A “near miss” is how San Diego-based Otonomy Inc. (OTIC) describes the results of its Phase IIb clinical trial for OTO-104 for Ménière’s disease.

The company could not be reached for a statement in time for deadline.

The primary endpoint of the trial was decreasing the frequency of vertigo associated with Ménière’s disease in patients receiving OTO-104 in the third month of treatment. In patients receiving the drug, there was a 61 percent reduction from baseline in vertigo frequency compared to 43 percent in patients receiving a placebo.

“While the trial narrowly missed achieving statistical significance on the primary endpoint, we believe the clear efficacy trends observed along with the multiple secondary endpoints where statistical significance was achieved provide a solid basis to move OTO-104 forward into Phase III testing,” said David Weber, president and chief executive officer of Otonomy in a statement. “We plan to request an End-of-Phase II meeting with the FDA and intend to initiate two parallel Phase III trials in Ménière’s disease with the first beginning by the end of 2015.”

The company’s stock dropped 18.7 percent to $10.25 after close yesterday. Otonomy’s stock has been on something of a roller coaster ride the last year. On Aug. 19, 2014, shares sold for $15.84. They rose significantly to an all-time high of $40.00 on Dec. 16, 2014, dropped for a few months, then rose a bit on April 29, 2015 to $26.98. On May 19 shares sold for $33.04. They currently are selling at $23.67.

The company has a provocative narrative. In 2008, Jay Lichter, a partner at Avalon Ventures, had an intense attack of vertigo, which resulted in a diagnosis of Ménière’s disease. In response, he founded Otology with Jeffrey Harris, chief of the division of otolaryngology—head and neck surgery at the University of California, San Diego (UCSD) with several others.

In addition to OTO-104, the company has other products in its developmental pipeline. AuriPro is involved in a registration trial as a middle ear effusion at the time of TTP surgery, and OTO-311 is in preclinical development for the treatment of tinnitus. On May 7 the company announced that it had completed enrollment in its Phase II trial for AuriPro, which is a sustained-exposure formulation of the antibiotic ciprofloxacin for pediatric patients with acute otitis media with tympanostomy tubes (AOMT).

“We are very encouraged by the initial results of this trial which support the feasibility of administering AuriPro to fully alert children in a physician’s office setting,” said Weber in a statement. “The rapid enrollment also demonstrates physician and caregiver interest in a product that can potentially provide a full course of antibiotic treatment in one ENT-administered dose.” A conference call and webcast will be held today at 4:30 p.m. EDT/1:30 p.m.

May 22, 2015
By Mark Terry, BioSpace.com Breaking News Staff