Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
After filing patents on a decades-old antipsychotic, Aneurotech BV is laying plans for a U.S. phase IIIb trial of the drug as an adjunctive therapy in major depressive disorder. The study will assess the effects of ANT-01, a low dose of pipamperone, a selective antagonist of both the serotonin 5-HT2A and D4 dopamine receptors, which has been on the market in some countries in Europe and elsewhere for more than 40 years.
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