Date: 2016-07-06
Type of information: Results
phase: 1b
Announcement: results
Company: Akari Therapeutics (USA - NY - UK)
Product: coversin (recombinant protein derived from the saliva of the Ornithodoros moubata tick)
Action
mechanism: protein. Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including Paroxysmal Nocturnal Hemoglobinuria, atypical Hemolytic Uremic Syndrome, and Guillain Barré syndrome.
Disease: paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome
Therapeutic area: Rare diseases
Country: UK
Trial details:
Latest
news: * On July 6, 2016, Akari Therapeutics announced positive interim data from the first cohort in its Phase Ib trial which demonstrates maintenance of complement inhibition using once-daily dosing. The Phase Ib trial in normal healthy volunteers is designed to investigate the maintenance dose of subcutaneous coversin needed to maintain complement inhibition on a once daily basis. The company believes near-complete complement inhibition is necessary to maintain adequate control in patients with certain conditions including Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS).
In this double-blind, randomized Phase Ib trial, each cohort of six normal healthy volunteers is given either a loading dose of subcutaneous placebo twice a day for two days followed by five days of a single daily placebo dose (n=2) or, in this first cohort, a loading dose of 30 mg of subcutaneous coversin twice a day for two days followed by five days of a single daily subcutaneous maintenance dose of 30mg (n=4). Data from this first cohort demonstrated that subcutaneous coversin achieved complete complement inhibition (Elisa CH50 < 8 Eq/ml, lower limit of quantification) within the first day, and demonstrated complete complement inhibition at the end of dosing on day seven. To date, there have been no injection site reactions reported in the trial. One volunteer receiving the coversin dose stopped dosing on day three due to a non-serious adverse event possibly related to antibiotics administered for meningitis prophylaxis. The trial is being conducted at Hammersmith Medicines Research Ltd, in London. It is expected that further data from this trial will be presented at future scientific forums.
