UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On December 2, 2022, Stoke Therapeutics, Inc. (the “Company”) announced highlights from presentations at the American Epilepsy Society (AES) 2022 Annual Meeting related to its Phase 1/2a MONARCH and ADMIRAL studies of STK-001, as well as its open-label SWALLOWTAIL study, further supplementing initial data results reported on November 14, 2022.
Topline data from a combined interim analysis of six patients in the Phase 1/2a MONARCH and ADMIRAL studies treated with three doses of 45mg of STK-001 showed:
| • | a 55% median reduction from baseline in convulsive seizure frequency from day 29 after the first dose to three months after receiving the last dose; |
| • | reductions from baseline in convulsive seizure frequency in 5/6 (83%) patients; |
| • | a greater than 50% reduction in convulsive seizure frequency in 4/6 (67%) patients; and |
| • | reductions in seizure frequency began after the first dose and continued with additional treatment, consistent with the anticipated mechanism of action of STK-001. |
In addition, preliminary data from a small cohort of patients in the open-label SWALLOWTAIL study showed the effects of ongoing treatment with 30mg of STK-001, including:
| • | reductions in convulsive seizure frequency that were observed in MONARCH were maintained with ongoing treatment in the SWALLOWTAIL open-label extension study; |
| • | a trend toward improvement in non-seizure comorbidities as measured by the BRIEF-P, an assessment of executive function, was observed among patients in the SWALLOWTAIL open-label extension study. One-year data from the BUTTERFLY observational study, which did not include treatment with STK-001, showed little change from baseline to 12 months in the mean BRIEF-P scores and other commonly used cognition assessments; and |
| • | safety profile consistent with MONARCH and ADMIRAL. |
A copy of the press release regarding the above announcements is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Cautionary Note Regarding Forward-Looking Statements
This report contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to the ability of STK-001 to treat the underlying causes of Dravet syndrome and reduce seizures or show improvements in non-seizure comorbidities at the indicated dosing levels or at all, and the timing and expected progress of clinical trials, data readouts and presentations. Statements including words such as “plan,” “will,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they prove incorrect or do not fully materialize, could cause the Company’s results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, risks and uncertainties related to: the Company’s ability to advance, obtain regulatory approval of and ultimately commercialize its product candidates; the timing and results of preclinical and clinical trials; the risk that positive results in a clinical trial may not be replicated in subsequent trials or successes in early stage clinical trials may not be predictive of results in later stage trials and preliminary interim data readouts of ongoing trials may show results that change when such trials are completed; the Company’s ability to fund development activities and achieve development goals; the Company’s ability to protect its intellectual property; the direct and indirect impacts of the ongoing COVID-19 pandemic and its variants on the Company’s business; and other risks and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, its Quarterly Reports on Form 10-Q, and the other documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this report, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit Number |
Description | |
| 99.1 | Press release issued by Stoke Therapeutics, Inc., dated as of December 2, 2022. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| STOKE THERAPEUTICS, INC. | ||||||
| Date: December 2, 2022 | By: | /s/ Stephen J. Tulipano | ||||
| Stephen J. Tulipano | ||||||
| Chief Financial Officer | ||||||
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