Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, has completed the acquisition of certain assets and rights to intellectual property (IP) related to the use of gacyclidine for the treatment of tinnitus from an affiliate of NeuroSystec Corporation.

Successful serial entrepreneur Alfred Mann founded NeuroSystec to develop a drug-device combination product that could provide sustained delivery of gacyclidine to the inner ear. Gacyclidine is a potent and selective antagonist of the N-Methyl-D-Aspartate (NMDA) receptor. Clinical studies, including pilot studies conducted with gacyclidine, support the use of NMDA antagonists as treatments for tinnitus. The company’s third development programme, OTO-311, utilizes Otonomy’s proprietary drug delivery technology to achieve sustained exposure of gacyclidine in the inner ear from a single intratympanic (IT) injection.

The acquisition provides the company with preclinical, clinical, and manufacturing data produced by NeuroSystec in its development of gacyclidine, which was delivered to the inner ear via a pump and micro-catheter for the treatment of tinnitus. In addition, the company also acquired intellectual property rights including issued and pending patent applications that augment the current patent estate protecting OTO-311.

“Emerging clinical data combined with completion of this transaction help set the stage for a streamlined development path for OTO-311 as a treatment for tinnitus,” said David A Weber, Ph.D., president and CEO of Otonomy. “Furthermore, the addition of this third programme to our product pipeline exemplifies our commitment to broadly address unmet medical need in the treatment of otic disorders.”

"We are pleased to transfer the data and results from our efforts, and IP surrounding gacyclidine to further the development of OTO-311. We believe that prolonged drug exposure to the inner ear is essential for optimal treatment and that Otonomy's technology featuring single injection delivery is a patient friendly innovation," stated Alfred Mann. "OTO-311 has exciting potential to provide relief to the millions of individuals worldwide who suffer from tinnitus."

Tinnitus is the medical term for hearing noises in the ears when there is no outside source of the sounds. It is often described as a ringing in the ears but can also sound like roaring, clicking, hissing or buzzing, and can be soft or loud. An estimated one in five adults may experience tinnitus in one or both ears. While the most common cause of tinnitus is exposure to loud noise, a number of other factors can be involved including heart or blood vessel problems, hormonal changes in women, ear and sinus infections, certain medications and thyroid problems. People with severe tinnitus may have trouble hearing, working or even sleeping. At this time, there is no cure for tinnitus and there are no FDA-approved drugs for treating this debilitating condition.