KORRO BIO, INC. Item 7.01. Regulation FD Disclosure.
On
The information in Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
Item 8.01. Other Events.
On
FX-322-113 is a double-blind, placebo-controlled Phase 1b study designed to assess the local and systemic safety of a single dose of FX-322, and to evaluate hearing responses in a cohort of individuals with severe SNHL (pure tone average deficit between 71-90 decibel (dB) hearing level), a patient population that may have considerable damage to their inner ears and where cochlear implants may be the only potential intervention to improve hearing. Subjects were randomized 4:1 and received either FX-322 or placebo in one ear. Safety, otologic and audiologic assessments were conducted at days 30 and 90 following administration of FX-322 or placebo.
To gain a more comprehensive understanding of the potential impact of FX-322 in this population, the Company evaluated hearing function using multiple tests of speech perception in both quiet and noisy backgrounds, including the Bamford-Kowal-Bench Sentence-in-Noise exam (BKB-SIN). BKB-SIN is a validated test designed for severe SNHL populations (including cochlear implant patients), measuring the change in signal-to-noise ratios (SNR) required for a subject to correctly repeat words in a sentence.
In the FX-322-113 study, BKB-SIN test improvements were observed in four subjects, all of whom exceeded the 95 percent critical difference of 3.1dB SNR, with two subjects showing a 6dB response. A single placebo patient had a 3.6dB change. In the study, subjects did not show substantial changes in speech perception measures in quiet, the safety profile in the study was favorable and there were no treatment-related serious adverse events reported.
Forward-Looking Statements
This Current Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the interpretation and implication of the results and learnings of FX-322-113.
--------------------------------------------------------------------------------
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 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; the Company's
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; ability to seek
and receive Breakthrough Therapy designation for FX-322; the Company's ability
to enroll and retain patients in clinical trials; 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
These and other important factors discussed under the caption "Risk Factors" in
the Company's Form 10-Q filed with the
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibits relate to Items 7.01, and shall be deemed to be furnished, and not filed:
Exhibit No. Description 99.1Frequency Therapeutics, Inc. Corporate Slide Presentation as ofDecember 9, 2021 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
--------------------------------------------------------------------------------
© Edgar Online, source
