Phase III DERBY and OAKS studies of Empaveli show favourable safety profile in geographic atrophy.- Apellis Pharma
Apellis Pharmaceuticals announced longer-term data from the Phase III DERBY and OAKS studies of Empaveli (pegcetacoplan), which showed that intravitreal pegcetacoplan, an investigational, targeted C3 therapy, continued to reduce geographic atrophy (GA) lesion growth and demonstrate a favorable safety profile at month 18 for the treatment of GA secondary to age-related macular degeneration (AMD).
In a longer-term analysis of the primary endpoint, pegcetacoplan continued to reduce GA lesion growth compared to pooled sham at month 18 (all p-values are nominal).
In OAKS, pegcetacoplan reduced GA lesion growth with both monthly (22%; p<0.0001) and every-other-month treatment (16%; p="0.0018)." in derby, pegcetacoplan reduced ga lesion growth with both monthly (13%; p="0.0254)" and every-other-month treatment (12%; p="0.0332)." pegcetacoplan demonstrated marked improvements in derby during months 6-12 with reductions of 17% with monthly and 16% with every-other-month treatment compared to months 0-6, and the treatment effects were sustained through month 18. the treatment effects observed in derby were comparable with oaks during months 6-18. data at 18 months from the combined studies show the potential for improving treatment effects with pegcetacoplan over time. the reduction in ga lesion growth improved with monthly pegcetacoplan treatment from 13% to 21% from months 0-6 to months 12-18. the reduction in ga lesion growth improved with every-other-month pegcetacoplan treatment from 12% to 17% from months 0-6 to months 12-18. these data will be included in the new drug application (nda) that the company plans to submit to the fda in the second quarter of 2022.></0.0001)>
Related news and insights
- Deciphera Pharmaceuticals, Inc. announced that the Journal of Clinical Oncology has published results from its INTRIGUE Phase III study of Qinlock (ripretinib) in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib.
Nature Medicine has published results from a prospective, open-label, single-arm, phase II TUXEDO-1 trial of Enhertu (trastuzumab deruxtecan), from Daiichi Sankyo + AstraZeneca, which enrolled patients aged at least 18 years with HER2-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy, previous exposure to trastuzumab and pertuzumab and no indication for immediate local therapy
Biora Therapeutics, Inc. announced topline results from its recently completed study PM 602: A Scintigraphic Study to Evaluate the Localization and Delivery Function of a Drug Delivery System Capsule (DDS) in Subjects with Ulcerative Colitis in a Fasted State