CORXEL and LENZ Therapeutics announce positive topline data from China phase 3 presbyopia trial of LNZ100

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Corxel Pharmaceuticals (CORXEL) and LENZ Therapeutics released positive topline data from the phase 3 JX07001 clinical trial of LNZ100 (1.75% aceclidine HCl, a miotic) in presbyopic Chinese patients.

The phase 3 safety and efficacy results showed that the drug met the primary endpoint and key secondary endpoints, with 3 lines or more improvements in the best-corrected distance visual acuity (VA) at near and the patients maintained their optimal distance VA, defined as no loss of 5 or more letters, according to a press release.

“We would like to first congratulate the team at CORXEL for their effort in their Phase 3 clinical study in China. We are pleased with the impressive and consistent performance demonstrated by LNZ100 in our collective studies, further validating the vision of targeting an ‘all eyes, all day’ solution,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “With this data, we believe LNZ100 has further enhanced its potential as a global therapy and is further on its path towards providing access to the estimated 400 million people with presbyopia in China. This data signifies a tremendous joint effort between the CORXEL and LENZ teams and comes in rapid succession to the recent FDA acceptance of our New Drug Application for LNZ100 in the United States.”

The companies also released the following additional findings:

• LNZ100 exhibited rapid onset, with 84% and 69% achieving 2-lines and 3-lines or greater improvement at 30 minutes following instillation, respectively.
• At 3 hours post-treatment: 88% and 74% achieved 2-lines and 3-lines or greater improvements, respectively, and maintained their optimal distance VA, ie, no loss of 5 or more letters.
• LNZ100 demonstrated a long duration of effect: 61% and 30% achieved 2-lines and 3-lines or greater improvement at 10 hours, respectively.

All of these results reached significance (P < 0.0001 for all comparisons).

In addition, LNZ100 was well tolerated with no serious treatment-related adverse events observed.

“We believe their data is impressive and very consistent with the data from our CLARITY study (e.g., all primary endpoints met; 74% 3L gain at 3 hours versus our 71% 3L gain at 3 hours and similar safety profile)," said Schimmelpennink. "We believe this particularly telling as the JX07001 clinical study was performed by a different sponsor, in a different country, with a different predominant participant demographic/ethnicity, highlighting the unique profile of LNZ100 as providing near universal near vision improvement across different populations.”

Phase 3 study of LNZ100

The phase 3, multicenter, randomized, double-blind, vehicle-controlled study included a 4-week efficacy study followed by a 5-month extension safety study to evaluate the efficacy and safety of LNZ100 for treating presbyopia. The study objectives were to assess the potential of LNZ100 to improve near vision among Chinese presbyopic patients and to evaluate the efficacy and safety profiles.

The trial included 300 participants between 45 and 75 years of age with a refractive range of -4.0 to +1.0 diopters of spherical equivalent, including those who had undergone laser-assisted cornea refractive surgery/monofocal intraocular lens implantation.

Professor Jia Qu, Principal Investigator and Co-Principal Investigator, Vice Chairman of Ophthalmology Branch, Chinese Medical Association, Director of optometry department, Wenzhou Medical University commented on the study findings. “We are very pleased with the results of the LNZ100 trial, particularly the significant efficacy and favorable safety profile of LNZ100 in patients with presbyopia, demonstrating an important advance in the field of presbyopia treatment in China. Currently, patients mainly rely on wearing eyeglasses as treatment for presbyopia. There is a large unmet need for non-invasive and reversible treatments. We expect that LNZ100 will fill this vacuum and become an innovative force in the treatment of presbyopia in China, providing more patients with the hope of clear vision."

Professor Fan Lyu, Principal Investigator and Co-Principal Investigator, Head of the Optometry Working-Group under Ophthalmology Branch, Chinese Medical Association, Director of National Clinical Medical Research Centre for Eye Diseases, explained the drug’s mechanism of action: "The main active ingredient of LNZ100, aceclidine, causes temporary pupil constriction, resulting in an optical effect that significantly extends the depth of focus and improves the quality of vision. The statistically significant data and clinically meaningful outcomes observed in the trials provide strong support for the efficacy and safety of LNZ100. We anticipate that LNZ100 will be a practical treatment option for a wide spectrum of patients and will have a favorable impact on paradigm shift of helping improve near-vision in the Chinese presbyopia population.”