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LENZ Therapeutics announces positive results from Phase 3 CLARITY trials

News
Article

The company selected LNZ100, designed to treat presbyopia, as its lead candidate and expects to submit an NDA in mid-2024.

Closeup of researcher looking into microscope Image Credit: AdobeStock/megaflopp

Image Credit: AdobeStock/megaflopp

Late clinical-stage biopharmaceutical company LENZ Therapeutics has announced positive topline results from its Phase 3 CLARITY study of 2 investigational formulations of aceclidine, LNZ100 (1.75% aceclidine) and LNZ101, designed to treat presbyopia. LNZ100 was selected as the company’s lead candidate, with the primary endpoint met with 71% of participants achieving 3 lines or greater improvement in 3 hours.1

“We are very pleased with the outcome of the CLARITY trials, and most importantly the strong efficacy and safety profile of LNZ100 observed in patients with presbyopia. We would like to thank our investigators, clinical sites, and all participants in our study,” said Eef Schimmelpennink, president and CEO of LENZ Therapeutics. “We believe these data support LNZ100 as a potential best-in-class therapy for the treatment of presbyopia. The high responder rate, rapid onset and long duration across a broad range of presbyopes ranging from 45 to 75 years of age and having a refractive range from -4.0 to +1.0 D SE are consistent with features that patients are expecting from an effective treatment option. Based on these highly encouraging data, we will direct our focus towards our NDA submission in mid-2024 for LNZ100, and preparations for commercialization in second half of 2025 upon FDA approval, with the goal of moving closer to helping many of the 128 million people experiencing symptoms of presbyopia in the United States.”

For rapid onset, 71% of participants achieved 3 lines or greater improvement at 30 minutes. For long duration, 40% achieved 3 lines or greater improvement at 10 hours.1 LENZ Therapeutics stated in the release that near improvement “was reproducible and consistent across both CLARITY 1 and 2 through the 4-week study periods.” Additionally, LNZ100 was well-tolerated with no serious treatment-related adverse events in the over 30,000 treatment days across all 3 CLARITY trials. The only adverse events reported at 5% incidence or more were installation site irritation, visual impairment, and hyperemia, which were all stated as mild. For headaches experienced, 89% stated they were mild.1

“These positive CLARITY study data build on the compelling results from our INSIGHT trials, demonstrating a robust safety and efficacy profile for the use of aceclidine to treat presbyopia,” said Marc Odrich, chief medical officer of LENZ Therapeutics. “Presbyopes often experience an abrupt change in their daily life as the symptoms become progressively pronounced starting in their mid-40s, when reading glasses or other corrective aids often become necessary to read, text or conduct close-up work. The statistically significant data and clinically meaningful outcomes observed in the CLARITY trials support the potential paradigm-shifting impact LNZ100 can have as an alternative and convenient therapeutic option to reading glasses.”

The company said in the release that a New Drug Application submission is still anticipated in mid-2024.1

Reference:
  1. LENZ Therapeutics announces positive topline data from Phase 3 CLARITY Presbyopia Trials. LENZ Therapeutics. News release. Published April 3, 2024. Accessed April 9, 2024. https://ir.lenz-tx.com/news-events/press-releases/detail/11/lenz-therapeutics-announces-positive-topline-data-from-phase-3-clarity-presbyopia-trials
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