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

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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 December 01, 2020

            Details:

            Xolair (omalizumab) has been approved as an add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older, who have not responded well to nasal corticosteroids.

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            Lead Product(s): Dexamethasone

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

            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 November 30, 2020

            Details:

            FDA’s review of the OTIVIDEX statistical analysis plan confirms use of the Negative Binomial model for analysis of the primary endpoint in the ongoing Phase 3 clinical trial in Ménière’s disease.

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            Lead Product(s): Mometasone Furoate,Azelastine Hydrochloride

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Momat Rino Advance

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Dr. Reddy's Laboratories

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Divestment November 28, 2020

            Details:

            The divested brand and its extensions represent two types of products, (a) Mometasone mono product and (b) combination of Mometasone with Azelastine, and are indicated for the treatment of Seasonal and Perennial Allergic Rhinitis.

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            Lead Product(s): DB-OTO

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: OrbiMed

            Deal Size: $82.0 million Upfront Cash: Undisclosed

            Deal Type: Series D Financing November 09, 2020

            Details:

            DB-OTO, Decibel’s investigational gene therapy to restore hearing in children with congenital deafness due to a deficiency in the otoferlin gene, is in preclinical studies, and Decibel expects to initiate clinical testing in 2022.

            University of Florida

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            Lead Product(s): DB-OTO

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Decibel Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement November 02, 2020

            Details:

            Decibel Therapeutics collaborate with University of California, San Francisco (UCSF) for an adeno-associated virus (AAV) gene therapy technology designed to restore hearing to individuals with profound, congenital hearing loss caused by mutations in the otoferlin gene.

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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): 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.