LENZ Therapeutics anticipating NDA submission for LNZ100 or LNZ101 eye drops

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Subject to trial results, LENZ Therapeutics announced that is planning to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in mid-2024. This NDA would be for the commercialization of LNZ100 or LNZ101, which are preservative-free, single-use, once-daily eye drops that include aceclidine and aceclidine plus brimonidine, respectively.¹

“With clinical activities completed in each of the 3 Phase 3 CLARITY trials evaluating LNZ100 and LNZ101, we look forward to reporting topline results from these trials in April 2024 and, subject to successful completion of such trials, submitting an NDA to the FDA by mid-year,” said Eef Schimmelpennink, president and CEO of LENZ Therapeutics, in the release. “Backed by a strong balance sheet and supported by a proven management team and top-tier investors, we believe it is an exciting time for LENZ as we prepare to execute in a catalyst-rich year and, if approved by the FDA, potentially deliver the first aceclidine-based therapy intended to treat presbyopia.”

The NDA would also be based off findings from the company’s 3 CLARITY trials, which evaluated a primary efficacy endpoint of the percentage of participants who achieve 3-lines or greater improvement in near vision. Phases 1 and 2 evaluated this improvement 1 hours after treatment, with Phase 3 evaluating near vision improvement at 3 hours post-treatment.¹

The CLARITY trials were initiated after the completion of the company’s Phase 2 INSIGHT trial for both LNZ100 and LNZ101. In that trial, the eye drops achieved their primary endpoint of 3-lines or greater near vision improvement without losing 1 or more lines in distance vision at 1 hour post-treatment. After 3 hours, 73% of LNZ100 and 64% of LNZ101 patients maintained 3-lines or greater improvement, and after 10 hours, 37% of LNZ100 and 48% of LNZ101 patients maintained the same benchmark, with no participants experiencing serious drug-related adverse events.¹

Final visits for the last patients have been conducted in each of the CLARITY trials within the first quarter of 2024. The results from the trials’ findings will be reported in April 2024.¹

Merger

Tentative plans to submit the NDA arrive on the heels of the official merging of LENZ Therapeutics and Graphite Bio, which was initially announced in late 2023. The combined company will now operate under the name LENZ Therapeutics, Inc. and has started trading on Nasdaq under the ticker symbol “LENZ,” according to the release.

“Following the close of this transaction, we believe we are well-positioned to bring the opportunity of a once-daily pharmacological eye drop intended to improve near vision throughout the full workday closer to the 128 million people in the United States who are impacted by presbyopia,” Schimmelpennink said.

In terms of the companies’ reverse stock split, there were approximately 28 million shares of the combined company’s common stock outstanding at the closing of the merger, according to the release. Graphite Bio effected for a 1 for 7 reserve split of this common stock and issued a special cash dividend of $1.03 per share to Graphite Bio stockholders as of March 18.

The combined company will be led by Schimmelpennink as president and CEO. Other leadership will include current members of LENZ Therapeutics management Marc Odrich, MD, as chief medical officer and Shawn Olsson as chief commercial officer. Last week, Dan Chevallard was appointed as the company’s chief financial officer. Of the combined company’s 7 new board of directors, 1 will continue from Graphite Bio’s board of directors, 5 from LENZ’s board, and 1 who joined at the closing of the merger.¹

Updated April 2, 2024: A previous version reported 3-lines or greater improvement for 37% of LNZ100 patients and 48% of LNZ101 patients 3 hours after treatment. These percentages were reported 10 hours following treatment. The statement has been corrected.

Reference:

1. LENZ Therapeutics Announces Completion of Merger with Graphit Bio and Provides Update on Recent Clinical and Corporate Progress. LENZ Therapeutics. News release. Published March 21, 2024. Accessed March 28, 2024. https://ir.lenz-tx.com/news-events/press-releases/detail/9/lenz-therapeutics-announces-completion-of-merger-with-graphite-bio-and-provides-update-on-recent-clinical-and-corporate-progress