PIVOT-PO Trial Success:
-
Therapeutics' Phase III PIVOT-PO trial evaluating Tebipenem HBr in patients with cUTI met its primary endpoint, stopping early for efficacy.
- The positive outcome supports the thesis that Tebipenem HBr can deliver comparable treatment outcomes to standard of care IV carbapenem therapy, with no new safety concerns.
Financial Impact and Cash Runway:
- Spero reported a
net loss of
$1.7 million for Q2 2025, compared to
$17.9 million in Q2 2024.
- The company now anticipates its cash runway to extend into 2028, primarily due to cost savings from the early termination of the PIVOT-PO trial.
Tebipenem HBr's Market Potential:
- There are approximately
2.9 million episodes of complicated urinary tract infections annually in the U.S.
- Tebipenem HBr, if approved, could offer an oral alternative to IV therapy, addressing a major gap in care and potentially creating significant economic benefits for the healthcare system.
SPR720 Program Setback:
- The Phase IIa trial of SPR720, an oral treatment for Nontuberculous mycobacterial pulmonary disease, did not meet its primary endpoint.
- The trial showed potential dose-limiting safety signals, which will impact the next steps for the program's development.
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