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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.
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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 July 29, 2020
Details:
Auris Medical Holding completed patient enrollment into Part A of its Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo (AM-125). The Company expects to release interim results from TRAVERS and commence Part B of the trial in the coming weeks.
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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.
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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.
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