KalVista Shares Sink On Failed Mid-Stage Study Of Diabetic Macular Edema Drug

Shares of thinly-traded micro-cap biotech Kalvista Pharmaceuticals Inc KALV are seen moving to the downside Monday.

What Happened

Massachusetts-based KalVista, which focuses on developing small molecule protease inhibitors, said a Phase 2 study that evaluated its KVD001 in patients with diabetic macular edema, who were poor responders to previous treatment with anti-VEGF therapy, did not meet the primary and secondary endpoints.

KVD001 is a small molecule plasma kallikrein inhibitor administered by intravitreal injection.

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KalVista noted the 6 microgram dose showed a difference of +2.6 letters versus sham in best corrected visual acuity, or BCVA, at 16 weeks, which was not statistically significant. The change in BCVA at 16 weeks versus sham is the primary endpoint. Sham injection is the injection of a placebo or agent that stimulates a drug being administered in a clinical trial.

The 3 microgram does also did not showed statistically significant difference relative to sham in BCVA at 16 weeks. Also, KVD001 showed no significant differences in the secondary endpoints of central subfield thickness or the diabetic retinopathy severity scale.

However, the pipeline asset was found to be generally safe and well tolerated with no drug-related serious adverse events.

"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," said CEO Andrew Crockett. "These data and the safety profile also support continued evaluation of oral plasma kallikrein inhibitors as a treatment for DME."

Why It's Important

KalVista has an option licensing agreement with pharma giant Merck & Co., Inc. MRK with regard to KVD001. According to the agreement, KalVista would provide Merck a set of clinical and other data after which the latter will decide within a specified period whether to exercise the option.

If Merck chooses to exercise the option, KalVista stands to receive payment as well future potential milestone and royalty payments.

KalVista shares were sliding 16% to $12 at time of publication.