DiaMedica Therapeutics reaches 200 patients in pivotal stroke trial
An independent board will review ReMEDy2 in Q1 2027 and may resize the study to as many as 728 participants or stop it for futility.
Adrian Kessler
An interim review of a pivotal stroke trial is within reach after DiaMedica Therapeutics Inc. NASDAQDMAC reported its 200th ReMEDy2 enrolment on Thursday. That represents two-thirds of the minimum 300-patient target, although the final trial size could rise to 728.
The Oct. 22 announcement says an independent monitoring board will review the study after the first 200 participants complete their 90-day follow-up. Recruitment will continue, DiaMedica will remain blinded and the interim analysis is expected in the first quarter of 2027.
DiaMedica is a small clinical-stage drug developer based in Minneapolis, working on stroke and pregnancy complications.
The shares closed at US$8.69 on Nasdaq at 4 p.m. EDT on Oct. 21, according to NASDAQDMAC, before Thursday's announcement.
The Review Can Resize or Stop the Trial
The ClinicalTrials.gov record for NCT05065216 was updated Sept. 14. It describes a randomized, double-blind Phase 2/3 study assigning participants equally to DM199 or placebo. Treatment starts within 24 hours of stroke symptoms and continues for three weeks.
The registry specifies an initial intravenous dose followed by injections under the skin twice weekly through day 21. Both groups receive the same administration schedule, allowing recovery to be compared under blinded treatment assignments.
The primary endpoint is the proportion achieving an excellent functional outcome, defined as a modified Rankin score of zero or one, at day 90. Thursday's announcement provides no treatment-versus-placebo efficacy results or comparative safety data.
DM199, also called rinvecalinase alfa, is a recombinant enzyme intended to improve blood flow around blocked brain vessels. Its safety and effectiveness for stroke remain unestablished.
The monitoring board will assess whether to resize the trial to preserve statistical power or stop it for futility. If it continues, enrolment will range from 300 to 728 under the predetermined statistical plan.
The announced count leaves at least another 100 participants to recruit if the study continues. At the maximum permitted size, another 528 would be needed, so the interim decision will establish the remaining recruitment requirement.
"ReMEDy2 was designed with the potential to support registration if successful," DiaMedica chief executive Rick Pauls said in the release.
DiaMedica's trial information page says the FDA granted DM199 Fast Track designation in September 2021. Thursday's announcement provides no FDA assessment of whether the adaptive design would be sufficient to support approval.
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Established Treatments Define the Comparison
Roche Holding AG SWXROP OTCMKTSRHHBY is an established drug supplier through Genentech, which announced FDA approval of TNKase for adult acute ischemic stroke on March 3, 2025. Its release recommends starting the clot-dissolving treatment within three hours of symptoms.
In devices, Stryker Corporation NYSESYK lists its Trevo NXT ProVue Retriever for thrombectomy. ReMEDy2 excludes participants who received mechanical thrombectomy or are otherwise eligible for it, while allowing selected patients with persistent neurological deficits after clot-dissolving treatment.
For sector context, the State Street SPDR S&P Biotech ETF NYSEARCAXBI was quoted at US$152.78 at 8 p.m. EDT on Oct. 21.
DiaMedica reported US$43.5 million in cash, cash equivalents and short-term investments at June 30 in its Aug. 10 financial update. Management projected funding for planned studies and operations through 2027, based on its current plans. That forecast preceded the interim board's determination of the final recruitment requirement.
The registry still lists December 2026 as estimated trial completion, but Thursday's announcement schedules only the interim analysis and gives no final readout date.
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The next scheduled catalyst is the first-quarter 2027 interim analysis. It will determine whether ReMEDy2 stops for futility or continues, and how many participants the study ultimately requires.
