fiercebiotechDecember 28, 2018
Tag: DiaMedica , IPO , stroke trial , CKD
DiaMedica Therapeutics has wrapped up its IPO. The offering gives DiaMedica the cash to take its lead candidate through phase 2 trials in acute ischemic stroke (AIS) and chronic kidney disease (CKD).
Minneapolis-based DiaMedica is focused on the development of DM199, a recombinant form of human tissue kallikrein-1 (KLK1). AIS and CKD patients tend to have low levels of KLK1, and given the endogenous serine proteases' role in vasoregulation, DiaMedica thinks giving them a boost could improve blood flow to the brain and kidneys.
DiaMedica’s thesis is underpinned by research into the effects of KLK1. Forms of the protease derived from human urine and porcine pancreas are already sold in Asia as treatments for AIS, CKD and other diseases. As DiaMedica sees it, only regulations are stopping these forms from coming to market in the U.S. DiaMedica thinks at least five other companies have tried and failed to develop recombinant KLK1, leaving its DM199 as the sole synthetic version in development.
Convinced by the efficacy of KLK1, DiaMedica is working to get its synthetic version of the protein to market in the West. The candidate, DM199, has been through early-phase tests in healthy volunteers and Type 2 diabetics and is now advancing through the clinic in AIS and CKD.
With a phase 2 trial in AIS underway and a phase 1b in CKD in the works, DiaMedica filed for an IPO. The listing has resulted in the sale of 4.1 million shares at $4 a piece, the bottom end of the range set out in a filing with the SEC late last month. When DiaMedica expected to net, not gross, $16.4 million, it said the IPO would fund phase 2 trials in AIS and CKD to completion.
Enrollment in the phase 2 AIS trial, which will recruit up to 100 patients, is underway. DiaMedica plans to file an IND for a phase 1b study in CKD by the end of 2018 and move into phase 2 after that trial reads out next year.
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