Phase 1 Study of EP395 Completed; Phase 2 Trial Planned for This Year

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A first-in-human clinical trial testing the safety and tolerability of EP395, EpiEndo Pharmaceuticals’ experimental treatment for chronic obstructive pulmonary disease (COPD), is now finished.

EpiEndo is planning to launch a Phase 2a trial testing EP395 in people with COPD later this year.

“The successful completion of this study brings us a step closer to addressing the global burden of COPD and other airway diseases by restoring and preserving epithelial integrity and reducing inflammation without the issue of potential anti-microbial resistance,” Ginny Norris, chief medical officer of EpiEndo, said in a press release.

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EP395 is a macrolide — a class of molecules that contain a characteristic structural feature, called a macrocyclic lactone ring. Most macrolides are antibiotics that are designed to kill bacteria. EP395 is part of a novel class of nonantibiotic macrolides being developed by EpiEndo, which the company has dubbed “Barriolides.”

According to EpiEndo, EP395 has anti-inflammatory properties and may help promote the integrity of the epithelial layer that lines the surface of the lung airways. This layer helps protect the lungs from damage. Reduced epithelial integrity has been implicated in COPD and other inflammatory diseases.

The Phase 1 trial (NCT04819854), sponsored by EpiEndo, enrolled 78 healthy volunteers, who were given a single dose of EP395, or multiple doses taken daily for up to 28 days.

According to EpiEndo, results showed the experimental treatment was generally well tolerated, and its pharmacological profile was consistent with once-daily dosing.

“This First Time in Human study provides key clinical insights which highlight the potential for this new class of therapeutic — an encouraging step towards a new treatment for COPD,” said principal trial investigator Dave Singh, MD, who is also a professor at the University of Manchester.

EpiEndo is now planning to launch a Phase 1b clinical trial to further test the pharmacological properties of EP395 in healthy volunteers. The company also plans to start a Phase 2a study that will assess the safety and tolerability of EP395 in people with COPD. The Phase 2a study will also evaluate the treatment’s effect on inflammation biomarkers.

Both trials are expected to start this year, with top-line results anticipated in 2023.

“We are now planning the next stage of clinical development for EP395 and look forward to initiating 2 clinical studies later this year including the first study with EP395 in COPD patients,” Norris said.