Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on identifying, developing, and commercializing treatments involving bacterial infections, including multi-drug resistant bacterial infections, and rare diseases Its pipeline product candidates include Tebipenem HBr, SPR720, and SPR206. The company was founded by Ankit A. Mahadevia and Laurence Rahme in April 2013 and is headquartered in Cambridge, MA.
Clinical Trials
30
6 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2013
Active, not recruiting
6
20.0%
Completed
22
73.3%
Recruiting
1
3.3%
Terminated
1
3.3%
No approval data available
- Spero Therapeutics has appointed Debra Jeske Zack, M.D., Ph.D., a board-certified rheumatologist with over 25 years of experience, as chief medical officer. - Dr. Zack will lead the clinical development strategy for SP001, a Phase 2-ready third-generation anti-CD40L monoclonal antibody targeting IgG4-related disease. - SP001 is a fully humanized, Fc-silent IgG1 antibody designed to inhibit CD40L while addressing platelet activation concerns seen with earlier anti-CD40L therapies. - The antibody offers a non-B-cell-depleting approach with potential applications across multiple immune-mediated conditions beyond IgG4-RD.
- Spero Therapeutics announced a $105 million non-recourse, non-dilutive royalty financing with Healthcare Royalty (KKR) backed by future Utebzi milestone and royalty payments. - Proceeds will primarily fund Phase 2 development of SP001, a third-generation Fc-silent anti-CD40L monoclonal antibody in-licensed from Innovent Biologics for immune-mediated diseases. - The financing extends Spero's cash runway into the second half of 2029, with the company retaining 35% of GSK payments after loan repayment. - The transaction follows last month's FDA approval of Utebzi, the first oral carbapenem therapy, for complicated urinary tract infections.
- Innovent Biologics and Spero Therapeutics announced an exclusive global license agreement for IBI355 (SP001), a third-generation Fc-silent anti-CD40L monoclonal antibody, valued at approximately $1.1 billion. - Spero gains exclusive worldwide rights outside Greater China and plans to initiate a Phase 2 trial in IgG4-related disease (IgG4-RD) in Q2 2027. - Innovent retains rights in Greater China and expects to launch a Phase 2 trial for Sjögren's disease (SjD) by early 2027, building on Phase 1b data presented at EULAR 2026. - The non-B-cell-depleting antibody is designed to address platelet activation concerns of earlier anti-CD40L candidates while preserving IgG-like half-life through FcRn interaction.
- Perspective Therapeutics appointed biotech veteran Joel Sendek as Chief Financial Officer, bringing extensive experience from four previous CFO roles and over $2.5 billion in fundraising expertise. - Sendek joins as the radiopharmaceutical company advances three clinical programs using proprietary 212Pb alpha-emitting isotope technology for targeted cancer treatment. - The appointment comes during ongoing Phase 1/2a trials for neuroendocrine tumors, melanoma, and solid tumors, positioning the company to establish leadership in targeted alpha radiopharmaceutical therapy.
- GSK and Spero Therapeutics announced the pivotal Phase III PIVOT-PO trial for tebipenem HBr was stopped early for efficacy following a recommendation from an Independent Data Monitoring Committee based on data from 1,690 patients. - The trial met its primary endpoint of non-inferiority compared to intravenous imipenem-cilastatin in hospitalized adult patients with complicated urinary tract infections, including pyelonephritis. - If approved, tebipenem HBr would be the first oral carbapenem antibiotic for US patients with complicated UTIs, addressing a significant unmet medical need in a market with 2.9 million annual cases. - GSK plans to include the data in a US FDA filing in the second half of 2025, marking the company's second anti-infective program stopped early for efficacy in Phase III.
- DelveInsight's 2025 pipeline analysis reveals 12+ pharmaceutical companies actively developing therapies for complicated urinary tract infections, with several candidates in advanced clinical stages. - Spero Therapeutics' tebipenem pivoxil hydrobromide completed a landmark Phase III trial (ADAPT-PO) demonstrating non-inferiority to IV ertapenem, potentially becoming the first oral carbapenem approved in the United States. - Recent regulatory approvals include GSK's Blujepa (gepotidacin) for uncomplicated UTIs and AbbVie's EMBLAVEO for complicated intra-abdominal infections, highlighting growing treatment options. - Multiple Phase III studies are underway in 2025, including pediatric trials by Menarini Group and Rempex evaluating meropenem-vaborbactam combinations for hospitalized patients.
- GSK's phase 3 PIVOT-PO trial for tebipenem HBr was stopped early after an independent monitoring committee determined the oral carbapenem antibiotic was at least as effective as intravenous treatment for complicated urinary tract infections. - The drug could become the first oral carbapenem antibiotic approved for complicated UTIs in the US, offering patients home-based treatment instead of hospital-based IV therapy. - GSK plans to file for FDA approval in the second half of 2024, following a $66 million licensing deal with Spero Therapeutics after the FDA initially rejected the drug in 2022. - The success represents a significant advance in combating antimicrobial resistance, with an estimated 2.9 million complicated UTI cases treated annually in the US at a cost of approximately $6 billion per year.
- Spero Therapeutics' Phase 3 PIVOT-PO trial for Tebipenem HBr has surpassed 60% enrollment as of December 31, 2024, and is on track for completion in the second half of 2025. - The PIVOT-PO trial evaluates Tebipenem HBr's efficacy in treating complicated urinary tract infections (cUTI) and acute pyelonephritis (AP) in hospitalized adult patients. - Spero Therapeutics reported cash and cash equivalents of $52.9 million as of December 31, 2024, expected to fund operations into mid-2026. - Interim leadership changes were announced, with Esther Rajavelu appointed Interim President and CEO, and Frank Thomas as Chairman of the Board.
• Several pharmaceutical and biotech companies are actively developing novel therapies for complicated urinary tract infections (cUTIs). • Spero Therapeutics' Tebipenem Pivoxil Hydrobromide is in Phase III clinical trials, representing a late-stage advancement in cUTI treatment. • Other companies like Iterum Therapeutics and Venatorx are also contributing to the cUTI therapeutics market with drugs like Sulopenem. • Emerging therapies cover various routes of administration, molecule types, and mechanisms of action, offering diverse treatment options.
• Spero Therapeutics' Phase 3 PIVOT-PO trial of tebipenem HBr for complicated urinary tract infections remains on track, with enrollment expected to complete in the second half of 2025. • The company has suspended development of SPR720 for nontuberculous mycobacterial pulmonary disease after interim analysis showed insufficient separation from placebo. • Spero's SPR206 program, targeting multi-drug resistant Gram-negative pathogens, is ready for Phase 2 trials, contingent on securing non-dilutive funding. • With a restructuring and reduction in force, Spero Therapeutics extends its cash runway into mid-2026, supported by a Q3 2024 cash balance of $76.3M.
