WOBURN -
The Company has continued to advance the clinical development program for FX-322, its lead product candidate for the treatment of acquired SNHL, announcing last month a detailed update that includes an upcoming analysis of day-90 data from its Phase 2a study in late Q1 2021. This readout will assess all efficacy and safety endpoints following single or multiple doses of FX-322, or placebo. The Company also reiterated its plan to share end of Phase 2a data in late Q2 2021, evaluating the same metrics as at day-90, as well as the durability of the effect of FX-322 over seven months.
Further, Frequency is expanding its FX-322 development program to evaluate FX-322's clinical profile in other SNHL patient types, including those with age-related hearing loss and severe SNHL, in order to identify the broadest population that may benefit from the product candidate. The Company expects to share results from its Phase 1b age-related hearing loss study in Q2 2021 and its Phase 1b severe SNHL study in Q3 2021. SNHL is the most common form of hearing loss, impacting more than 40 million people in the US alone.
'This past quarter we continued to gain momentum, completing study enrollment and moving toward a day-90 readout of the Phase 2a study of FX-322, while expanding our development program by adding additional studies to further our understanding of the potential of FX-322 to help the broadest SNHL patient population. The analysis of day-90 data will enable us to evaluate our key goals for the Phase 2a study and provide a comparison to the hearing improvement signal we observed in our Phase 1/2 study. These data are also expected to provide critical insights as we look ahead to the end-of-study readout late in the second quarter of next year and enable us to plan our longer-term development and regulatory strategies,' said
'We look forward to an eventful 2021, with multiple FX-322 data readouts. We also expect to move our therapeutic candidate for remyelination in multiple sclerosis to the clinic in the second half of next year and further our exploration of additional opportunities for our progenitor cell activation approach.'
Recent Program and Business Updates
FX-322 Phase 2a Study and Pending Clinical Readouts: The FX-322 Phase 2a study is a double-blind, placebo-controlled single and repeat dose study in patients aged 18 to 65 with acquired SNHL. The study includes four dose cohorts, with hearing function being regularly tested in all patients over the course of the full seven months following the first dosing.
The key efficacy objectives of the study are to evaluate the potential of FX-322 to improve hearing clarity or intelligibility, as measured by improvements in tests of word recognition (WR) or words-in-noise (WIN). Data will also be analyzed for the impact of FX-322 on pure tone audiometry in the standard frequencies (0.25-8 kHz), at higher frequencies (up to 16k Hz) and on tinnitus and quality of life measures. Frequency expects to share day-90 study results in late Q1 2021 and end of study results in late Q2 2021.
In its previously disclosed Phase 1/2 study, Frequency observed improvements in key measures of hearing function, specifically speech intelligibility, following a single dose of FX-322 in patients with moderate to moderately severe acquired SNHL. The evaluation period for the Phase 1/2 study was 90 days.
At the
The results of the Phase 2a end of study analysis, as well as anticipated results from the age-related hearing loss and severe SNHL studies, are expected to provide the basis for an end of Phase 2 meeting with the
FX-322 Phase 1b Study for Age-Related Hearing Loss: In October, the Company announced that the first patient was dosed in a Phase 1b safety study of FX-322 for age-related hearing loss. The study is a double-blind, placebo-controlled, randomized multicenter safety study of up to 30 patients aged 66-85 with mild to moderately severe age-related hearing loss. The primary objectives of the Phase 1b study are to assess the local and systemic safety of a single dose of FX-322 and evaluate the hearing response. Study participants are being randomized 4:1 to receive either FX-322 or placebo in one ear. The study is using validated measures of hearing function including WR, WIN and pure tone audiometry to assess the effect of FX-322. Safety, otologic and audiologic assessments will be conducted at days 30 and 90 following administration. Frequency expects to share these study results in Q2 2021.
FX-322 Phase 1b Study of Severe SNHL: Frequency plans to start a Phase 1b study in patients aged 18-65 with severe SNHL before year-end. Severe SNHL is defined as a pure tone average deficit between 71-90 dB. Many patients with this clinical profile typically would be candidates for cochlear implants. This study is expected to employ a similar design to the age-related Phase 1b study that is currently underway. Frequency expects to share results from this study in Q3 2021.
Continued Progress on Earlier Stage Pipeline: The Company continued to make progress in its program for remyelination in multiple sclerosis, advancing the program from discovery into the pre-clinical phase. The program remains on track for an anticipated regulatory submission in H2 2021.
Cynthia Feldmann Appointed to Board of Directors: In September,
New England Innovation Awards Life Science Winner: In October, Frequency was named the winner in the life sciences category of the New England Innovation Awards for its research into and development of FX-322 for sensorineural hearing loss. The award recognizes companies for their efforts to develop transformative innovations that can have a positive impact on patients, industry and society.
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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 Phase 2a clinical trial, the Phase 1b study of age-related hearing loss, the Phase 1b study of severe SNHL, including timing of commencement thereof, design, pace and timing of enrollment and results for the Phase 1b studies in age-related hearing loss and severe SNHL, the timing and completion of analysis of Phase 2 clinical trial data and data readouts from the Phase 2a clinical trial and the Phase 1b studies in age-related hearing loss and severe SNHL, the expected insights of such readouts and resulting developments, the effectiveness of the current standard of care to address the primary unmet need of patients with acquired SNHL, the timing of a regulatory submission of a product candidate for remyelination in MS and commencement of clinical trials, the ability of our technology platform to provide patient benefit, the impact of COVID-19 on the Company's on-going and planned clinical trials and business, increases in headcount, future milestone and royalty payments under the license and collaboration agreement with Astellas, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company's ability to advance its hearing program and further diversify its portfolio, the potential application of the PCA platform to other diseases and expectations regarding cash, cash equivalents and short-term investments.
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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