Akari Therapeutics receives “positive and constructive” pre- Investigational New Drug for PAS-nomacopan

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Akari Therapeutics announced that the company has received “positive and constructive” pre-Investigational New Drug Application (IND) feedback from the US Food and Drug Administration (FDA) providing additional clarity on the company’s planned IND for PAS-nomacopan for intravitreal treatment of geographic atrophy (GA).

The company noted in a news release¹ that a full-scale batch of drug substance was recently successfully manufactured and released under applicable Good Manufacturing Practices (GMP) conditions by their manufacturing partner, Wacker Biotech GmbH. The batch is planned to be used for IND-enabling studies as well as initial clinical development.

Miles Nunn, Chief Scientific Officer of Akari Therapeutics stated, “We thank the FDA for its positive and constructive feedback. The [pre-IND] 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.”

The feedback from the FDA, as well as the production of GMP materials, enables a clear path forward to submitting an IND, according to the company.

PAS-nomacopan is a long-acting bispecific inhibitor of C5 and leukotriene B4 (LTB4). The company stated that it believes it has the potential for longer dose intervals between intravitreous injections, as well as a potential reduction of the choroidal neovascularization (CNV) risk that is associated with approved inhibitors.¹

Samir R Patel, MD, Interim CEO of Akari stated, “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.”

Akari Therapeutics stated it intends to submit the IND for PAS-nomacopan in 2025.¹

References:

1. Akari Therapeutics Receives Positive and Constructive Pre-IND Feedback from US FDA for PAS-nomacopan in Treatment of Geographic Atrophy. Akari Therapeutics. Press Release. Released August 19, 2024. Accessed August 19, 2024. https://investor.akaritx.com/news-releases/news-release-details/akari-therapeutics-receives-positive-and-constructive-pre-ind