Date: 2017-01-03
Type of information: Clinical trial authorization
phase: 2
Announcement: clinical trial authorization
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 (PNH)
Therapeutic area: Rare diseases - Immunological diseases
Country: The Netherlands, UK, USA
Trial details:
Latest
news: * On January 3, 2017, Akari Therapeutics announced that the FDA has allowed on December 29th, 2016, its Investigational New Drug Application (IND) for the clinical development of Coversin™ in patients with paroxysmal nocturnal hemoglobinuria. The FDA's allowance of the IND permits the Company to expand its clinical program for the development of Coversin in PNH to the United States. The Company has one currently treated eculizumab resistant PNH patient who has been on Coversin for approximately 11 months pursuant to an approved clinical protocol in the Netherlands and plans to open this ongoing Phase II trial of Coversin in eculizumab resistant PNH in the United States. * On July 13, 2016, Akari Therapeutics announced the approval by the UK Medicines & Healthcare products Regulatory Agency (MHRA) to conduct a Phase 2 trial in patients with paroxysmal nocturnal hemoglobinuria (PNH). This Phase 2 open label trial will study Coversin for 90 days in up to 10 patients with PNH who are not receiving any other complement therapy. The primary endpoint of the trial is the reduction in Lactate Dehydrogenase (LDH), an important blood marker of hemolysis, at day 28. The trial will also explore other endpoints including complement inhibition, LDH throughout the 90 days, as well as measurements of quality of life. At the end of the trial, patients will have the option to continue therapy with Coversin as part of a long term safety study.
The objectives of this clinical trial are to determine the safety and efficacy of Coversin in patients with proven resistance to eculizumab due to complement C5 polymorphisms. These patients are entered into an open label protocol where safety and efficacy are measured on an ongoing basis. Data from patients in this trial will be presented at future scientific forums. Akari also has an ongoing Phase II trial in Europe in patients with PNH without polymorphism with data expected in the first quarter of 2017.
