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FX-322 is a combination of proprietary small molecules designed to restore hearing function by activating inner ear progenitor cells in the cochlea to induce hair cell regeneration and improve hearing function.
Lead Product(s): FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2023
Details:
FX-345 is a combination of two small molecules and, similar to Frequency’s lead hearing candidate FX-322, is designed to restore inner ear cells needed for hearing.
Lead Product(s): FX-345
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-345
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2022
Details:
FX-322, is a small-molecule combination product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss.
Lead Product(s): FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
FX-322 lead hearing restoration product candidate showed improvement by four subjects in a sentence-in-noise test is designed to regenerate auditory hair cells to restore hearing function.
Lead Product(s): FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2021
Details:
Clinical data review from four completed FX-322 clinical studies, including 169 subjects with a range of hearing loss severities and SNHL etiologies (sudden, noise-induced, age-related).
Lead Product(s): FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2021
Details:
The U.S. Food and Drug Administration (FDA) recently agreed with speech perception as the primary endpoint for FX-322 development, including for the FX-322-208 study and all future FX-322 studies.
Lead Product(s): FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2021
Details:
FX-322 is a thermoreversible poloxamer that is injected intratympanically as a liquid and transitions to a gel used in adults With severe sensorineural hearing loss.
Lead Product(s): FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2021
Details:
Frequency also announced new data from a parallel study demonstrating hearing improvement from a single injection of FX-322. The Company plans to advance further development of FX-322 as a single dose regimen.
Lead Product(s): FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2021
Details:
Findings from the Phase 1/2 study of FX-322, the company’s lead product candidate to treat SNHL, showed statistically significant increases in word recognition (WR) and words-in-noise (WIN) scores.
Lead Product(s): FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
Details:
Frequency is expanding its clinical development program to evaluate FX-322’s clinical profile in other SNHL patient groups, including age-related and severe SNHL patients.
Lead Product(s): FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
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