Shares in biotech BioCryst Pharmaceuticals Inc (NASDAQ:BCRX) tanked Tuesday as investors were turned off by Phase 3 trial results of its lead candidate to prevent hereditary heart attacks.
The trial of the once-daily compound BCX7353 achieved its primary endpoint for both dose levels of 110 mg and 150 mg, the firm said in a statement, with the 150 mg dose reducing the attack rate in hereditary angioedema (HAE) patients by 44% compared to placebo.
But, reportedly, the findings fell short of those seen in trials of Takeda’s (NYSE:TAK) Takhzyro product (lanadelimab) in its Phase 3 study, which was approved in the USA in August 2018 and in Europe three months later.
Shares in New York plunged nearly 48% to stand at $3.87.
Reduction in rates
Trial patients receiving 150 mg to 300 mg of the Takeda drug experienced reductions in HAE attack rates of between 76 and 87%.
At the BioCryst trial patients with the 150 mg dose with a baseline attack rate of less than two attacks a month, the BioCryst drug reduced the attack rate by 66% compared to placebo.
Half of the patients receiving 150 mg of the drug had a greater than or equal to 70% reduction in their HAE attack rate compared to baseline, compared to 15% of placebo patients.
"With successful results from APeX-2, BioCryst is committed to making it easy for HAE patients around the world to access this potentially life-changing oral therapy, and we believe BCX7353 is positioned to become a front-line therapy option,” said Jon Stonehouse, CEO.
He added that the findings of the trial supported the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), which the company plans to submit in the fourth quarter of 2019 along with a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first quarter of 2020.
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