Pre-IND meeting with FDA completed with positive feedback on clinical and nonclinical development plans for PAS-nomacopan in treatment of geographic atrophy
BOSTON and LONDON, August 19, 2024 (GLOBE NEWSWIRE) — Akari Therapeutics announced today that the company has received positive and constructive Pre-IND (PIND) feedback from the FDA on July 29, 2024, which provides additional clarity on Akari’s final Investigational New Drug Application (IND)- enabling preclinical plans, drug manufacturing and Phase 1 clinical strategy for long-acting PAS-nomacopan for intravitreal treatment of geographic atrophy (GA).
PAS-nomacopan is a long-acting bispecific inhibitor of C5 and leukotriene B4 (LTB4) product candidate that Akari believes has the potential for longer dose intervals between intravitreous injections than currently approved complement only inhibitors, as well as potential reduction of the choroidal neovascularization (CNV) risk that is associated with approved inhibitors. CNV is a sight-threatening over development of blood vessels within the retina, which is typically treated with additional anti-vascular endothelial growth factor (VEGF) intravitreal injections.
A full-scale batch of drug substance was recently successfully manufactured and released under applicable Good Manufacturing Practices (GMP) conditions by our manufacturing partner, Wacker Biotech GmbH, and is planned to be used for both the final IND-enabling studies and initial clinical development.
The regulatory feedback from the FDA and production of GMP material enables a clear path forward to submitting an IND, with the IND expected to be submitted in 2025.
Dr. Miles Nunn, Chief Scientific Officer of Akari Therapeutics said, “We thank the FDA for its positive and constructive feedback,” and added, “The PIND feedback enables us to align our final IND-enabling non-clinical plans with the FDA’s advice, strengthening PAS-nomacopan’s progress towards Phase 1 clinical studies for treatment of GA.”
Samir R Patel, MD, Interim CEO of Akari said, “I’m very pleased with the progress that is being made in bringing PAS-nomacopan closer to the clinic as we believe it has the potential to offer an improved therapy for treatment of GA via longer dose intervals and reduction in CNV risk which could offer clinically meaningful benefits to patients.” He added, “We look forward to filing an IND application in 2025 for our first clinical studies of PAS-nomacopan for treatment of this disease.”
About Akari Therapeutics
Akari Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company developing advanced therapies for autoimmune and inflammatory diseases. Akari’s lead asset, investigational nomacopan, is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. The company is conducting pre-clinical research for its lead product candidate, long-acting PAS-nomacopan in geographic atrophy (GA). For more information about Akari, please visit akaritx.com.
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