Spero Therapeutics Appoints New Interim Leadership and Update on Trials

Spero Therapeutics Announces Leadership Changes and Pipeline Updates

Esther Rajavelu Takes the Helm as Interim CEO, Frank Thomas Appointed Chairman

Company's Response to SEC Inquiry Leads to Interim Leadership Restructuring

Phase 3 PIVOT-PO Trial Achieves Milestone with Over 60% Enrollment

CAMBRIDGE, Mass. -- Spero Therapeutics, Inc. (NASDAQ: SPRO), a biopharmaceutical company dedicated to developing treatments for rare diseases and serious bacterial infections, has provided an important update concerning its leadership and ongoing clinical trials.

Interim Leadership Restructuring

Effective today, Spero Therapeutics has appointed Esther Rajavelu as its Interim President and Chief Executive Officer, succeeding Sath Shukla, who is on a voluntarily paid administrative leave. Sath will continue as a Board member during this period. Additionally, Frank Thomas has been appointed as Chairman of the Board, succeeding Dr. Ankit Mahadevia, who will also remain as a board member. These changes align with the board's commitment to exemplary governance practices in response to a Wells Notice from the Securities and Exchange Commission (SEC) regarding certain disclosures made in 2022.

“The Board’s decision reflects our confidence in Esther’s leadership capabilities,” expressed Frank Thomas. “This restructuring will allow Spero to maintain its focus on advancing key programs. We appreciate our outgoing leaders for their ongoing dedication to Spero.”

Progress on PIVOT-PO Clinical Trial

Looking ahead, Spero Therapeutics is excited about the progress in its Phase 3 clinical trial known as PIVOT-PO for Tebipenem HBr. As of now, enrollment has surpassed 60%, with the full participant goal anticipated to be met in the second half of 2025. This trial aims to evaluate tebipenem HBr, an innovative oral carbapenem antibiotic, which seeks to improve treatment options for complicated urinary tract infections (cUTI) and avoid unnecessary hospital admissions.

Details of the PIVOT-PO Trial

The PIVOT-PO trial is a global, randomized, double-blind study comparing the efficacy of oral tebipenem HBr against intravenous imipenem cilastatin in hospitalized adults suffering from cUTI and related complications. This initiative is a significant component of the company's pipeline aimed at addressing critical medical needs.

Financial Insights and Runway

Spero Therapeutics reports a solid financial position, with cash and equivalents amounting to $52.9 million as of the end of the last year. The company has laid out a financial strategy that ensures its operations and development initiatives are funded through mid-2026, bolstering confidence in the advancement of its clinical programs.

Pipeline Overview

Spero's pipeline includes other promising candidates such as SPR720, which is designed for non-tuberculous mycobacterial infections, and SPR206, a next-generation antibiotic targeting resistant pathogens, with the latter having recently received FDA clearance for its Phase 2 trial.

Looking Forward

With these leadership changes and continued progress in its clinical trials, Spero is well-positioned for future advancements. The initiatives aimed at tackling drug-resistant infections are critical, and the company's commitment to innovation is clear.

Frequently Asked Questions

What leadership changes were made at Spero Therapeutics?

Esther Rajavelu has been appointed as Interim President and CEO, while Frank Thomas takes on the role of Chairman of the Board.

How is Spero Therapeutics progressing in clinical trials?

The PIVOT-PO trial for tebipenem HBr has reached over 60% enrollment, with full enrollment expected by mid-2025.

What is tebipenem HBr developed for?

Tebipenem HBr is an investigational oral antibiotic aimed at treating complicated urinary tract infections and reducing hospitalization rates.

How is Spero's financial outlook?

Spero Therapeutics has a cash balance of $52.9 million, expected to support operations through mid-2026.

What other products are in Spero’s pipeline?

Alongside tebipenem HBr, Spero is developing SPR720 for mycobacterial diseases and SPR206 for bacterial pneumonia targeting drug-resistant pathogens.

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