Phase II study
The previous phase II, stage 1 DME study results indicated that ALG-1001 monotherapy was not inferior to bevacizumab and showed 12-week durability compared with monthly bevacizumab treatment.
The multicenter phase IIb stage 2 clinical trial evaluated the safety and efficacy of ALG-1001 compared with bevacizumab pre-treatment or combined with bevacizumab in 80 patients, 60% of whom had been treated chronically with anti-VEGF therapy.
The study had 3 arms: administration of 0.5 mg or 1.0 mg of ALG-1001 with bevacizumab pretreatment, administration of 0.5 mg or 1.0 mg of ALG-1001 and bevacizumab combination therapy, and a bevacizumab control arm of 5 monthly injections. The primary endpoint was the mean best-corrected visual acuity (BCVA) at week 20 with 12 weeks off of ALG-1001 treatment versus every-4-week bevacizumab injections, Dr. Boyer recounted.
At the 5-month follow-up evaluation, Dr. Boyer reported that the primary endpoint of BCVA non-inferiority was met. Regarding the 0.5-mg or 1.0-mg doses of ALG-1001 with the 1.25-mg dose of bevacizumab pretreatment, compared to the bevacizumab control, the mean BCVA showed non-inferiority through week 20.
“The (ALG-1001) results were achieved after 1 treatment of 1.25 mg bevacizumab (week 0) followed by 3, 1.0-mg (ALG-1001) injections at weeks 1, 4, and 8 followed by 12 weeks off of the treatment, compared to 5 injections of bevacizumab administered every 4 weeks. The data showed the mean letter gain in BCVA was 7.1 for patients in the group treated with ALG-1001 and bevacizumab pre-treatment (sequential) group compared to 6.7 letters for patients in the monthly bevacizumab-treated control group.
Importantly, no adverse effects related to ALG-1001 occurred.