Spero Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2013-01-01
- Employees
- 46
- Market Cap
- $74.5M
- Introduction
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.
FDA Approves Blujepa, First New Class of Oral Antibiotic for UTIs in Nearly 30 Years
• GSK's Blujepa (gepotidacin) has received FDA approval for treating uncomplicated urinary tract infections, marking the first new class of oral antibiotics for UTIs in nearly three decades.
• The novel triazaacenaphthylene antibiotic demonstrated non-inferiority or superiority to nitrofurantoin in clinical trials, offering a new treatment option amid rising antibiotic resistance concerns.
• Blujepa works through a unique dual-enzyme inhibition mechanism that may reduce the potential for resistance development, with commercial availability expected in the second half of 2025.
Spero Therapeutics' Tebipenem HBr Phase 3 Trial Enrollment Nears Completion
• 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.
Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments
• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions.
• Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways.
• These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets.
• The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
Capricor Therapeutics Completes FDA Submission for Deramiocel in DMD Cardiomyopathy
• Capricor Therapeutics has completed its Biologics License Application (BLA) submission to the FDA for deramiocel to treat Duchenne muscular dystrophy (DMD) cardiomyopathy.
• The BLA is supported by data from Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials, showing attenuation of cardiac implications of DMD.
• The FDA has been requested to grant priority review, potentially reducing the review period to six months from the standard ten months.
• The BLA submission triggers a $10 million milestone payment to Capricor from its distribution partner, Nippon Shinyaku.
Puma Biotechnology's Stock Surges Amid Promising Nerlynx Sales and Alisertib Development
• Puma Biotechnology's stock has increased by 24% over the past three months, driven by strong sales of Nerlynx and progress in alisertib development.
• Nerlynx sales for the first nine months of 2024 reached $140.8 million, leading to an updated full-year sales guidance of $187-$190 million.
• Puma Biotechnology initiated the Phase II ALISCA-Breast1 study to evaluate alisertib in metastatic breast cancer, with potential FDA approval pathway.
• A Phase II study, ALISCA-Lung1, is also underway to assess alisertib as a monotherapy for extensive stage small cell lung cancer, with interim data expected in 2025.
Tagrisso Approved in EU for Unresectable EGFR-Mutated Non-Small Cell Lung Cancer
• AstraZeneca's Tagrisso (osimertinib) gains EU approval for treating unresectable EGFR-mutated non-small cell lung cancer (NSCLC) in adults after platinum-based chemoradiation therapy.
• The approval is based on the Phase III LAURA trial, demonstrating an 84% reduction in disease progression or death risk compared to placebo, with a median PFS of 39.1 months.
• Tagrisso is now the first and only EGFR inhibitor approved in the EU for this specific NSCLC patient population, establishing a new standard of care.
• This approval marks the fifth major authorization based on the LAURA trial, with ongoing regulatory reviews in China, Japan, and other countries.
FDA Approves Ryoncil, First Mesenchymal Stromal Cell Therapy for Pediatric Steroid-Refractory Acute Graft-versus-Host Disease
• The FDA has approved Ryoncil (remestemcel-L-rknd) as the first mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients.
• Ryoncil's approval was based on a Phase III trial demonstrating a 70% overall response rate in children with SR-aGVHD after 28 days of treatment.
• This allogeneic, bone marrow-derived MSC therapy offers a new treatment option for children with SR-aGVHD who do not respond to steroid treatment.
• Ryoncil is administered intravenously and should be monitored for infusion reactions; common side effects include infections, fever, hemorrhage, and abdominal pain.
Merck Discontinues Development of Vibostolimab and Favezelimab Following Futility Analysis
• Merck has halted the clinical development of vibostolimab, an anti-TIGIT antibody, after Phase 3 trials failed to meet overall survival futility criteria.
• The KeyVibe program, evaluating vibostolimab with pembrolizumab in NSCLC, is discontinued, impacting KeyVibe-003, KeyVibe-007, and KeyVibe-006 trials.
• Favezelimab, an anti-LAG-3 antibody, also sees its clinical program terminated, including the KEYFORM-008 trial for relapsed or refractory classical Hodgkin lymphoma.
• Merck will prioritize other oncology candidates, assuring the decisions weren't based on safety concerns, and data will be shared with the scientific community.
Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis
• The FDA has granted Breakthrough Therapy designation to tolebrutinib for adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
• The designation is based on positive results from the HERCULES phase 3 study, which demonstrated a 31% delay in disability progression compared to placebo.
• Tolebrutinib is the first brain-penetrant BTK inhibitor to receive this designation for MS, addressing a critical unmet need in delaying disability progression.
• Regulatory submissions for tolebrutinib are being finalized in the US and EU, with ongoing studies for primary progressive MS anticipated in H2 2025.
Keytruda/Lenvima Combo Shows Mixed Results in Gastroesophageal Adenocarcinoma Trial
• The Phase 3 LEAP-015 trial evaluated Keytruda plus Lenvima with chemotherapy for HER2-negative gastroesophageal adenocarcinoma.
• The combination significantly improved progression-free survival and objective response rate compared to chemotherapy alone.
• However, the trial failed to meet its other primary endpoint of overall survival in the final analysis.
• The safety profile of the Keytruda plus Lenvima regimen was consistent with prior studies.
Esperion Files for Canadian Approval of Nexletol and Nexlizet for LDL-C Reduction and Cardiovascular Risk
• Esperion has submitted New Drug Submissions (NDSs) in Canada for Nexletol and Nexlizet, seeking approval for LDL-C reduction and cardiovascular risk management.
• Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) are oral, non-statin medications already approved in the United States and Europe.
• Heart disease is a leading cause of death in Canada, affecting approximately 2.6 million adults, highlighting the need for new treatment options.
• The submissions are based on data, including the CLEAR outcomes study, supporting the drugs' efficacy in reducing cardiovascular risk and LDL-C levels.
Cytokinetics' Aficamten Advances in Regulatory Review for Obstructive Hypertrophic Cardiomyopathy
• The EMA has validated Cytokinetics' Marketing Authorization Application (MAA) for aficamten, a cardiac myosin inhibitor, for treating obstructive hypertrophic cardiomyopathy (HCM).
• The FDA has accepted the New Drug Application (NDA) for aficamten with a PDUFA target action date of September 26, 2025, and no advisory committee meeting is planned.
• Aficamten significantly improved exercise capacity and clinical outcomes in the SEQUOIA-HCM Phase 3 trial, supporting regulatory submissions in the U.S., Europe, and China.
Advancements in Complicated Urinary Tract Infection (cUTI) Therapeutics
• 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.
FDA Grants Accelerated Approval to Jazz Pharmaceuticals' Ziihera for HER2-Positive Biliary Tract Cancer
• The FDA has granted accelerated approval to Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) for previously treated HER2-positive biliary tract cancer (BTC).
• This approval marks Ziihera as the first dual HER2-targeted bispecific antibody and chemotherapy-free option for BTC treatment in the US.
• The approval was based on a Phase IIb study demonstrating a 52% objective response rate and a median duration of response of 14.9 months.
• Jazz Pharmaceuticals is also evaluating Ziihera in studies for gastroesophageal adenocarcinoma, metastatic breast cancer, and other HER2-positive solid tumors.
TenNor's Rifasutenizol Achieves High Eradication Rate in Phase III H. pylori Trial
• TenNor Therapeutics' rifasutenizol triple therapy achieved a >90% eradication rate in treating _Helicobacter pylori_ (_H. pylori_) infection, surpassing the current standard bismuth-containing quadruple therapy (BQT).
• The Phase III trial (NCT05857163) demonstrated that the rifasutenizol regimen had a better safety and tolerability profile compared to BQT.
• High resistance rates were observed in patients treated with clarithromycin, metronidazole, levofloxacin, and amoxicillin, highlighting the growing issue of antimicrobial resistance in _H. pylori_ strains.
• Rifasutenizol, targeting anaerobic and microaerophile bacteria, could potentially become the first new drug specifically developed for _H. pylori_ infection in over 30 years.
TenNor's Rifasutenizol Achieves High Eradication Rate in Phase III H. pylori Trial
• TenNor Therapeutics' rifasutenizol triple therapy achieved a >90% eradication rate in treating Helicobacter pylori (H. pylori) infection in a Phase III trial.
• The rifasutenizol regimen outperformed the current standard of care, bismuth-containing quadruple therapy (BQT), in H. pylori eradication.
• Rifasutenizol demonstrated a better safety and tolerability profile compared to BQT, with only 3% of patients dropping out of the trial.
• Rifasutenizol targets anaerobic and microaerophile bacteria and could be the first new drug specifically for H. pylori infection in over 30 years.
Spero Therapeutics' Tebipenem HBr Phase 3 Trial Enrollment on Track; SPR720 Development Suspended
• 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.
Spero Therapeutics Halts SPR720 Development After Phase II Failure, Focuses on Tebipenem HBr and SPR206
• Spero Therapeutics discontinued the development of SPR720 after it failed to meet the primary endpoint in a Phase IIa trial for non-tuberculous mycobacterial pulmonary disease (NTM-PD).
• The interim analysis of SPR720 showed no significant antimicrobial effect compared to placebo, leading to the suspension of the program and a 39% staff reduction.
• Spero will now prioritize tebipenem HBr, licensed to GSK, and SPR206, with ongoing trials and FDA clearance for Phase II contingent on funding.
• The company's stock price declined following the announcement, reflecting investor concerns about the future of its antibiotic pipeline.
Spero Therapeutics Halts SPR720 Development After Phase IIa Failure
• Spero Therapeutics discontinued the development of SPR720 after it failed to meet the primary endpoint in a Phase IIa trial for non-tuberculous mycobacterial pulmonary disease (NTM-PD).
• The interim analysis of the trial showed no significant antimicrobial effect compared to placebo, leading to the suspension of the SPR720 program.
• Spero plans to focus on its other antibiotic programs, including tebipenem HBr and SPR206, while also reducing its workforce by 39% to extend its cash runway.
• The company's stock price declined by over 17% following the announcement, reflecting investor concerns about the future of the SPR720 program.
Spero Therapeutics Halts SPR720 Development After Phase 2a Trial Fails to Meet Primary Endpoint
• Spero Therapeutics suspends SPR720 development for NTM-PD after Phase 2a trial fails to demonstrate sufficient separation from placebo in interim analysis.
• The Phase 2a trial showed antimicrobial activity but raised safety concerns, including reversible grade 3 hepatotoxicity at the 1,000mg dose.
• Spero will restructure operations, reducing workforce by 39% to extend cash runway into mid-2026 and focus on tebipenem HBr and SPR206.
• The company remains committed to advancing tebipenem HBr in its Phase 3 trial for cUTI and preparing for a Phase 2 trial for SPR206, pending funding.
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