Reviewing BCX9930 Safety Data reported by the company on Nov 3, 2021 | BCRX Message Board Posts


BioCryst Pharmaceuticals Inc.

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Msg  12821 of 12828  at  4/13/2022 10:42:25 AM  by

moegrabbedmythumb


Reviewing BCX9930 Safety Data reported by the company on Nov 3, 2021

 

A Long Term Safety Study of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

• 200 participants enrolled

• As of end of September 2021, average dosing duration now exceeds 11 months, with the longest duration 19 months

• Data continues to support safety and tolerability of BCX9930, with no safety signals observed

Hb responses have been maintained

• No RBC transfusions have been needed during dosing at 400 mg or 500 mg BID BCX9930

• Improvement in biomarkers of hemolysis and PNH RBC clone size have been maintained

No discontinuations from the trial

The safety and efficacy data collected from these patients in the long-term safety trial provides the company with a high degree of confidence for the success of the pivotal trial



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