Endogena Therapeutics has concluded the dose-escalation stage of its Phase l/lla trial of EA-2353 to treat retinitis pigmentosa (RP).
The firm has not found any clinically important or dose-limiting adverse events after administering repeated intravitreal injections to the subjects during this phase.
Based on the positive safety and tolerability results, the trial will now include patients for the expansion cohort, where the highest dose will be given to patients to find the possible efficacy of EA-2353.
Endogena lead investigator and Casey Eye Institute Ophthalmology professor Mark Pennesi conducted the Phase l/lla trial to evaluate EA-2353’s safety, tolerability and preliminary efficacy given by intravitreal injection to RP patients.
Altogether 14 patients with RP as a result of any pathologic genetic mutation are being enrolled at around six US sites.
In July last year, first patient of the trial was dosed. So far, nine patients have been treated in the dose escalation phase of the trial.
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EA-2353 is a gene-independent treatment that uses a small-molecule approach and selectively activates endogenous retinal stem and progenitor cells, which differentiate into photoreceptors and could preserve or restore visual ability.
Endogena Therapeutics CEO Matthias Steger said: “We are edging closer to a treatment for this devastating condition, and I’m very encouraged by the safety and tolerability profile in this dose escalation stage.
“We have the best people working tirelessly to bring this novel treatment to the patients who need it as fast as possible.”