AKB-9778 with Lucentis improves central subfield thickness in DME

Patients with diabetic macular edema treated with a combination of AKB-9778 and Lucentis showed a significant reduction in central subfield thickness compared with patients treated with Lucentis alone, according to the Time-2 study results announced in a press release from Aerpio Therapeutics.

The three-armed phase 2a study included 144 patients with diabetic macular edema (DME) who were equally randomized to receive AKB-9778 (15 mg twice daily) as a monotherapy or in combination with Lucentis (ranibizumab, Genentech) therapy compared with Lucentis therapy alone. AKB-9778 is a human protein tyrosine phosphatase beta enzyme inhibitor. The treatment period was 3 months.

The study’s primary endpoint was mean change from baseline in central subfield thickness (CST), and secondary endpoints included visual acuity and safety outcomes.

Patients treated with the combination therapy had a “clinically significant benefit” in reduction of CST compared with patients treated with ranibizumab alone (P = .008), according to the release. As well, there was a positive trend in favor of the combination therapy vs. ranibizumab alone with regard to gaining three or more lines of visual acuity, Aerpio reported in the release.

“Most importantly, the combination approach has the potential to provide better outcomes for DME patients. We are actively planning the next stage of clinical development for this promising compound,” Joseph Gardner, CEO of Aerpio, said in the release.