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Find Clinical Drug Pipelines for Otolaryngology (Ear, Nose, Throat)

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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): Benralizumab,Mometasone Furoate

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

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 10, 2020

            Details:

            Fasenra showed a statistically significant improvement in the endoscopic total nasal polyp score and the nasal blockage score compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite continued treatment with standard of care.

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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): AUT00206

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AUT00206

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Boehringer Ingelheim GmbH

            Deal Size: $50.1 million Upfront Cash: $29.5 million

            Deal Type: Termination August 26, 2020

            Details:

            Boehringer Ingelheim will not be exercising its Option under the Option for Asset Purchase Agreement which was signed by the two companies in December 2017. Autifony has regained full rights to its Kv3 programme.

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            Lead Product(s): Sodium Thiosulfate

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

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 11, 2020

            Details:

            After recent completion of a pre-approval inspection of the manufacturing facility of Fennec's drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of practices that are required to be resolved prior to the approval of PEDMARK™.

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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.

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            Lead Product(s): Omalizumab

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

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 06, 2020

            Details:

            EC approves Xolair® (omalizumab) as an add-on therapy for severe chronic rhinosinusitis with nasal polyps, the first anti-immunoglobulin E antibody approved in this indication.

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