historical data from babies born at the same location and is expected to use more than 100 babies as artificial placebos. Phase I data is expected in 2025.
Phase II includes three cohorts, two treatment groups, and a placebo group. Wallemacq said that because of the high unmet medical needs of these patients, the company hopes to receive accelerated U.S. Food and Drug Administration (FDA) approval in 2028 if the Phase I/II trial shows positive results. He said he hoped to receive conditional marketing approval from the EMA.
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If approved, the company plans to conduct confirmatory Phase III trials over several years.
Currently, EXO Biologics plans to conduct the trial at facilities in Italy and Belgium, but may also consider conducting the trial at more facilities across Europe.
EXO Biologics has also developed EXO Pulse, a manufacturing platform designed for GMP production of exosomes. This platform enabled the company to launch its subsidiary ExoXpert, a CDMO that develops exosome-based medicines for EXO Biologics and other companies. The Series A financing will also be used to increase the production capacity of the manufacturing facility.
BPD landscape
BPD is a rare respiratory disease that affects premature infants and is associated with significant morbidity and mortality. Currently, there are no drugs approved for the treatment of borderline personality disorder worldwide.
Another drug candidate in development is Advent Therapeutics' lung-targeted inhalation therapy, which delivers aerosolized vitamin A directly to the lungs.
