At Higher Doses, Otonomy's OTO-413 Shows No Clinical Benefit In Hearing Loss
- Otonomy Inc 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.
- These results contrast 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 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 and 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.
- Initial clinical studies have demonstrated that a single intratympanic injection of OTO-413 is well-tolerated and improves hearing function across multiple clinically validated speech-in-noise hearing tests.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.