APX3330 shows favorable safety, tolerability for treatment of DR and DME
APX3330, an oral drug, demonstrated a favorable safety and tolerability profile in the treatment of diabetic retinopathy (DR) and diabetic macular edema (DME), according to data presented from multiple Phase 1 and 2 studies presented at the 2021 ASRS Annual Meeting.
APX3330 was evaluated in >300 health volunteers and patients with chronic hepatitis across five Phase 1 and 5 Phase 2 clinical studies at doses up to 600 mg/day. A sixth Phase 1 trial of 19 patients with solid tumors receiving APX3330 twice daily of doses up to 720 mg/day was also undertaken.
In the 5 Phase 1 trials, <10% of participants receiving APX3330 reported mild diarrhea compared to 0% in those treated with placebo. In the sixth Phase 1 trial, a diffuse skin rash was seen in 2 patients receiving 720 mg/day; the rash was resolved when patients switched to a dose of 600 mg/day, which was defined as the maximum tolerated dose. A dose of 600 mg/day was taken by 4 patients for >6 months and by 3 patients for >300 days without issue.
In 5 Phase 2 trials, <5% of the patients experienced adverse events and rates were similar between patients receiving placebo and APX3330. Occasional mild diarrhea was noted with APX3330. One patient reported mild orbital discomfort.
APX3330 is currently being investigated in an ongoing, randomized, placebo-controlled Phase 2 trial for the treatment of DR and DME.
Allingham MJ, et al. APX3330, an Oral Drug in Trial for DR and DME, Demonstrated a Favorable Safety and Tolerability Profile in Multiple Phase 1 and 2 Studies. Presented at: 2021 ASRS Annual Meeting.