Remedy Pharmaceuticals Reports Additional Results From Phase 2 CNS-Related Edema Study of CIRARA™

Remedy Pharmaceuticals announced additional efficacy data from its Phase 2 trial of CIRARA™ for preventing edema (brain swelling) in patients with large hemispheric stroke.
According to the news release:

Adjudicated neurological mortality was reduced from 25% in placebo to 7% in CIRARA-treated patients (p=0.03), a more than three-fold reduction in mortality, and death from edema (swelling) was reduced from 22% in placebo to 2% in CIRARA-treated patient (p=0.008), or a ten-fold decrease.

In a pre-specified “shift analysis”, there was a trend towards improved 6-month functional (modified Rankin Scale or mRS) scores (p=0.13). The sizable reduction in mortality exhibited at 90 days remained at six months (20% in placebo versus 39% in the CIRARA group, p=0.06)

In patients 70 and younger, 90-day functional outcomes were statistically significantly improved across the board (p=0.048), and 90-day mortality was dramatically reduced from 33% in the placebo group to 12% in the CIRARA group (p=0.03). This difference persisted at six months (37% vs. 14%, p=0.04).

Sven Jacobson, CEO of Remedy Pharmaceuticals, said:

This exciting six-month data shows a continued reduction in mortality and improvement in functional scores, the adjudicated mortality data further confirms the mechanism of action of CIRARA, and the robust signal in patients 70 and under suggests an even larger effect in younger patients. This additional data is very helpful as we move forward with the design of our planned Phase 3 trial.

Click here to view the full press release.