D-Pharm Posts Phase 2 Trial Results For THR-18 In Stroke

D-Pharm, a clinical stage biopharmaceutical company focused on developing treatments for CNS disorders, posted the first safety results from its Phase 2 clinical study of its drug THR-18 in acute ischemic stroke (AIS) patients treated with tissue plasminogen activator (tPA).

THR-18 is a synthetic therapeutic peptide indicated for the treatment of acute stroke patients. The drug is being developed to reduce or negate the life-threatening effects of tPA treatments in stroke patients. THR-18 is derived from the natural tPA activity inhibitor known as plasminogen activator inhibitor-1 (PAI-1). The drug untangles the clot-dissolving properties of tPA from its harmful non-fibrinolytic effects on the blood vessel wall, including intracranial hemorrhage and brain edema. Though THR-18 acts on tPA activity, it leaves the treatment’s catalytic activity intact.

The placebo controlled, double blind, escalating single-dose Phase 2 study of THR-18 investigated the safety, pharmacokinetics, and pharmacodynamics of the drug in 30 AIS patients treated with tPA. Primary endpoints include the number of patients with intra-cerebral hemorrhage (ICH) and brain edema, as well as clinical stroke outcome.

Results show that those treated with THR-18 experienced no intracranial hemorrhage compared to those who took placebo. The drug also significantly cut the occurrence of brain edema. The company reported that interim results show that THR-18 eased stroke patients’ disabilities while improving their neurological recovery compared to placebo.

Dr. Gilad Rosenberg, D-Pharm's VP of Clinical Development said, “It is certainly encouraging to see the reduced rates of brain swelling and intracranial bleeding in the tPA-treated stroke patients given THR-18, and I look forward to seeing whether these findings translate into less disability and better neurological recovery once the clinical endpoint data become available for the full data set.”

“In spite of the huge unmet need, the majority of stroke patients do not receive treatment with tPA, the only clot-busting drug approved for this indication. Our data add credence to the idea that THR-18 may antagonize the neurotoxic effect of tPA,” said D-Pharm CEO Dr. Alex Kozak. He added that using THR-18 to improve tPA’s profile will address a significantly unmet medical need in stroke patients.

The company reported that it has completed the recruitment of patients for the Phase 2 trial, the results of which buoyed D-Pharm’s shares by more than 16 percent on the Tel Aviv Stock Exchange.