- Baudax Bio Inc BXRX announced top-line results from its Phase 2 clinical trial of BX1000 for neuromuscular blockade (NMB) in elective surgery patients.
- In March, Baudax Bio announced results from the second preplanned interim analysis of its Phase 2 trial of BX1000.
- Results of the study showed that BX1000 met the primary endpoint of readiness for intubation (evaluated as "Good" or "Excellent") at all dose levels assessed.
- No severe adverse events were observed in any dose regimen.
- Results showed that all patients in three BX1000 study cohorts were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds.
- There was evidence of a dose response across the three doses of BX1000, and the degree of blockade for the highest dose group appears comparable to that of the "standard" dose of rocuronium (0.6 mg/kg) employed in the study.
- There will be further patient safety follow-up at 28 days after surgery and additional analyses of neuromuscular blockade data in the coming weeks.
- The company will continue the development program for BX 1000 with a target of submitting a New Drug Application by approximately year-end 2025.
- "We believe these results demonstrate that BX1000 at the highest dose compares favorably to rocuronium, and when combined with our reversal agent BX3000, may provide improved control of neuromuscular paralysis for surgical patients," said Gerri Henwood, President & CEO of Baudax Bio.
- Price Action: BXRX shares are 31.90% at $2.48 on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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