Newly Listed Lenz Therapeutics' Vision Loss Experimental Drug Meets Primary Goal In Late-Stage Study
On Wednesday, LENZ Therapeutics Inc (NASDAQ:LENZ) released topline results from its Phase 3 CLARITY study of two investigational formulations of aceclidine, LNZ100 and LNZ101.
Presbyopia is the gradual loss of the eyes’ ability to focus on nearby objects that impact people over 45 years.
Lead product candidate LNZ100 (1.75% aceclidine) achieved the primary endpoints and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one line or more in distance visual acuity.
In the vehicle-controlled CLARITY 2 trial, the Day 1 results showed:
- Rapid onset: 71% and 91% of participants achieved three- and two-lines or greater improvement, respectively, and for CLARITY 1, 72% and 87% of participants achieved three- and two-lines or greater improvement, respectively, at 30 minutes.
- Primary endpoint: For CLARITY 2, 71% and 91% of participants achieved three- and two-lines or greater improvement, respectively, and for CLARITY 1, 64% and 83% of participants achieved three- and two-lines or greater improvement, respectively at 3 hours.
- Long duration: 40% achieved three-lines or greater improvement at 10 hours.
Near vision improvement was reproducible and consistent across CLARITY 1 and 2 throughout the four-week study periods.
LNZ100 was well-tolerated, with no serious treatment-related adverse events observed in the over 30,000 treatment days across all three CLARITY trials.
LNZ101 showed similar results, including achieving primary and secondary endpoints in CLARITY 1 and 2, but did not show superiority to LNZ100. Hence, LENZ selected LNZ100 as its lead product candidate, for which it plans to submit a New Drug Application in mid-2024.
Near vision improvement was reproducible and consistent across CLARITY 1 and 2 throughout the four-week study periods.
LNZ100 was well-tolerated, with no treatment-related serious adverse events observed.
Price Action: LENZ shares are up 4.33% at $21.92 on the last check Wednesday.
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