Otonomy Reports Corporate and Product Pipeline Update – Yahoo Finance

Multiple clinical trial readouts for OTO-313 in tinnitus and OTO-413 in hearing loss expected during 2022

Current capital funds operations into second half of 2023

SAN DIEGO, Jan. 06, 2022 (GLOBE NEWSWIRE) — Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and financial guidance. Consistent with previously stated timing, the company expects to report results for the Phase 2a cohort of OTO-413 in hearing loss patients early in the second quarter of 2022 and the Phase 2 trial of OTO-313 in tinnitus patients in mid-2022. The company also plans to initiate a clinical safety evaluation of higher unilateral as well as bilateral dosing of OTO-313 and, as previously announced, has initiated clinical evaluation of higher dosing of OTO-413. Results of these multiple studies are expected to inform initiation of a full dose-ranging Phase 2 trial for OTO-413 by the end of 2022 and start of the Phase 3 clinical program for OTO-313 in the first half of 2023.

The company finished 2021 with approximately $77 million in cash, cash equivalents and short term investments and expects that its current capital is sufficient to fund operations into the second half of 2023.

“We are excited to begin 2022, a catalyst-rich year for Otonomy because of our multiple clinical trial readouts for both OTO-313 and OTO-413, novel products that target large patient populations with high disease burden and no approved drug treatment,” said David A. Weber, Ph.D., president and CEO of Otonomy. “For OTO-313, we expect to generate robust clinical data to inform the Phase 3 program by having efficacy readouts for Months 1 and 2 as well as the extended follow-up period out to Month 4, and we will also have safety data for both a higher unilateral OTO-313 dose and bilateral dosing. Similarly, efficacy data from the OTO-413 Phase 2a cohort plus ongoing dose escalation evaluation will provide a good basis for initiating a full dose-ranging Phase 2 efficacy trial for OTO-413 later this year.”

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Product Pipeline Update

• OTO-313: Phase 2 trial in tinnitus is ongoing with top-line results expected in mid-2022; initiating safety evaluation of higher and bilateral dosing. Otonomy is conducting a Phase 2 trial of OTO-313 that will enroll approximately 140 patients with persistent, unilateral tinnitus of at least moderate severity. Patients are being randomized 1:1 to a single intratympanic injection of OTO-313 (0.32 mg) or placebo. The primary endpoint is the same as reported for the successful Phase 1/2 trial: a responder analysis based on the proportion of patients who report a clinically meaningful improvement in the Tinnitus Functional Index (TFI) from baseline to Months 1 and 2 following treatment. To assess …….

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