A Phase 2 Double Blind, Randomized, Placebo Controlled Trial inVEstigating the Effect and Safety of Several Dosing Regimens of LY3056480 in Patients With STAble Sensorineural Hearing Loss

A phase 2 trial with LY3056480 in patients with stable SNHL

开始日期2022-09-01

申办/合作机构

Audion Therapeutics BV

EUCTR2016-004544-10-GR / Not yet recruiting临床2期

A phase I/II multiple ascending dose open-label safety and efficacy study of the Notch Inhibitor LY3056480 in patients with mild to moderate sensorineural hearing loss. - REGAIN

开始日期2019-01-25

申办/合作机构

Audion Therapeutics BV

EUCTR2016-004544-10-GB / Unknown status临床2期

A phase I/II multiple ascending dose open-label safety and efficacy study of the Notch Inhibitor LY3056480 in patients with mild to moderate sensorineural hearing loss. - REGAIN

开始日期2017-09-18

申办/合作机构

Audion Therapeutics BV

100 项与 LY-3056480 相关的临床结果

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100 项与 LY-3056480 相关的转化医学

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100 项与 LY-3056480 相关的专利（医药）

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项与 LY-3056480 相关的文献（医药）

Nature Communications1区 · 综合性期刊

A phase I/IIa safety and efficacy trial of intratympanic gamma-secretase inhibitor as a regenerative drug treatment for sensorineural hearing loss

1区 · 综合性期刊

ArticleOA

作者: Dalhoff, Ernst ; Wolpert, Stephan ; Khalil, Sherif ; Bibas, Athanasios ; Kikidis, Dimitris ; Schilder, Anne ; Lowenheim, Hubert ; Rutten, Rolf Jan ; Blackshaw, Helen ; Cooper, Hannah ; Schilder, Anne G. M. ; Mueller, Marcus ; Bilhet, Asger ; Iliadou, Eleftheria ; Bibas, Athanasios G. ; Markatos, Nikos ; Edge, Albert S. B. ; Edge, Albert ; Wilke, August ; Schneider, Fritz ; Schade-Mann, Thore ; Arram, Elizabeth ; van Diggelen, Femke ; Pastiadis, Kostas ; Hojgaard, Karin ; Middelink, Leonie ; Saeed, Shakeel ; van Es, Helmuth ; Middelink, Leonie M. ; Yildirim, Omursen ; Vardonikolaki, Katerina

AbstractInhibition of Notch signalling with a gamma-secretase inhibitor (GSI) induces mammalian hair cell regeneration and partial hearing restoration. In this proof-of-concept Phase I/IIa multiple-ascending dose open-label trial (ISRCTN59733689), adults with mild-moderate sensorineural hearing loss received 3 intratympanic injections of GSI LY3056480, in 1 ear over 2 weeks. Phase I primary outcome was safety and tolerability. Phase lla primary outcome was change from baseline to 12 weeks in average pure-tone air conduction threshold across 2,4,8 kHz. Secondary outcomes included this outcome at 6 weeks and change from baseline to 6 and 12 weeks in pure-tone thresholds at individual frequencies, speech reception thresholds (SRTs), Distortion Product Otoacoustic Emissions (DPOAE) amplitudes, Signal to Noise Ratios (SNRs) and distribution of categories normal, present-abnormal, absent and Hearing Handicap Inventory for Adults/Elderly (HHIA/E). In Phase I (N = 15, 1 site) there were no severe nor serious adverse events. In Phase IIa (N = 44, 3 sites) the average pure-tone threshold across 2,4,8 kHz did not change from baseline to 6 and 12 weeks (estimated change −0.87 dB; 95% CI −2.37 to 0.63; P = 0.252 and −0.46 dB; 95% CI −1.94 to 1.03; P = 0.545, respectively), nor did the means of secondary measures. DPOAE amplitudes, SNRs and distribution of categories did not change from baseline to 6 and 12 weeks, nor did SRTs and HHIA/E scores. Intratympanic delivery of LY3056480 is safe and well-tolerated; the trial’s primary endpoint was not met.

100 项与 LY-3056480 相关的药物交易

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