DiaMedica Therapeutics (DMAC) shares rose as much as 16% in extended trading on Wednesday after the clinical-stage biotechnology company reported encouraging interim results from the phase 1b study from 28 evaluable participants with moderate and severe chronic kidney disease (CKD).
DM199 was observed to be safe and well tolerated with no drug-related serious adverse events, consistent with earlier DM199 studies in healthy volunteers, DiaMedica said in a statement.
The company said that pharmacodynamic results helped identify the dose range for mid-stage studies.
“We’re pleased to report interim results from the Phase Ib study met expectations for the primary endpoints, [pharmacokinetic] PK, safety and tolerability,” the company quoted its chief medical officer Dr. Harry Alcorn as saying in the statement.
“Moreover, although this study was not designed for efficacy testing, it was notable that overall secondary endpoints … showed encouraging early signals.” Dr. Alcorn added.
“Most importantly, we’re encouraged about DM199’s potential as a treatment option to improve the lives of patients with chronic kidney disease,” Dr. Alcorn said.
The company said that it anticipates the mid-stage trial to start later this year, with interim analysis expected in Q4 or Q1.