David Boyer, MD, talks about the topline results from a prospective, double-masked phase 2b clinical trial evaluating ALG-1001 compared to Bevacizumab in patients with DME.
David Boyer, MD: The DELMAR study indicated that the treatment with 3 injections of the integrant ALG-1001 was equivalent to monthly injections of Bevacizumab when looked at, at week 24. Coupling with the results from the first study, part 1 of the DELMAR study, we embarked on a study where we would treat the VEGF with 1 shot of Bevacizumab, and then again 3 subsequent shots basically at week 1, week 4, and week 8, with a read-out at week 20, in the second part of the DELMAR study.
Part of that study was also a combination trial where the 2 drugs were administered simultaneously over a set period time. In the combination trial, it did not show an improvement. It appears the 2 drugs together don't work independently, and there may be some competitive problems associated with combining the 2 drugs. But it seems that the 0.5 mg and the 1 mg dose [of ALG-1001] both showed equivalency to monthly injections of Bevacizumab, with 12 weeks off of treatment. This was a hard-to-treat group of people, meaning that these patients had multiple anti-VEGF injections.
There are 2 things. First, it's a completely different mode of action, and the fact that you may have a much longer ability with fewer injections is very appealing, both to the patient [and the clinician] if you can continue to maintain the excellent visual results that VEGF therapy doesn't show. The other thing is that there may be an advantage in some patients - difficult to treat patients, patients that don't seem to respond very well to anti-VEGF - that this may provide additional improvements overall, in vision. So, we'll go to a phase 3 to determine if that is the case.