Shares of the thinly traded nano-cap biotech DiaMedica Therapeutics Inc DMAC were rallying strongly Thursday.
What Happened
DiaMedica announced positive interim results from a Phase 1b study of its DM199, which is being evaluated for moderate-to-severe chronic kidney disease, or CKD.
DM199 is a synthetic form of human serine protease KLK1, which plays a key role in the regulation of diverse psychologic processes such as blood flow, inflammation, fibrosis, oxidative stress and neurogenesis through an increase in the production of nitric oxide, prostacyclin and other anti-inflammatory mediators.
The interim results of the study, which had 28 evaluable patients, showed the drug was safe and well-tolerated, with no drug-related serious adverse events and a pharmacokinetic profile in CKD subjects similar to that of healthy volunteers.
Pharmacokinetics, safety and tolerability were the primary endpoints of the trial.
The study also showed a dose range that the company believes will restore normal KLK1 levels in CKD patients.
Encouraging early signals in estimated glomerular filtration rate, urinary albumin to creatinine ratio and other markers — a few of the key secondary endpoints along with nitric oxide and prostaglandin E2 — were also observed, DiaMedica said.
What's Next
The favorable interim safety, tolerability and pharmacokinetic data, complemented by pharmacodynamic observations, support the advancement of DM199 to a Phase 2 clinical trial in patients with CKD, according to the biotech.
DiaMedica said it is looking to provide full results of the study in a peer-reviewed publication and/or poster presentation.
DiaMedica shares were up 27.23% at $4.86 at the time of publication Thursday.
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