Novus Therapeutics Receives FDA Guidance for Phase 2a POP201 Study

Novus Therapeutics (NASDAQ:NVUS) has announced that the US Food and Drug Administration (FDA) has given guidance on the company’s plan for a Phase 2a study of OP0201 in patients with chronic otitis media with effusion (COME).

As quoted in the press release:

The FDA’s feedback on the study C-009 was detailed in the minutes from a Type C meeting held with the Company’s management team on September 20, 2019.

Study C-009 is designed to explore the effect of daily administration of OP0201 in patients with COME, a non-infectious form of otitis media. The study will enroll infants and children with three months or longer of bilateral middle ear effusion and hearing loss. The primary endpoints of study C-009 will be the resolution of middle ear effusion and/or restoration of hearing.

“We are pleased to have alignment with the FDA on our planned Phase 2a chronic otitis media with effusion study,” said Dr. Catherine C. Turkel, President of Novus Therapeutics, Inc. “Persistent middle ear effusion and associated hearing loss is problematic, particularly for young patients in their developmental years. To date, no drug product has been approved for the treatment of this condition and surgery to insert tympanostomy tubes to clear the middle ear effusion is the only option for these patients. We look forward to studying OP0201 in this population.”

Click here to read the full press release.