Frequency Therapeutics Holds Virtual R&D Event Highlighting Clinical Advancement of FX-322, a New Potential Restorative Treatment for Hearing Loss and In Vivo Data for Its Remyelination Program in Multiple Sclerosis

Rhea-AI Summary

Frequency Therapeutics (FREQ) is hosting a virtual R&D event to discuss completed clinical data for FX-322 in patients with sensorineural hearing loss (SNHL). The company highlights significant clinical improvements in speech perception and FDA alignment on this as a primary efficacy endpoint. Additionally, it introduces FX-345 for a broader cochlear approach to SNHL treatment and discusses promising remyelinating agents for multiple sclerosis (MS). The event features insights from key executives and experts, underscoring the potential of their regenerative therapies.

Positive

• Completion of four FX-322 clinical studies with 169 subjects showing statistically significant improvements in hearing.
• FDA alignment on speech perception as a primary efficacy endpoint for the FX-322-208 study.
• Introduction of FX-345, designed for expanded cochlear distribution, potentially benefiting a larger SNHL patient population.
• Promising preclinical data for FREQ-162 in MS, showing substantial remyelination activity.

Negative

• None.

Management and Leading KOLs will Provide Detailed Review of Completed FX-322 Clinical Data in Subjects with Sensorineural Hearing Loss (SNHL), Supporting Design of FX-322-208 Phase 2b Study

New Hearing Restoration Program Advances Toward Clinical Studies Providing Broader Cochlear Exposure with the Potential to Address Expanded SNHL Patient Populations

Novel Remyelinating Agent Against a New Biological Target Being Advanced for Multiple Sclerosis (MS); In Vivo Data Show Substantially Greater Activity than Biologic or Small Molecule Comparators

LEXINGTON, Mass.--(BUSINESS WIRE)-- Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a person’s innate regenerative potential to restore function, today will host a virtual R&D event. The webcast can be accessed here.

“We look forward to highlighting the extensive data supporting our Phase 2b study (FX-322-208) in patients with sensorineural hearing loss (SNHL), where we have seen clear clinical improvements in speech perception in patient groups that include millions of individuals in the US alone. We have alignment with the FDA on speech perception as the primary efficacy endpoint and will detail the importance of this measure for patients. Our Phase 2b study is enrolling subjects who we believe fit squarely in the range where we have seen clinically meaningful hearing improvements, and we will detail the design of this study,” said David L. Lucchino, Frequency’s Chief Executive Officer.

Mr. Lucchino continued: “We will also unveil two new research programs that demonstrate the potential of our progenitor cell activation (PCA) approach. First, we will introduce FX-345, a new hearing restoration candidate designed for greater distribution through the cochlea, potentially enabling the treatment of expanded SNHL patient populations. We also have a highly promising novel therapeutic approach for multiple sclerosis, remyelinating agents that demonstrate a level of activity that far exceeds alternatives that have been developed to date.”

Event Highlights:

FX-322

• Clinical data review from four completed FX-322 clinical studies, including 169 subjects with a range of hearing loss severities and SNHL etiologies (sudden, noise-induced, age-related).
• Analysis of statistically significant and clinically meaningful patient responses following a single FX-322 administration, establishing the range of severity and etiologies that will be explored in the upcoming FX-322-208 study.
• Review of design of ongoing FX-322-208 study, including use of multiple lead-in hearing measures implemented to reduce study bias and baseline variability.
• Alignment with the U.S. Food and Drug Administration around speech perception measures as a primary efficacy endpoint and the importance of speech perception as the key unmet need for individuals with SNHL.

FX-345

• Introduction of new SNHL investigational therapeutic program, including a more potent GSK3 inhibitor designed to achieve broader exposure of the cochlea.
• Preclinical pharmacokinetic measures and human modeling data, indicating that therapeutically active FX-345 drug levels will be reached in areas of the cochlea corresponding to a wider range of hearing frequencies.
• Potential to benefit an expanded SNHL patient population.
• IND anticipated in Q2 2022.

Remyelination in Multiple Sclerosis

• Identified novel therapeutic target that drives oligodendrocyte progenitor cell differentiation and myelination.
• FREQ-162, preclinical stage lead compound, induces substantially more remyelination than published, comparator approaches.
• FREQ-162 being advanced in preclinical safety studies toward the initiation of clinical development.

Event Details and Agenda:

The webcast event will be held today, November 9, 2021, from 8 a.m. to 10 a.m. EST, and will include a live Q&A session. Presentations by Frequency management and academic subject matter experts will include:

David L. Lucchino, Chief Executive Officer: Strategic Company overview

Robert S. Langer, ScD, Frequency Therapeutics co-founder and MIT Institute Professor: Pioneering a new category in regenerative medicine

Carl LeBel, PhD, Chief Development Officer: Key learnings from FX-322 hearing restoration program and clinical development path

Sumit Dhar, PhD, Hugh Knowles Professor of Hearing Science and Associate Provost for Faculty at Northwestern University: Cochlear pathology and the impact of high frequencies on speech perception

Kevin Franck, PhD, SVP, Strategic Marketing and New Product Planning: FX-322 clinical data and real-world impact of speech perception improvements

Steven D. Targum, MD, Independent Consultant, Scientific Director, Signant Health: Best-practice approaches for addressing placebo response in clinical trials

Christopher Loose, PhD, Chief Scientific Officer: New regenerative programs from continued progenitor cell activation (PCA) research, and a new hearing program for sensory hair cell regeneration

Sanjay Magavi, PhD, VP, Myelination Research: Remyelination for multiple sclerosis: Discovery of a novel target with exceptional in vivo activity

To register for the event, please visit: https://investors.frequencytx.com/2021_Virtual_R-D_Event. An archived replay will be available for at least 30 days following the presentation.

About Frequency Therapeutics

Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore function – first in hearing loss and then in multiple sclerosis (MS) – by developing therapeutics that activate a person’s innate regenerative potential within the body through the activation of progenitor cells. Frequency’s hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also following early restorative signals in MS to develop medicines with the same underlying regenerative science being brought to hearing loss.

Headquartered in Lexington, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, the Scripps Research Institute and Cambridge Enterprises Limited. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the design of the new Phase 2 trial of FX-322, including the type of SNHL that the enrolled patients will have and the ability of design features to reduce bias, the interpretation and implications of the results and learnings of other FX-322 clinical studies, the acceptance by the FDA of particular endpoints in the Company’s trials, the treatment potential of FX-322, FX-345, and the novel approach for remyelination in multiple sclerosis, the timing and progress of the FX-345 and remyelination programs, the speakers, timing of and topics to be discussed during the R&D event, the ability of our technology platform to provide patient benefit, the ability to continue to develop our Progenitor Cell Activation (PCA) platform and identify additional product candidates, and the potential application of the PCA platform to other diseases.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company’s ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company’s offices and laboratory facilities, the Company’s business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company’s need for additional funding to complete development and commercialization of any product candidate; the Company’s dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

These and other important factors discussed under the caption “Risk factors” in the Company’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2021 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211109005328/en/

Investor Contact:

Carlo Tanzi, Ph.D.

Kendall Investor Relations

ctanzi@kendallir.com

617-914-0008

Media Contact:

Suzanne Day

Frequency Therapeutics

sday@frequencytx.com

781-496-2211

Source: Frequency Therapeutics, Inc.

FAQ

What are the key findings from Frequency Therapeutics' FX-322 clinical studies?

The FX-322 clinical studies involved 169 subjects and demonstrated statistically significant improvements in speech perception among patients with sensorineural hearing loss.

What new therapies did Frequency Therapeutics introduce during the R&D event?

Frequency Therapeutics introduced FX-345, designed for broader cochlear exposure, and a novel remyelinating agent FREQ-162 for treating multiple sclerosis.

When is the Phase 2b study (FX-322-208) expected to start?

The Phase 2b study (FX-322-208) is currently enrolling subjects, with no specific start date mentioned in the press release.

What is the significance of the FDA alignment mentioned in the press release?

The FDA alignment on speech perception as a primary efficacy endpoint validates its importance for patients with sensorineural hearing loss during the FX-322-208 study.

What is the anticipated IND submission date for FX-345?

The IND submission for FX-345 is anticipated in the second quarter of 2022.