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news.Lipid-like therapeutics pioneer D-Pharm Ltd has started enrolling patients for a confirmatory phase IIb study of its novel neuroprotective drug, DP-b99, in acute stroke.
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The international trial is designed to reconfirm the efficacy and beneficial effect of DP-b99 previously observed in stroke patients, as well as to strengthen and extend the safety data obtained from the phase IIa study.
The study will recruit 150 acute stroke patients at centers in Europe and Israel. DP-b99 will be administered intravenously over four days with the first administration up to nine hours following stroke onset. The patient group will be stratified into those treated within six and within nine hours following stroke onset, hence the study is expected to more clearly define the optimal therapeutic window for the drug.
DP-b99, designed and developed by D-Pharm, is a unique neuroprotective drug that addresses the array of damaging processes occurring in brains of stroke patients. This includes protection against acute zinc and calcium mediated cell damage, as well as mitigation of neuro-inflammation and edema.
In earlier phase I and II clinical trials, DP-b99 has proven to be exceptionally safe both in healthy young and elderly volunteers and in stroke patients.
“There have been numerous failures in stroke drug development, mainly owing to safety issues, hence it was a major achievement to find from our first phase II clinical trial that DP-b99 can be used safely in stroke patients” said Dr Itzchak Angel, D-Pharm’s vice president for R&D.
He further commented, “Following the encouraging efficacy results in our phase IIa trial, we are looking forward to seeing these confirmed in a larger patient population; this will enable us to move forward with confidence to phase III.”