KalVista Pharmaceuticals Reports Phase 2 Clinical Trial Results in Patients with Diabetic Macular Edema

– KVD001 Does Not Meet Primary Endpoint –

– Pre-Planned Analyses Show Clinical Benefit on Vision –

– KVD001 Generally Safe and Well Tolerated –

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced results of the Phase 2 clinical trial evaluating the use of KVD001 in patients with diabetic macular edema (DME).

The KVD001 Phase 2 clinical trial study was designed to evaluate patients who were poor responders to previous treatment with anti-VEGF therapy. The primary efficacy endpoint in the trial was change in best corrected visual acuity (BCVA) at 16 weeks compared to sham. The 6μg dose showed a difference of +2.6 letters versus sham, which was not statistically significant (p=0.223), and the 3μg dose showed a difference of +1.5 letters (p=0.465). No significant differences were observed in the secondary endpoints of central subfield thickness (CST) or the diabetic retinopathy severity scale (DRSS). KVD001 was generally safe and well tolerated with no drug-related serious adverse events.

“This was the first study to evaluate the efficacy of a plasma kallikrein inhibitor in DME,” said Andrew Crockett, Chief Executive Officer of KalVista. “There is a significant population of DME patients who do not respond sufficiently to anti-VEGF therapies, and we want to express our gratitude to these patients as well as the healthcare providers and others who participated. Although the study did not meet the primary endpoint, KVD001 demonstrated what we believe is an important dose responsive clinical benefit on vision in the overall population. In addition, we identified a substantial proportion of patients who experienced a more robust response to treatment, that we believe warrants further study. These data and the safety profile also support continued evaluation of oral plasma kallikrein inhibitors as a treatment for DME.”

In the overall study population, KVD001 demonstrated a protection against vision loss. In the sham treated group 54.5% of patients experienced a reduction in vision compared to 32.5% in the 6μg dose (p=0.042). The study also included a pre-specified subgroup analysis investigating the impact of baseline visual acuity on response. After excluding those patients with the most severe vision loss (visual acuity of