Frequency Therapeutics (Nasdaq:FREQ) shares were down more than 80% on Monday afternoon after the company announced the failure of the Phase 2b study for FX-322, its lead candidate drug for hearing loss. As a result, the Lexington, Massachusetts-based biotech company will discontinue its hearing loss program and cut its workforce by 55%. It says its…
Otonomy gives up on experimental tinnitus drug after disappointing Phase 2 trial
Neurotology-focused biopharma Otonomy (Nasdaq:OTIC) will cease development of OTO-313 after the experimental drug failed to show clinically meaningful benefit in a randomized, placebo-controlled Phase 2 trial. The company’s lead asset, OTO-313, did not meet either primary or secondary endpoints in the study, which involved 152 patients with persistent, unilateral tinnitus of at least moderate severity.…
Pfizer to Acquire ReViral and Its Respiratory Syncytial Virus Therapeutic Candidates
Pfizer (NYSE:PFE) announced today that it entered into an agreement to acquire biopharmaceutical company ReViral. ReViral discovers, develops and commercializes novel antiviral therapeutics designed to target respiratory syncytial virus (RSV). “At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine…
Decibel Therapeutics touts progress with lead gene therapy product candidate DB-OTO
Decibel Therapeutics (NSDQ:DBTX) recently presented preclinical data for DB-OTO at the Annual MidWinter Meeting of the Association for Research in Otolaryngology (ARO). DB-OTO is a dual-vector adeno-associated virus (AAV) investigational gene therapy product candidate for individuals with hearing loss from mutations of the otoferlin gene. The most recent data showed that otoferlin expression increased for…
Investigational tinnitus drug shows promise in Phase 1/2 study
Neurotology drug developer Otonomy (NSDQ:OTIC) has announced that its OTO-313 drug appeared to reduce tinnitus severity in some participants in a small study. In the study, summarized in Otology & Neurotology, patients with moderate to severe unilateral tinnitus received intratympanic administration of the drug or placebo. Six OTO-313 recipients out of 14 (43%) showed a meaningful…
Decibel Therapeutics announces study on noise-related inner ear damage
Decibel Therapeutics (NSDQ:DBTX) has a working hypothesis that molecular characterization of the cell biology of the inner ear could pave the way for treatments for hearing and balance disorders. The Boston-based biotech company has announced that a recent study published in Cell Reports supports that hypothesis. “We were thrilled to leverage our data and expertise in inner…
Man experiences facial palsy twice after receiving both COVID-19 vaccine doses
The possibility of mRNA causing facial palsy continues to make headlines. A month after a JAMA study found no link between the Pfizer-BioNTech vaccine and facial paralysis, an article in BMJ Case Reports describes the case of a 61-year-old U.K. man who experienced facial palsy episodes after receiving both doses of the Pfizer-BioNTech vaccine. The journal reports that…
Frequency Therapeutics faces growing legal challenges
Hearing loss drug developer Frequency Therapeutics (NASDAQ: FREQ) is the subject of a growing number of security fraud accusations on behalf of investors. Earlier this year, things were looking up for the company’s lead product candidate, FX-322. But on March 23, Frequency Therapeutics announced that interim results suggested that FX-322 was not effective at improving…
Otonomy expands Phase 1/2 hearing loss clinical trial
Neurotology drug developer Otonomy (NSDQ:OTIC) is expanding a Phase 1/2 trial of OTO-413 in patients with difficulty with speech-in-noise tests. In the trial, clinical investigators administer the drug as a single intratympanic injection. The company said that OTO-413 showed promise in improving hearing in a dose escalation efficacy cohort. The randomized, double-blind, placebo-controlled Phase 1/2…