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Find Drugs for Otolaryngology (Ear, Nose, Throat) in Phase II Clinical Development

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            Lead Product(s): FX-322

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 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.

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            Lead Product(s): CYR-064

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: CYR-064

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Remiges Ventures

            Deal Size: $12.8 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing December 10, 2020

            Details:

            The funds will be used to complete a Phase 2 clinical trial of the company’s lead product, CYR-064, in the U.S. and Europe. As part of the financing, Taka Koda of Remiges Ventures and Gerry Brunk of Lumira Ventures have joined the company’s board of directors.

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            Lead Product(s): FX-322

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 29, 2020

            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.

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            Lead Product(s): Betahistine Dihydrochloride

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AM-125

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 13, 2020

            Details:

            First patient has been randomized in Part B of its “TRAVERS” Phase 2 trial of AM-125 (intranasal betahistine) in acute vertigo. This follows the positive read-out from the interim analysis on Part A of the study in early September 2020.

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            Lead Product(s): FX-322

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 22, 2020

            Details:

            FX-322 is Frequency’s lead product candidate for the treatment of acquired SNHL. The Phase 2a study is a randomized, double blind, placebo-controlled, single- and repeat-dose study which enrolled 95 patients, aged 18 to 65, with stable SNHL.

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            Lead Product(s): FX-322

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 13, 2020

            Details:

            New data build upon Phase 1/2 study results showed that for the first time, statistically significant improvements in word recognition (WR) scores in patients with chronic moderate to moderately severe SNHL.

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            Lead Product(s): Mometasone Furoate

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: LYR-210

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            Company will make presentations related to its lead product candidate, LYR-210, at the 66th Annual Meeting of the American Rhinologic Society (ARS), taking place as a virtual event.

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            Lead Product(s): Betahistine Dihydrochloride

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AM-125

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            Interim analysis of Phase 2 “TRAVERS” trial demonstrated a dose-dependent improvement in balance as well as good safety and tolerability of ascending doses of AM-125.

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            Lead Product(s): Etokimab

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: ANB020

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 2020

            Details:

            Etokimab q4w and q8w treatment arms failed to achieve NPS and SNOT-22 statistical significance over placebo at this week 8 interim analysis.