Akari Therapeutics PLC (NASDAQ: AKTX) shares were surging Tuesday, breaking above the $4 barrier for the first time in about a month.
The microcap biotech — which focuses on therapies for autoimmune and inflammatory diseases — announced positive Phase 2 results for nomacopan, or Coversin, which is being evaluated for bullous pemphigoid, a severe inflammatory skin disease.
Akari is also evaluating Coversin for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy.
The midstage trial studied up to nine mild-to-moderate bullous pemphigoid patients in a six-week, open-label, single-arm study that evaluated safety and efficacy. They results measured using the bullous pemphigoid disease area index, or BPDAI, which measures both the extent and severity of the disease.
Initial results from the first three patients showed that nomacopan was well-tolerated in elderly patients with daily subcutaneous doses, with no drug-related adverse events.
The BPDAI global score by days seven, 21 and 42 of treatment with nomacopan fell by a mean of 31 percent, 45 percent and 52 percent, respectively. In the same duration, blisters/erosions dropped by a mean of 45 percent, 75 percent and 87 percent, respectively.
Why It's Important
Bullous pemphigoid is primarily treated with steroids and immunosuppressants, both of which have side effects.
"The initial Phase II data in BP patients treated with Nomacopan (Coversin) is very encouraging, indicating that BP can potentially be resolved without the adverse issues caused by current steroidal treatments," Professor Detlef Zillikens and Professor Christian Sadick, lead investigators of the study, said in a statement.
Following the positive data, Akari said it plans to expand the trial to include additional severe patients by way of an amendment.
"We believe this promising data helps validate our strategy of focusing on those poorly treated orphan diseases where both C5 and LTB4 are implicated," the company said.
Akari shares were jumping 30.75 percent to $4.38 at the time of publication Tuesday.
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