Frequency Therapeutics Inc. (NASDAQ: FREQ) stock declined by 1.46% at the last close whereas the FREQ stock price surges by 5.19% in the pre-market trading session. Frequency Therapeutics is at the forefront of a new regenerative medicine category aimed at restoring human function, first in the case of hearing loss and subsequently in the case of multiple sclerosis.
FREQ stock’ Update
The first participant in a new FX-322 Phase 2b trial (FX-322-208) being undertaken in a refined sample of patients with SNHL has been dosed, according to Frequency Therapeutics.
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FX-322-208 is a multi-center, randomized, placebo-controlled research that aims to see how a single dose of FX-322 affects speech perception in about 124 people with SNHL. Speech perception, a measure of sound quality and comprehending speech, is the study’s major objective. The inclusion criteria for the Phase 2b trial are aimed to enroll participants with the very same hearing impairment severity and etiologies as those who showed considerable improvement in speech perception in previous FX-322 clinical investigations. Subjects in FX-322-208 will have hearing loss as a result of either noise-induced or abrupt SNHL.
In a recent Type-C meeting with the Company, the US Food and Drug Administration (FDA) confirmed that speech perception is an acceptable main effectiveness objective. A number of different hearing tests will be conducted, including several measures of speech perception and pure tone thresholds.
The company has shown considerable improvement in speech perception ratings in those with developed sensorineural hearing loss in two prior clinical investigations. FX-322-201 is the first study, which is a randomized placebo-controlled trial including patients with mild to moderately severe SNHL. FX-322-111 is the second study, which is an open-label trial assessing various FX-322 administration settings. More than 175 people have been dosed with FX-322 in prior studies, and no significant drug-related side effects have been recorded.
On November 9, 2021, Frequency intends to conduct an R&D event. The company will go over the trial findings for FX-322 in detail and explain the data that supports the design and inclusion criteria for FX-322-208. Given the awaiting results from its ongoing FX-322 research in severe patients, the Company will preserve flexibility in the overall FX-322-208 design in terms of being able to include new etiologies and severities (FX-322-113).