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 –
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
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 <55 letters at baseline), the remaining 70% of the total patient population showed a difference in BCVA compared to sham of 4.9 letters (p=0.056) at the 6μg dose.
“This trial studied a challenging DME patient population with significant persistent vision loss despite prior therapies,” said
KVD001 is a small molecule plasma kallikrein inhibitor administered by intravitreal injection. The Phase 2 trial consisted of 129 patients who had previously been treated with anti-VEGF therapy, and still had significant edema and reduced visual acuity. The sham-controlled, double-masked clinical trial evaluated two dose levels of KVD001, 3μg and 6μg. Four intravitreal injections or sham were administered over three months with a three month follow up period. The study was conducted at 38 sites in
KVD001 is subject to an option agreement with
A summary presentation of the KVD001 data findings has been posted to the investors section of the KalVista website, and will be available for the next 30 days.
For more information, please visit www.kalvista.com.
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway, potential future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on
KalVista Pharmaceuticals, Inc.
Senior Director, Corporate Communications & Investor Relations