DiaMedica Announces Positive Results in Top-Line Data From the Phase II ReMEDy Acute Ischemic Stroke Study - Seite 3

eGFR Mean Δ from Baseline (mL/Min/1.732)

 

Day 22
(Last Dose)

Day 56
(Off Treatment)

Placebo

+0.84
(n=15)

-0.24
(n=12)

DM199

+7.5
(n=13)

+5.8
(n=12)

Group
Difference

+6.6

+6.1

“These findings are consistent with Chinese data on the urine-derived form of KLK1 and provide a signal that recombinant human KLK1 appears safe and may have promise as a new tool for physicians who have limited options for the treatment of patients suffering acute ischemic stroke,” said Professor Bruce Campbell, BMedSc, PhD, FRACP, FAHMS Neurologist, Head of Stroke Department of Neurology at the Royal Melbourne Hospital.

DiaMedica’s President and CEO, Rick Pauls, said: “Very few patients have a treatment option for AIS today. Approximately 10% of patients receive tPA or mechanical thrombectomy and we are developing DM199, with a 24 hour therapeutic treatment window, to significantly expand the proportion of patients who have access to effective and safe treatment.” Mr. Pauls continued, “It’s also very encouraging to see data suggesting that DM199 treatment may mitigate the adverse impact of ischemic stroke on kidney function, a significant but poorly understood comorbidity in many stroke victims.”

The detailed results of the ReMEDy trial has been accepted for E-Poster discussion at the joint European Stroke Organisation and World Stroke Organization Conference (ESO-WSO 2020), to be held in Vienna, Austria on November 7, 2020 and will also be submitted for publication.

DiaMedica intends to request a meeting with the FDA to define the development program leading to a path to commercialization for acute ischemic stroke.

Conference call and webcast information

DiaMedica will host a live conference call and webcast on Thursday May 14, 2020 at 7:00 am Central Time to discuss the top-line phase II data.

Conference Call details:

Date:		Thursday, May 14, 2020
Time: