Novus Therapeutics begins phase 1 trial of OP0201 in otitis media

Novus Therapeutics has launched a phase 1 pharmacodynamics clinical trial for its promising candidate, OP0201, aimed at treating otitis media—a common middle ear infection. The California-based specialty pharmaceutical company, known for its focus on ENT (ear, nose, and throat) disorders, has begun dosing the first adult patients in the trial, named OP0201-C-001, which is taking place in Germany.

What is Otitis media?

Otitis media refers to a group of inflammatory diseases affecting the middle ear, typically triggered by Eustachian tube dysfunction (ETD). The Eustachian tube is a small passage connecting the middle ear to the nasopharynx, and when it does not function properly, it can lead to ear infections. This condition is particularly common in children but can affect adults as well.

OP0201: A breakthrough treatment for otitis media

OP0201 is a drug-device combination therapy designed to treat the underlying cause of otitis media. It combines two key ingredients: dipalmitoylphosphatidylcholine (DPPC), a surfactant, and cholesteryl palmitate (CP), a spreading agent. The product is delivered intranasally via a pressurized metered-dose inhaler (pMDI), a device typically used for inhaling medication. The goal is to restore normal physiological function to the Eustachian tube, which could help in alleviating symptoms of ETD and prevent recurrent ear infections.

Key objectives of the clinical trial

The OP0201-C-001 clinical trial is designed to assess the safety and tolerability of the product, as well as its effectiveness in improving Eustachian tube function in adults. The trial will involve 16 healthy adults who will receive a 20 mg dose of OP0201 and will be monitored for changes in Eustachian tube function through continuous tympanic impedance. This will be done while the participants are exposed to varying atmospheric pressures inside a hyperbaric/hypobaric chamber—a method used to simulate the pressure changes that affect the ear during activities such as air travel or diving.

Dr. Catherine Turkel, President of Novus Therapeutics, commented on the study, stating that while the trial will provide crucial safety data, it also aims to explore the potential effect of OP0201 on Eustachian tube function under pressure variations. She added that they are excited to share the results of the trial later this year.

The successful completion of this trial could mark a significant step forward in treating otitis media, providing a new option for patients suffering from this condition.