Poland and U.K. Regulatory Authorities – URPL and MHRA – Approve Use of New, Higher-Yielding Manufacturing Process for Nomacopan in Pivotal Clinical Study

Rhea-AI Summary

Akari Therapeutics (Nasdaq: AKTX) has announced that regulatory agencies in Poland and the U.K. approved amendments to its Investigational Medicinal Product Dossier and Clinical Trial Authorisation for the third-generation manufacturing process of nomacopan, which significantly boosts its yield by at least 5-fold. This enhancement is set to improve cost efficiencies as Akari moves into pivotal Part B of the Phase 3 clinical trial for nomacopan, targeting pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). The trial includes sites in Poland, the U.K., and the U.S.

Positive

• Regulatory approval for third-generation manufacturing process enhances production efficiency.
• Final yield of nomacopan increases by at least 5-fold, improving cost efficiencies.
• Advancement to pivotal Part B of Phase 3 clinical trial for nomacopan for pediatric HSCT-TMA.

Negative

• None.

• Third generation drug substance manufacturing process increases the final yield of nomacopan by at least 5-fold, improving cost efficiencies in the continuing Phase 3 clinical trial of nomacopan in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) advancing to pivotal Part B later this year
  

NEW YORK and LONDON, March 29, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced  regulatory authorities in Poland (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products/URPL) and the U.K. (Medicines & Healthcare products Regulatory Agency/MHRA) have approved amendments to the company’s Investigational Medicinal Product Dossier (IMPD) and Clinical Trial Authorisation (CTA), respectively, for clinical use of the third-generation drug substance manufacturing process that increases the final yield of nomacopan by at least 5-fold. Nomacopan is an investigational bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4) currently in Phase 3 clinical trials for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

“The clearance by regulators in the U.K. and Poland of Akari’s newer, enhanced manufacturing process for nomacopan is another important step forward in our progress toward the pivotal Part B in our clinical trials in pediatric HSCT-TMA,” said Rachelle Jacques, President and Chief Executive Officer of Akari Therapeutics.

The Phase 3 study of nomacopan in pediatric HSCT-TMA includes clinical trial sites in Poland, the U.K. and U.S.

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. Akari’s pipeline includes a Phase 3 clinical trial program investigating nomacopan for severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Akari has been granted Orphan Drug, Fast Track and Rare Pediatric Disease designations from the FDA for nomacopan for the treatment of pediatric HSCT-TMA. Akari’s pipeline also includes a clinical program developing nomacopan for adult HSCT-TMA and pre-clinical research of long-acting PAS-nomacopan in geographic atrophy (GA). For more information about Akari, please visit akaritx.com.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies, and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies, and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result there; difficulties enrolling patients in our clinical trials; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected risks associated with the impact of the COVID-19 pandemic; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

For more information

Investor Contact:
Mike Moyer
LifeSci Advisors
(617) 308-4306
mmoyer@lifesciadvisors.com

Media Contact:
Eliza Schleifstein
Schleifstein PR 
(917) 763-8106
eliza@schleifsteinpr.com

FAQ

What is nomacopan and its significance for AKTX?

Nomacopan is an investigational bispecific inhibitor for treating pediatric HSCT-TMA, currently in Phase 3 trials.

What regulatory approvals has Akari Therapeutics received?

Akari received approvals from Poland and the U.K. for its revised manufacturing process of nomacopan.

What does the 5-fold increase in yield mean for AKTX?

The 5-fold increase in yield enhances production efficiency and could reduce costs for Akari's clinical trial of nomacopan.

When will the pivotal Part B of the Phase 3 trial for nomacopan begin?

The pivotal Part B of the Phase 3 trial for nomacopan is expected to commence later this year.