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Akari Therapeutics' stock flies after 'positive' FDA meeting for pediatric thrombotic microangiopathy

Pivotal clinical trial for Coversin in pediatric patients with HSCT-TMA expected to start in fourth quarter 2019 following FDA feedback

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New York-based Akari Therapeutics is a clinical-stage biopharmaceutical company, focusing on the development and commercialization of treatments for a range of rare and orphan autoimmune and inflammatory diseases

Akari Therapeutics PLC (NASDAQ:AKTX) shares rocket Thursday after the company said it plans to start trials in European and US pediatric patients this year for its treatment of pediatric thrombotic microangiopathy (TMA), defined by low blood platelets, and organ damage due to the formation of microscopic blood clots in capillaries and arteries.

Investors sent shares of the company up 25.76% to $7.42 in midday trading.

New York-based Akari Therapeutics is a clinical-stage biopharmaceutical company, focusing on the development and commercialization of treatments for a range of rare and orphan autoimmune and inflammatory diseases.

READ: Neovasc announces public offering, aims to raise almost US$4.25M

Its lead drug candidate is Coversin, a second-generation inhibitor that is in Phase II clinical trial for the treatment of autoimmune and inflammatory diseases.

Akari said it had a “successful,” pre-investigational new drug (IND) meeting with the Food and Drug Administration (FDA) regarding its pivotal clinical trial program for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

HSCT-TMA is an orphan condition with an estimated fatality rate of more than 80% in children

A framework for the trial design was agreed with the FDA. 

“Akari plans to commence a trial in European and US pediatric HSCT-TMA patients in the fourth quarter of 2019,” said Akari CEO Clive Richardson in a statement. “We see HSCT-TMA as a gateway indication into a range of other poorly treated orphan TMAs, and are enthusiastic about the potential of Coversin to offer an improved standard of care for patients with these rare and usually fatal conditions.”

—(This story was updated to reflect share price)— 

Contact Uttara Choudhury at [email protected]

Follow her on Twitter@UttaraProactive 

 

 

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