Results

On a roll, Apellis adds positive PhII C3 data for AMD drug, preps for PhIII

Cedric Francois

Just days after grabbing a $60 million round to fund a Phase III program for a rival therapy to Alexion’s Soliris, Louisville, KY-based Apellis is back with a positive readout on its mid-stage trial for age-related macular degeneration.

The biotech has been focused on what it believes is a better way of shutting down several disease pathways using a complement C3 inhibitor. In the AMD study, which recruited 246 AMD patents with geographic atrophy at 40 clinical sites, Apellis’ drug APL-2 — delivered monthly — produced a 29% average reduction in the rate of geographic atrophy lesion growth over 12 months.

In a post hoc analysis of the data, the researchers saw the effect grow to 47% for monthly dosing in the second 6 months. Injected every other month, the results were 20% after 12 months and 33% in the second 6 months

CEO Cedric Francois said the plan now is to launch a Phase III program “as soon as possible.” Apellis has outlined plans for multiple disease programs using its C3 inhibitor.

Apellis has had a run of upbeat news in recent months. In late June investigators reported on two tiny studies for rare cases of PNH involving 3 and 6 patients. In 3 patients never treated with Soliris, investigators reported that all of them experienced a quick correction on a key biomarker for lactate dehydrogenase, or LDH. In 6 patients not responding well to Soliris, the average hemoglobin level was brought up an average of 36%, LDH was corrected and transfusions dropped from 3.4/month on eculizumab monotherapy to 0.3/month when APL-2 was added to eculizumab. And the biotech raised no unusual red flags on the safety side.

David Boyer of Retina-Vitreous Associates Medical Group, had this to say on today’s AMD data:

“These results are very exciting for all people afflicted with dry AMD with geographic atrophy. It is currently an untreatable condition, and the reduction of the progression of atrophy in this trial offers new hope for vision maintenance for our patients.”


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