Item 7.01 | Regulation FD Disclosure. |
On September 20, 2022, Wave Life Sciences Ltd. (the “Company” or “Wave”) issued a press release announcing a positive update to its ongoing Phase 1b/2a SELECT-HD trial of WVE-003, the Company’s clinical candidate for Huntington’s disease (HD). SELECT-HD is an adaptive trial designed to rapidly optimize dose level and frequency based on early indicators of target engagement. The trial update was driven by the observation of reductions of mutant huntingtin (mHTT) protein in cerebrospinal fluid (CSF) after study participants received either a single 30 or 60 mg dose of WVE-003. In addition, wild-type huntingtin (wtHTT) protein was preserved, which appears consistent with allele-selectivity. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.
The press release also indicated that Wave management will host an investor conference call at 8:30 a.m. ET on September 20, 2022 to discuss these initial results and provide a business update. For purposes of the call, and in connection with the announcement described above, the Company plans to share an investor slide presentation during the investor conference call, which will be available on the “For Investors & Media” section of the Company’s website at http://ir.wavelifesciences.com/.
The information in this Item 7.01 is being 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 into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
The information set forth in the press release referred to in Item 7.01 above, other than the second, third and ninth paragraphs thereof, is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits