Otolaryngology (Ear, Nose, Throat) | Phase II Developments

Novus Therapeutics, Inc

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Novus Therapeutics Announces Topline Results of Phase 2a Clinical Trial of OP0201 in Acute Otitis Media

Lead Product(s): Colfosceril Palmitate,Cholesteryl Palmitate

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

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 June 01, 2020

Details:

Although the study did not achieve statistical significance for the primary efficacy endpoints, But the statistical trend were encouraging that favored the OP0201 treatment group with regard to resolution of middle ear effusion.

Frequency Therapeutics

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Frequency Therapeutics Shares Clinical Data From Exploratory Study Confirming Delivery of FX-322 to the Cochlea

Lead Product(s): FX-322

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

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 May 14, 2020

Details:

Study revealed measurable concentrations of FX-322 in every patient and that anatomical factors did not prevent the active agents of FX-322 from reaching the cochlea. The levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment.

Lyra Therapeutics

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Lyra Therapeutics wants a $58M IPO

Lead Product(s): Mometasone Furoate

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

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $58.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 09, 2020

Details:

The money will all go toward its ENT meds, which include LYR-210, a miniaturized, bioresorbable device that is implanted deep in the nasal passages.

Novus Therapeutics, Inc

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Novus Therapeutics Completes Enrollment of Phase 2a Trial of OP0201 in Pediatric Patients with Acute Otitis Media

Lead Product(s): Colfosceril Palmitate,Cholesteryl Palmitate

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

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 March 02, 2020

Details:

Study is assessing the safety, tolerability, and efficacy of 20 mg/day intranasal OP0201 as an adjunct therapy to oral antibiotic treatment of acute otitis media in infants and 6 to 24 months olds.

Sensorion

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Sensorion gets approval to add new sites to Phase II trial of SENS-401

Lead Product(s): Azasetron

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

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 18, 2020

Details:

Named AUDIBLE-S, the Phase II trial is being conducted to evaluate a 43.5mg and 29mg twice-daily dose of SENS-401 for four weeks in patients suffering from severe or profound SSNHL.

Sensorion

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Sensorion Receives Ethics Committee Approval to Include New Military Sites in SENS-401 Phase 2 study

Lead Product(s): Azasetron

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

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 17, 2020

Details:

The new centers will recruit volunteer military personnel exposed to impulse noise during their professional activities and suffering from hearing loss.

Auditus

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Oblato Biotech Company Acquires Hearing Loss Drug

Lead Product(s): N-Acetylcysteine,2,4-disulfonyl alpha-phenyl tertiary butyl nitrone

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

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Oblato

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement February 12, 2020

Details:

Oblato assumes exclusive rights to a drug known as NHPN-1010. Oblato is expected to initiate a phase 2 clinical trial to evaluate the potential of the drug to prevent and treat hearing loss.

Sensorion

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Sensorion Presents New SENS-401 Preclinical Data at ARO Midwinter Meeting 2020

Lead Product(s): Azasetron

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

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 January 30, 2020

Details:

SENS-401 significantly reduces ABR wave 1 amplitude loss after chronic noise exposure in a rat model.

Lyra Therapeutics

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Lyra Therapeutics Announces FDA Clearance of Investigational New Drug Application for a Phase 2 Clinical Trial of LYR-210 for Chronic Rhinos...

Lead Product(s): Mometasone Furoate

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

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 January 06, 2020

Details:

Lyra plans to incorporate U.S. clinical sites into LANTERN, its ongoing global Phase 2 clinical trial of LYR-210, which was initiated in May 2019 at sites in New Zealand, Australia and Europe.

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Novus Therapeutics, Inc

Novus Therapeutics Announces Topline Results of Phase 2a Clinical Trial of OP0201 in Acute Otitis Media

Frequency Therapeutics

Frequency Therapeutics Shares Clinical Data From Exploratory Study Confirming Delivery of FX-322 to the Cochlea

Lyra Therapeutics

Lyra Therapeutics wants a $58M IPO

Novus Therapeutics, Inc

Novus Therapeutics Completes Enrollment of Phase 2a Trial of OP0201 in Pediatric Patients with Acute Otitis Media

Sensorion

Sensorion gets approval to add new sites to Phase II trial of SENS-401

Sensorion

Sensorion Receives Ethics Committee Approval to Include New Military Sites in SENS-401 Phase 2 study

Auditus

Oblato Biotech Company Acquires Hearing Loss Drug

Sensorion

Sensorion Presents New SENS-401 Preclinical Data at ARO Midwinter Meeting 2020

Lyra Therapeutics

Lyra Therapeutics Announces FDA Clearance of Investigational New Drug Application for a Phase 2 Clinical Trial of LYR-210 for Chronic Rhinos...