Item 8.01. Other Events.
On
FX-322-208 is a randomized, placebo-controlled, multi-center study designed to evaluate the impact of a single administration of FX-322 on speech perception in approximately 124 subjects with SNHL. The study's primary endpoint is speech perception, a measure of sound clarity and understanding speech. The Phase 2b study's inclusion criteria are designed to enroll subjects with the same hearing loss severities and etiologies as those subjects in which statistically significant improvements in speech perception were observed in prior FX-322 clinical studies. FX-322-208 will include subjects with hearing loss associated with either noise-induced or sudden SNHL.
The
In two previous clinical studies, the Company observed statistically significant improvements in speech perception scores in individuals with acquired sensorineural hearing loss. These studies are FX-322-201, a randomized placebo-controlled study of subjects with mild to moderately severe SNHL, and FX-322-111, an open-label study evaluating different FX-322 administration conditions, where nine of 32 subjects that completed the study showed speech perception improvements between 90 days and one year following administration. To date, more than 175 individuals have been dosed with FX-322 across previous studies and no drug-related serious adverse events have been reported.
The Company will maintain flexibility in the overall FX-322-208 design in order to be able to include additional etiologies and severities based on pending results from its ongoing FX-322 study in severe subjects (FX-322-113).
FX-322-208 is expected to be conducted at approximately 25 U.S.-based study sites consisting of both private ENT clinics and academic medical centers.
Forward-Looking Statements
This Current Report of Form 8-K (the "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 design of the new Phase 2b trial of FX-322, including the number of patients that will be enrolled, the type of SNHL that these patients will have, the number of study sites, and the measurements used in the study, the interpretation and implications of the results and learnings of other FX-322 clinical studies, including the FX-322-111, FX-322-201, and FX-322-113 studies, the acceptance by the FDA of particular endpoints in the Company's trials, and the treatment potential of FX-322.
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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'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
These and other important factors discussed under the caption "Risk factors" in
the Company's Form 10-Q filed with the
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