Frequency Therapeutics Completes Enrollment in Safety Trial for Hearing Restoration Drug Candidate, FX-322
WOBURN, MASSACHUSSETTS – Biotech startup, Frequency Therapeutics, announced this week the completion of enrollment in the single dose safety trial to evaluate FX-322, the company’s leading drug candidate for hearing restoration. The randomized, double-blind, placebo-controlled trial will be assessing the safety of a single dose of FX-322 given by intratympanic administration in adult patients with…
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Decibel Therapeutics Obtains Exclusive License to Develop and Commercialize ORC-13661 from Oricula Therapeutics
BOSTON & SEATTLE — Boston-based biotech firm, Decibel Therapeutics, announced this week that it has obtained “an exclusive, worldwide license to the development and commercialization of ORC-13661” from Oricula Therapeutics for the prevention of hearing loss and balance disorders due to the use of aminoglycoside antibiotics. As part of the agreement with Decibel, Oricula will…
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Auris Medical Receives FDA Guidance for Investigative Drug to Treat Sudden Sensorineural Hearing Loss
ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced today that it has received feedback from a Type C meeting with the U.S. Food and Drug Administration (FDA) related to the development plan and regulatory pathway for AM-111, the company’s investigational treatment for sudden sensorineural hearing loss. The meeting had been conducted at the request of…
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Sensorion to Begin Patient Enrollment for Safety Study of Vertigo Drug, Seliforant
MONTPELLIER, FRANCE — Biotech firm Sensorion announced the initiation of patient enrollment in a Phase 2a study (SENS-111-202) to confirm the absence of certain side effects commonly experienced with meclizine (specifically, anticholinergic side effects like sedation and memory loss) during an evoked vestibular imbalance. SENS-111-202 is a randomized, double-blind, double-dummy, placebo-controlled, cross-over trial in patients designed…
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Frequency Therapeutics Launches US Clinical Trials of Hearing Loss Drug; Akouos Raises $50M for Gene Therapy R&D
Biotech startup, Frequency Therapeutics, announced today that the first patients have been treated in a Phase 1/2 clinical trial to evaluate the company’s investigative compound FX-322, the company’s lead Progenitor Cell Activation (PCA) candidate for hearing restoration. The randomized, double-blind, placebo-controlled trial will assess the safety of FX-322 given by intratympanic administration in adult patients…
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Decibel Therapeutics Snags $55 Million Series C Financing for Hearing Drug Development
BOSTON, MASSACHUSETTS — Biotech startup, Decibel Therapeutics, announced that it has raised $55M in a Series C financing round. According to the announcement, all the existing investors–Third rock Ventures, GV, SR One and Regeneron Pharmaceuticals–participated in the financing round and were joined alongside new investors: Foresite Capital, Bessemer Trust, Schroder Adveq, SCubed Capital, Longevity, and…
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Frequency Therapeutics Receives $2M Grant to Investigate Hearing Restoration for US Military
Biotech startup, Frequency Therapeutics, announced today that it has received a U.S. Department of Defense (DoD) Hearing and Balance Research Award grant. The $2 million dollar, peer-reviewed grant will be used to investigate the company’s unique Progenitor Cell Activation (PCA) approach to hearing restoration for military personnel with service-related hearing loss. Prevention of hearing loss…
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Acousia Therapeutics Receives €10 Million Investment to Advance Pipeline of Preclinical Hearing Loss Drug Candidates
TÜBINGEN, GERMANY — Acousia Therapeutics, a privately held biotech firm developing novel therapies for inner ear disease and pathologies, announced this week the closing of a €10 million (approximately $11.8M USD) Series B financing round to “advance its pipeline of preclinical drug candidates into clinical stage”. According to the announcement, the financing round was led…
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Scientists Regenerate Cochlear Hair Cells in Guinea Pigs Using RNA Injection
The cochlear hair cells of humans and other mammals–unlike some animal species (like birds for example)–cannot be restored after damage. Recent research has indicated, however, that manipulation of signaling pathways could lead to hair cell regeneration. Using a sustained-release formulation of small interfering RNAs (siRNAs) delivered via nanoparticles into the cochlea of noise-injured guinea pigs,…
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USC Scientists Develop Method to Repair Damage to Cochlea
Recent research indicates hearing loss is expected to nearly double in 40 years. This figure includes individuals who suffer from the condition of “hidden hearing loss,” which is generally defined to be damage to the inner ear that leads to difficulty hearing soft voices in the presence of background noise, but an audiogram within the…
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