FDA investigational new drug application (IND) now open
Clinical sites expected to open for recruitment mid-2021
NEW YORK, NY, USA and LONDON, UK I April 12, 2021 I Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and leukotriene systems are implicated, announces that an IND is now open with the U.S. Food and Drug Administration (FDA) for its multicenter Phase III study with nomacopan for the treatment of moderate and severe BP, allowing clinical sites to open mid-2021, subject to the ongoing impact of COVID related restrictions. Akari has been granted orphan drug designation for nomacopan for the treatment of BP by both the FDA and the European Medicines Agency (EMA).
“With the BP IND now open we look forward to starting the pivotal Phase III study of nomacopan in patients with this severe dermatological condition, for which there is no specific approved treatment in the U.S. or Europe,” commented Clive Richardson, Chief Executive Officer of Akari Therapeutics. “Success in BP could also open up a range of other severe dermatological conditions for treatment with nomacopan where C5 and LTB4 are implicated including hidradenitis suppurativa, epidermolysis bullosa acquisita and mucous membrane pemphigoid.”
BP may last several years in the absence of treatment, has a tendency to relapse and is most common in the elderly. It is primarily treated with potent oral steroids for six months or more which bring with them deleterious side effects and a three-fold or larger increase in mortality. The prevalence of BP is estimated to be approximately 120,000 patients in U.S. and EU with moderate and severe patients making up around three quarters of the patient population.
In patients with BP there is evidence that nomacopan’s ability to inhibit C5 and LTB4 gives it a unique potential therapeutic advantage which is upstream of other approaches (such as cytokine inhibitors) that are being investigated for treatment of BP. In the Phase II nomacopan study, patients with BP had elevated levels of LTB4 in their serum and in addition both C5 and LTB4 levels are elevated in blister fluid from BP patients, illustrating the local activation of both these inflammatory pathways. Moreover, in a pre-clinical model (Sezin et al 2019) the absolute body surface area affected by blisters was reduced by approximately 50% by inhibiting LTB4 alone but by approximately 80% by inhibiting both LTB4 and C5.
Akari’s pivotal Phase III trial design, which is a randomized placebo-controlled study with nomacopan in patients with moderate to severe BP with a primary endpoint of disease remission on minimal oral corticosteroids was based on the Company’s successful end-of-Phase II meetings held last year with both the FDA and the EMA.
About Akari Therapeutics
Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari’s lead drug candidate, Nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically binds to and inhibits leukotriene B4 (LTB4) activity.
SOURCE: Akari Therapeutics
Post Views: 39
FDA investigational new drug application (IND) now open
Clinical sites expected to open for recruitment mid-2021
NEW YORK, NY, USA and LONDON, UK I April 12, 2021 I Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and leukotriene systems are implicated, announces that an IND is now open with the U.S. Food and Drug Administration (FDA) for its multicenter Phase III study with nomacopan for the treatment of moderate and severe BP, allowing clinical sites to open mid-2021, subject to the ongoing impact of COVID related restrictions. Akari has been granted orphan drug designation for nomacopan for the treatment of BP by both the FDA and the European Medicines Agency (EMA).
“With the BP IND now open we look forward to starting the pivotal Phase III study of nomacopan in patients with this severe dermatological condition, for which there is no specific approved treatment in the U.S. or Europe,” commented Clive Richardson, Chief Executive Officer of Akari Therapeutics. “Success in BP could also open up a range of other severe dermatological conditions for treatment with nomacopan where C5 and LTB4 are implicated including hidradenitis suppurativa, epidermolysis bullosa acquisita and mucous membrane pemphigoid.”
BP may last several years in the absence of treatment, has a tendency to relapse and is most common in the elderly. It is primarily treated with potent oral steroids for six months or more which bring with them deleterious side effects and a three-fold or larger increase in mortality. The prevalence of BP is estimated to be approximately 120,000 patients in U.S. and EU with moderate and severe patients making up around three quarters of the patient population.
In patients with BP there is evidence that nomacopan’s ability to inhibit C5 and LTB4 gives it a unique potential therapeutic advantage which is upstream of other approaches (such as cytokine inhibitors) that are being investigated for treatment of BP. In the Phase II nomacopan study, patients with BP had elevated levels of LTB4 in their serum and in addition both C5 and LTB4 levels are elevated in blister fluid from BP patients, illustrating the local activation of both these inflammatory pathways. Moreover, in a pre-clinical model (Sezin et al 2019) the absolute body surface area affected by blisters was reduced by approximately 50% by inhibiting LTB4 alone but by approximately 80% by inhibiting both LTB4 and C5.
Akari’s pivotal Phase III trial design, which is a randomized placebo-controlled study with nomacopan in patients with moderate to severe BP with a primary endpoint of disease remission on minimal oral corticosteroids was based on the Company’s successful end-of-Phase II meetings held last year with both the FDA and the EMA.
About Akari Therapeutics
Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari’s lead drug candidate, Nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically binds to and inhibits leukotriene B4 (LTB4) activity.
SOURCE: Akari Therapeutics
Post Views: 39
