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, Aug. 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.
This communication includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding Akari’s anticipated clinical development activities.
These statements are based on Akari’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: our need for additional capital; Akari’s ability to consummate our planned merger with Peak Bio and our ability to successfully integrate operations with Peak Bio following the merger, if consummated; recent adjustments to Akari’s operating plans, including its pipeline prioritization; Akari’s ability to complete a divestiture or secure a strategic partnership for Nomacopan; Akari’s ability to successfully develop or commercialize Akari’s product candidates; Akari’s, or its collaborators’ abilities to continue to conduct current and future developmental, preclinical and clinical programs; the extent to which the results from the research and development programs conducted by Akari and/or its respective collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of Akari’s product candidates, and the impact of studies (whether conducted by Akari or others and whether mandated or voluntary) on any of the foregoing; unexpected breaches or terminations with respect to Akari’s material contracts or arrangements; risks related to competition for Akari’s product candidates; risks related to any loss of Akari’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for Akari product candidates, the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by Akari, or its collaborators or licensees; potential exposure to legal proceedings and investigations; risks related to changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing, development or commercialization of any of Akari’s product candidates; unexpected increase in costs and expenses with respect to the potential merger or Akari’s business or operations; and risks and uncertainties related to epidemics, pandemics or other public health crises and their impact on Akari’s business, operations, supply chain, patient enrollment and retention, preclinical and clinical trials, strategy, goals and anticipated milestones. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the proposed transaction or any other transaction described above will in fact be consummated in the manner described or at all. A more complete description of these and other material risks can be found in Akari’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including Akari’s Annual Report on 10-K, for the year ended December 31, 2023, subsequent periodic reports, and other documents that may be filed from time to time with the SEC.
Any forward-looking statements speak only as of the date of this communication and are made based on the current beliefs and judgments of Akari’s management, and the reader is cautioned not to rely on any forward-looking statements made by Akari. Unless required by law, Akari is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this document, including without limitation any financial projection or guidance, whether as a result of new information, future events or otherwise.
