Business
Frequency Therapeutics Provides Business Updates and Second Quarter 2021 Financial Results
Company Plans to Commence New FX-322 Phase 2 Study in Q4 2021 in a Refined Population of Individuals with Sensorineural Hearing Loss (SNHL) Will Host R&D
About this update from Korro Bio, Inc.
[{"type":"text","content":"\nCompany Plans to Commence New FX-322 Phase 2 Study in Q4 2021 in a Refined Population of Individuals with Sensorineural Hearing Loss (SNHL)\n\nWill Host R&D Event on November 9th to Provide Detailed Insights into FX-322 Clinical Data, Plans for Continued FX-322 Development and New Pipeline Advancements for Hearing Loss and Multiple Sclerosis\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nFrequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced business updates and financial results for the second quarter ended June 30, 2021.\n\n“We have made important progress in our efforts to advance FX-322, our lead program for SNHL, toward its next step in clinical development. We are now completing a thorough analysis of our FX-322 exploratory clinical studies, which has served to increase our understanding of the etiologies and severities where hearing benefits have been observed in study subjects. Based on the overall learnings from multiple completed studies, we plan to initiate a randomized and well-controlled Phase 2 trial in the fourth quarter of this year, using a single administration of FX-322 in a refined population of subjects with SNHL. In addition, this trial will incorporate several novel study design elements that we believe will help address previously observed study bias,” said David L. Lucchino, Frequency’s Chief Executive Officer. “In the fourth quarter, we also intend to share topline data from our FX-322 Phase 1b learning study of subjects with severe SNHL (FX-322-113). Our plan is to maintain flexibility in the design of the new Phase 2 trial so we may also incorporate insights from the study of severe SNHL subjects.”\n\n“This November, we will host an R&D event for investors where we will detail findings from all of our FX-322 clinical studies. These insights have provided the basis for our enthusiasm in the program and have informed the design of our upcoming Phase 2 clinical trial. In addition, we plan to discuss other potential near-term and longer-term areas of pipeline expansion, including continued advancements in hair cell regeneration, as well as the progress we have made in our preclinical program for remyelination in multiple sclerosis (MS), our ...