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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Otonomy Inc | NASDAQ:OTIC | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.077 | 0.0757 | 0.0777 | 0 | 01:00:00 |
Analysis of Patients Enrolled through Month 3 (n = 111) | p value |
Count of DVD by Poisson Regression Analysis | 0.014 |
Mean Vertigo Severity Score | 0.030 |
Change in Vertigo Frequency from Baseline | 0.030 |
Numbers of Days Sick at Home or Bedridden | 0.042 |
The clinically significant treatment benefit demonstrated by OTIVIDEX versus placebo in AVERTS-2 was consistent with expectations from the Phase 2b trial. Based on completion of data review, the AVERTS-1 trial failed due to a significantly higher placebo response and was not attributable to a difference in patient demographics or baseline characteristics compared to AVERTS-2. A review of the AVERTS trials including consultation with outside experts suggests that the higher placebo response was primarily due to increased expectation bias in the U.S. trial. Otonomy has requested a Type C meeting with the U.S. Food and Drug Administration (FDA) and expects to meet during the first quarter of 2018 to review the AVERTS results and any remaining clinical requirements for registration of OTIVIDEX in Ménière’s disease. The company expects that any remaining clinical development required for registration will be initiated in mid-2018.
"We are excited to begin 2018 given our broad product pipeline targeting important unmet medical needs and large patient populations in otology, and our strong balance sheet to support its development," said David A. Weber, Ph.D., president and CEO of Otonomy. "Results of the successful AVERTS-2 trial clearly demonstrate that OTIVIDEX provides a significant clinical benefit for patients with Ménière’s disease, and our advancement of multiple programs for hearing loss and continued development of gacyclidine for tinnitus together illustrate our commitment to developing innovative treatments for this emerging field."
1Tremblay et al., Ear Hear (2015)2Goman and Lin, Am J Public Health (2016)
About OtonomyOtonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for diseases and disorders of the ear. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, plans to meet with the FDA regarding the clinical development requirements for OTIVIDEX™ and the timing of any such meeting, timing of any remaining OTIVIDEX clinical work required, timing of IND filing and Phase 1/2 clinical trial for OTO-413, timing of Phase 1/2 clinical trial for OTO-313, financial guidance for 2018, timing of candidate selection for OTO-5XX and OTO-6XX programs, ability to fund completion of OTIVIDEX clinical development, and the ability of Otonomy to complete a divestiture of OTIPRIO®, and statements by Otonomy’s president and CEO. Otonomy's expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy's product candidates; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of its product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 8, 2017, and Otonomy's future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.
Contacts:
Media InquiriesCanale CommunicationsHeidi Chokeir, Ph.D.Senior Vice President619.849.5377heidi@canalecomm.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging Director858.356.5932robert.uhl@westwicke.com
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