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July 7, 2021

LoA Update: Akari’s Phase III paroxysmal nocturnal hemoglobinuria asset has six-point fall in regulatory approval chances after trial termination

Akari Therapeutics’ rVA576 (Coversin) in paroxysmal nocturnal hemoglobinuria (PNH) saw its Likelihood of Approval (LoA) dip 6 points to 43% after its Phase III trial was terminated.

By William Newton

Akari Therapeutics’ rVA576 (Coversin) in paroxysmal nocturnal hemoglobinuria (PNH) saw its Likelihood of Approval (LoA) dip 6 points to 43% after its Phase III trial was terminated. The LoA score change occurred on 30 June after its ClincalTrials.gov listing (NCT03829449) was updated on 22 June.

The 15-patient Phase III CONSERVE trial’s listing states that the termination was a business decision and not related to any efficacy, safety, or clinical concerns. CONSERVE was designed as a long-term safety and efficacy surveillance study of Coversin, recruiting patients who have previously received the drug. Coversin is a complement C5 inhibitor with anti-inflammatory properties.

LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. It is calculated by compounding the Phase Transition Success Rate (PTSR) at each stage the drug is yet to progress through. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

Akari has a market cap of $68.6m.

William Newton is a Healthcare Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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