Akari Therapeutics announces Phase 2 data from BP patients
Akari Therapeutics announced initial Phase 2 clinical data from the first three of bullous pemphigoid, or BP, patients in an ongoing clinical trial. Bullous pemphigoid is an orphan inflammatory skin disease currently treated primarily with steroids and immunosuppressants which bring with them well known side effects. Treatment response and steroid potency varies significantly based on the severity of the disease, although flares and relapses frequently occur. In patients with bullous pemphigoid there is evidence that both terminal complement activation, or C5, and the lipid mediator leukotriene B4, or LTB4, have a central role in driving the disease. Ex vivo data, from a recent study at Lubeck University, in BP patients showed a pronounced accumulation of LTB4 and C5 and its activation products in the inflamed skin of bullous pemphigoid disease patients. The Phase 2 trial for up to nine mild-to-moderate bullous pemphigoid patients is a six-week open-label single-arm study evaluating safety and with the main efficacy measure the Bullous Pemphigoid Disease Area Index, or BPDAI, a frequently used evaluation of the extent and severity of the disease. Initial results from the first three patients showed that Nomacopan, dosed daily subcutaneously, was well tolerated in three elderly patients and that there were no drug-related adverse events. Prior to treatment with Nomacopan, two out of the three patients were already on topical corticosteroids while a third was naive to steroid treatment. Steroids were reduced at weekly intervals so that by day 21 both patients were only treated with Nomacopan. In the 7-11-day period prior to initiation on Nomacopan, the two patients on steroids showed either no or minor improvement in their BPDAI global score and no improvement in blisters. By Day 7, 21 and 42 of treatment with Nomacopan, the BPDAI global score fell by a mean of 31%, 45% and 52%, respectively. By Day 7, 21 and day 42 of treatment with Nomacopan, blisters/erosions dropped by a mean of 45%, 75% and 87%, respectively.