FDA grants fast-track eligibility for FX-322 fast-track, a research candidate drug for hearing recovery

Today, FrequencY Therapeutics Biotechnology(http:// announcedthat its research candidatedrug(http://FX-322 has been granted fast-track eligibility by the
FDA(http://The drug also achieved the first patient administration in phase 2a of treatment for sensorineural hearing lossAbout FX-322
small molecular drug mixture FX-322, is designed to promote the growth of hair cells through progenitor cell activation (progenitor cell activation, PCA), and ultimately achieve the goal of reversing biological defects and restoring theof healthy(http:// of tissueTHE FX-322 IS PRESCRIBED BY PASSING THROUGH THE EARDRUM THROUGH A NEEDLE FOR 10 TO 15 MINUTES, SIMILAR TO ROUTINE SURGERY PERFORMED BY AN OTOLARYNGOLOGIST AT THE CLINICFX-322 is liquid at room temperature, but becomes a gel at body temperature, and its formulation allows the active ingredient of the compound to spread throughout the inner ear 　　The results of the completed phase 1/2 of the experiments showed that FX-322 had statistically significant and clinically significant improvements in hearing functions, such as word recognition and sound clarity 　　The 2a phase trial (http:// will recruit about 96 SNHL patients for a total of four injections per week 　　The main therapeutic endpoints of the trial were word recognition (WR), word recognition (WIN) in noise, and standard pure sound listening, and the end point of exploratory efficacy was extended high-frequency pure audio- and tinnitus-function index (TFI) and adult hearing impairment list (HHIA)