DiaMedica Announces Positive Results in Top-Line Data From the Phase II ReMEDy Acute Ischemic Stroke Study - Seite 2

Due to the large volume of participants receiving mechanical thrombectomy prior to enrollment in the study (48%) and a disproportionate distribution between the active treatment and placebo groups, DM199 did not produce a therapeutic effect in the overall study analysis.

When participants treated with mechanical thrombectomy are excluded from the study data set, representing the group of participants most closely aligned with the target treatment population for DM199 noted above, a positive therapeutic effect was demonstrated. As shown in the table below, when evaluating the participants treated with DM199 (n=25) vs. palliative therapies and/or tPA (n=21), the results showed that 36% of participants receiving DM199 progressed to a full or nearly full recovery at 90 days (NIHSS: 0-1), compared to 14% of participants in the placebo group. This represents a 22% increase in the proportion of participants achieving a full or nearly full recovery. Additionally, subject deaths decreased from 24% in the placebo group to 12% in the active therapy group, a 50% reduction.

	DM199 vs. Palliative Therapies and/or tPA
	NIHSS Outcomes at 90 Days
	0-1	2-8	≥ 9	Death
Placebo (n=21)	14%	57%	5%	24%
DM199 (n=25)	36%	36%	16%	12%

In addition, in the evaluable participants (n=91), a significant reduction in the number of participants with severe recurrent stroke was noted in the active treatment group: 1 (2%) patient treated with DM199 vs. 7 (16%) on placebo (p=0.028), with 4 of the 7 on placebo resulting in participant death.

Further, in reviewing evaluable participants (n=91), improvements in the following biomarkers were observed in participants treated with DM199, which the Company believes are consistent with the DM199 mechanism of action:

• Increased nitric oxide (+105%) and prostaglandin E2 (+54%) were observed at day 22 vs baseline (p<0.05). Placebo group was not statistically significant vs baseline (p>0.05). These changes noted in the active treatment group did not reach statistical significance compared to placebo.
• Reduction in C-reactive protein (CRP) of (-70%), a blood marker of inflammation, at 90 days. CRP decreased significantly vs. baseline (p<0.05), but was not statistically significant vs. placebo. The change in the placebo group was not statistically significant vs. baseline (p>0.05).
• Reduction in elevated glucose levels in participants with type 2 diabetes, as defined by a blood glucose level >7 mmol/L (n=14), an average decrease of 1.9 mmol/L (p=0.06) in blood glucose levels of participants on active therapy was observed at day 22. In comparison, participants in the placebo group (n=16) showed an average increase of 0.08 mmol/L (p=0.94) at day 22.

DiaMedica is also developing DM199 for the treatment of chronic kidney disease (CKD). Accordingly, changes in the estimated glomerular filtration rate (eGFR), a measure of kidney function, were analyzed in participants with eGFR <70 mL/Min/1.73² at baseline, which indicates the presence of CKD. Participants receiving DM199 exhibited a marked increase in eGFR at days 22 (last dose) and 56 (34 days post-treatment), as shown in the table below. Further the Company noted that eGFR at day 22 increased by at least 2 mL/Min in 77% of DM199 participants compared to 20% in placebo (p=0.007). DM199 is currently being evaluated in the REDUX phase II study for CKD.