Thinly traded micro cap KalVista Pharmaceuticals (NASDAQ:KALV) slumps 20% premarket on average volume in reaction to unsuccessful results from a Phase 2 clinical trial evaluating KVD001 in diabetic macular edema (DME) patients who failed to respond adequately to previous anti-VEGF therapy.
KVD001, a small molecule plasma kallikrein inhibitor administered via intravitreal injection, failed to sufficiently separate from sham (placebo) as measured by best corrected visual acuity (BCVA) at week 16, the primary endpoint. Specifically, the relative effect of KVD001 on BCVA was +1.5 letters for the 3μg dose (p=0.465) and +2.6 letters (p=0.223) for the 6μg dose, both well short of statistical significance. No statistically valid differences were noted in key secondary endpoints either.
On a positive note, KVD001 showed protection against vision loss. 32.5% of participants in the treatment group experienced a reduction in vision compared to 54.5% in the sham group (p=0.042).
Merck (NYSE:MRK) has an option to acquire the rights to KVD001 under a 2017 agreement.
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