jCyte announces plans to launch phase 3 clinical trial of cell therapy for retinitis pigmentosa

Key Takeaways

  • jCyte is planning to launch a pivotal, phase 3 clinical trial in the US for its emerging jCell therapy for RP during the second half of 2024.
  • jCells are designed to release proteins known as neurotrophic factors to preserve photoreceptors regardless of the mutated gene causing vision loss.

Retinitis pigmentosa (RP) is a group of rare, genetic disorders that involve a breakdown and loss of cells in the retina. The biotechnology company jCyte is preparing to launch a pivotal, Phase 3 clinical trial in the US for its emerging jCell therapy for RP after a successful planning meeting with the US Food & Drug Administration. The company plans to begin participant enrollment during the second half of 2024. More details of the trial are forthcoming.

jCells are similar to stem cells that haven’t yet fully developed into mature photoreceptors. The cells are injected into the vitreous, the soft, gel-like substance in the middle of the eye. Intravitreal injections have a good record of safety and are commonly administered for other conditions in a doctor’s office. jCells are designed to release proteins known as neurotrophic factors to preserve photoreceptors regardless of the mutated gene causing vision loss.

In an 85-patient Phase 2b clinical trial for jCells, 39 percent of patients receiving 6 million cells, the high dose of the treatment, had improvement in best correct visual acuity (BCVA) of 10 letters (two lines on an eye chart) or more. In the 3 million cell cohort, 16 percent had BCVA improvement of 10 or more letters. In the sham group, 19 percent had BCVA improvement of 10 or more letters. Significant improvements for treated eyes were also seen in contrast sensitivity, kinetic visual fields (uses moving lights instead of blinking lights to test for blind spots in your visual field), and mobility-related visual function.

Source: Eye on the Cure Research News, Foundation Fighting Blindness, February 24, 2024; see source article