US rejection knocks Kala off its Stride

Kala Pharmaceuticals will have to wait a bit longer before it can get its dry eye disease candidate KPI-121 to the market. The project received a complete response letter from the FDA, which requested data from Kala’s phase III Stride 3 trial, results of which are expected by the end of the year. The knockback sent Kala’s stock down 10% yesterday, but it cannot have been hugely unexpected as the treatment produced mixed results in two previous pivotal trials, and Kala must have had its own doubts given that it started Stride 3 before the FDA’s verdict. Stride 2 missed one of its co-primary endpoints, ocular discomfort, which is the primary endpoint in Stride 3. Kala hopes that changes to the inclusion/exclusion criteria in Stride 3 could give this study a better chance of success; the group noted on its second-quarter earnings call that patients in Stride 2 had variable levels of symptoms at baseline. Still, the fact that Kala filed KPI-121 before Stride 3 read out could be seen as an effective move by the company, speeding up the whole process and allowing a second submission and approval within six months, analysts suggested. The project’s sales are expected to reach $831m by 2024 according to EvaluatePharma consensus.

Not hitting its Stride: mixed data with KPI-121
Phase III study Results Trial ID
Stride 1 Statistically significant improvements in both the primary sign (conjunctival hyperaemia) and symptom (ocular discomfort severity) endpoints  NCT02813265
Stride 2 Statistical significance only met with primary sign endpoint  (conjunctival hyperaemia) NCT02819284
Stride 3 Data due by the end of 2019 (primary endpoint: ocular discomfort at 2 weeks) NCT03616899

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