- Higher dose cohorts for OTO-413 demonstrated no clinically meaningful improvement for patients from baseline
- Lack of activity compared to 0.3 mg dose evaluated in prior studies may be due to a complex dose-response relationship that has been observed with neurotrophins
- Otonomy intends to explore strategic options to advance and realize value from its pipeline including both OTO-413 and OTO-825
SAN DIEGO, Oct. 13, 2022 (GLOBE NEWSWIRE) — Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that the clinical evaluation of higher doses for OTO-413 (0.75 mg and 1.50 mg) in patients with hearing loss demonstrated no clinically meaningful improvement for patients from baseline across multiple speech-in-noise (SIN) hearing tests. These results are in contrast to the positive clinical signal observed with 0.3 mg OTO-413 versus placebo in the previous Phase 1/2 and Phase 2a trial cohorts using the same study design and endpoints.
The randomized, double-blind, placebo-controlled higher dose cohorts enrolled patients who self-reported difficulty hearing in a noisy environment that was confirmed with a SIN hearing test. In each dose cohort, nineteen patients were randomized 2:1 to a single intratympanic injection of OTO-413 (0.75 mg or 1.50 mg) or placebo. Patients were assessed with the same SIN tests utilized in prior cohorts including the Words-in-Noise (WIN) test, with the assessment of treatment benefit based on demonstration of a clinically meaningful improvement from baseline versus placebo at both Days 57 and 85.
“The lack of clinical activity for OTO-413 in these higher dose cohorts is disappointing and unexpected based on our in vivo preclinical studies which supported a broad therapeutic dose range for OTO-413. However, our ex vivo studies as well as data in the neurotrophin literature suggest the possibility of a complex dose-response relationship for BDNF with declining activity observed at higher dose levels, which might explain these results,” said Alan C. Foster, Ph.D., chief scientific officer of Otonomy. “We have previously demonstrated in two separate study cohorts that a single, unilateral injection of 0.3 mg OTO-413 provides a clinically meaningful improvement for patients from their baseline hearing level compared to placebo.”
“We have learned a great deal about the various SIN hearing tests, patient profiles, study design considerations and dosing from the multiple clinical trial cohorts we have conducted for OTO-413 which is intended to treat the most common complaint of hearing loss patients,” said David A. Weber, Ph.D., president and CEO of Otonomy. “In light of the challenging financing environment, we intend to explore strategic options to advance and realize value from our pipeline including both OTO-413 and OTO-825, our gene therapy program for congenital hearing loss.”
