Spero Therapeutics Announces SPR720 Phase 2a Interim Results and Provides a Business Update
Spero Therapeutics announced that its Phase 2a study of SPR720 for Nontuberculous Mycobacterial Pulmonary Disease failed to meet its primary endpoint. The interim analysis showed antimicrobial activity but insufficient separation from placebo, with safety concerns including three cases of reversible grade 3 hepatotoxicity. The company is suspending the SPR720 program and implementing a 39% workforce reduction.
The company reported an unaudited Q3 2024 cash balance of $76.3 million, with runway extended into mid-2026. The Phase 3 PIVOT-PO trial of tebipenem HBr remains on track for completion in 2H 2025.
Spero Therapeutics ha annunciato che il suo studio di fase 2a di SPR720 per la Malattia Polmonare da Micobatteri Non Tubercolari non ha raggiunto il suo obiettivo primario. L'analisi intermedia ha mostrato un'attività antimicrobica, ma una separazione insufficiente dal placebo, con preoccupazioni per la sicurezza, tra cui tre casi di epatotossicità di grado 3 reversibile. L'azienda sta sospendendo il programma SPR720 e attuando una riduzione del personale del 39%.
L'azienda ha riportato un saldo di cassa non verificato per il terzo trimestre del 2024 di 76,3 milioni di dollari, con una disponibilità estesa fino a metà 2026. Il trial di fase 3 PIVOT-PO di tebipenem HBr rimane in linea per il completamento nel secondo semestre del 2025.
Spero Therapeutics anunció que su estudio de fase 2a de SPR720 para la Enfermedad Pulmonar por Micobacterias No Tuberculosas no logró cumplir su objetivo primario. El análisis interino mostró actividad antimicrobiana, pero una separación insuficiente respecto al placebo, con preocupaciones de seguridad que incluyen tres casos de hepatotoxicidad reversible de grado 3. La compañía suspenderá el programa SPR720 y llevará a cabo una reducción del 39% en la fuerza laboral.
La compañía reportó un saldo de efectivo no auditado para el tercer trimestre de 2024 de 76,3 millones de dólares, con un margen de tiempo extendido hasta mediados de 2026. El ensayo de fase 3 PIVOT-PO de tebipenem HBr sigue en camino para completarse en el segundo semestre de 2025.
Spero Therapeutics는 SPR720의 비결핵성 마이코박테리아 폐 질환에 대한 2a 단계 연구가 주요 목표를 달성하지 못했다고 발표했습니다. 중간 분석 결과 항균 활동이 나타났으나 위약과의 충분한 차별성이 없었고, 안전성 문제로는 가역적인 3등급 간독성 사례가 세 건 있었습니다. 회사는 SPR720 프로그램을 중단하고 39%의 인원 감축을 시행할 예정입니다.
회사는 2024년 3분기 비 감사 현금 잔고가 7630만 달러이며, 자금이 2026년 중반까지 연장되었다고 보고했습니다. tebipenem HBr의 3상 PIVOT-PO 시험은 2025년 하반기 완료를 목표로 진행되고 있습니다.
Spero Therapeutics a annoncé que son étude de phase 2a sur SPR720 pour la Maladie Pulmonaire à Mycobactéries Non Tuberculeuses n'a pas atteint son objectif principal. L'analyse intermédiaire a montré une activité antimicrobienne mais une séparation insuffisante par rapport au placebo, avec des inquiétudes sécuritaires comprenant trois cas d'hépatotoxicité réversible de grade 3. L'entreprise suspend le programme SPR720 et met en œuvre une réduction de 39 % de la main-d'œuvre.
L'entreprise a rapporté un solde de trésorerie non vérifié pour le troisième trimestre 2024 de 76,3 millions de dollars, avec une marge de manœuvre prolongée jusqu'à mi-2026. L'essai de phase 3 PIVOT-PO de tebipenem HBr est toujours sur la bonne voie pour être achevé au second semestre 2025.
Spero Therapeutics gab bekannt, dass die Phase-2a-Studie zu SPR720 für die Nichttuberkulöse Mykobakterielle Lungenerkrankung ihr Hauptziel nicht erreicht hat. Die Zwischenanalyse zeigte eine antimikrobielle Aktivität, jedoch eine unzureichende Trennung vom Placebo, mit Sicherheitsbedenken, die drei Fälle von reversibler Hepatotoxizität der Grad 3 umfassten. Das Unternehmen setzt das SPR720-Programm aus und führt eine Reduzierung der Belegschaft um 39 % durch.
Das Unternehmen berichtete von einem nicht testierten Kassenstand für das 3. Quartal 2024 von 76,3 Millionen US-Dollar, mit einer Laufzeit bis Mitte 2026. Die Phase-3-Studie PIVOT-PO zu tebipenem HBr bleibt auf Kurs zur Vollendung in der zweiten Jahreshälfte 2025.
- Cash position remains strong with $76.3M in Q3 2024
- Cost-cutting measures extend cash runway into mid-2026
- Tebipenem HBr Phase 3 trial remains on track
- Received $47.5M milestone payment from GSK partnership
- SPR720 Phase 2a trial failed to meet primary endpoint
- Three cases of grade 3 hepatotoxicity reported in SPR720 trial
- 39% workforce reduction announced
- Suspension of SPR720 development program
Insights
The interim analysis of SPR720's Phase 2a trial reveals significant setbacks for Spero Therapeutics. The trial's failure to meet its primary endpoint, coupled with three cases of grade 3 hepatotoxicity, raises serious safety concerns. The company's decision to suspend the SPR720 program and implement a
However, the company's financial position remains relatively stable with
The market implications of this development are significant. The suspension of SPR720 eliminates one potential revenue stream but the strategic restructuring demonstrates prudent financial management. The workforce reduction will substantially decrease operational costs, while the extended cash runway provides adequate support for advancing remaining pipeline assets.
The GSK partnership for tebipenem HBr remains a key value driver, with
Phase 2a proof-of-concept study of SPR720 for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) did not meet its primary endpoint, based on planned interim analysis of 16 patients
Phase 3 PIVOT-PO trial of tebipenem HBr remains on track for enrollment completion in 2H 2025
Cash runway extended into mid-2026 following a reduction in workforce and restructuring of operations; Unaudited Q3 2024 ending cash balance of
CAMBRIDGE, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that a planned interim analysis of the Phase 2a proof-of-concept study of SPR720 for the treatment of NTM-PD demonstrated that the program did not meet its primary endpoint. While the data showed antimicrobial activity associated with SPR720, the interim analysis did not show sufficient separation from placebo and highlighted potential dose limiting safety issues in subjects dosed at 1,000 mg orally once daily, including three cases of reversible grade 3 hepatotoxicity. In evaluating the totality of both the efficacy and safety data, the Company has elected to suspend its current development program for SPR720 and will evaluate other potential paths forward as the remaining data are collected and analyzed.
As a result of the suspension of the current SPR720 development program, Spero will undergo a restructuring and reduction in force of approximately
“Spero launched its proof-of-concept clinical study for SPR720 as a monotherapy to evaluate its potential efficacy and safety in treating NTM-PD. While a planned interim analysis provided evidence of antimicrobial activity, the trial unfortunately did not meet the primary endpoint,” said Sath Shukla, Spero’s President and Chief Executive Officer. “We are therefore suspending development of the SPR720 program and making adjustments to our organization accordingly. I want to offer my sincere thanks to all our Spero SPR720 colleagues, along with our investigators and patients, for their dedication in seeking new treatment options for this devastating disease. We remain committed to bringing forward new treatment options for patients in need, as we continue to advance our tebipenem HBr and SPR206 programs.”
Restructuring to Prioritize Programs and Capital Allocation
Spero closed the third quarter ended September 30, 2024, with an unaudited cash estimate of
SPR720
SPR720 is an oral, chemically stable phosphate ester prodrug that is converted rapidly in vivo to SPR719, the active moiety. SPR719 targets the ATPase site of DNA gyrase B in mycobacteria, a mechanism that is distinct from that of other antibiotics in use for Non Tuberculous Mycobacterial-Pulmonary Disease (NTM-PD).
Recent updates:
- Phase 2a trial – enrollment concluded in July 2024, with 25 non-refractory patients enrolled in the proof-of-concept trial evaluating SPR720 in NTM-PD. A planned interim analysis based on 16 patients indicated the trial did not meet its primary endpoint of differentiation from placebo in the rate of change in log10 colony forming units per milliliter (CFU/mL). In addition, analysis of the full 25 patient safety data highlighted potential dose limiting safety issues in patients dosed at 1,000mg orally once daily, including three cases of reversible grade 3 hepatotoxicity. The Company plans to complete data analysis of all enrolled patients (n=25) and determine the next steps for the SPR720 program over the next several months. For more information on the trial, see ClinicalTrials.gov identifier NCT05496374.
Tebipenem HBr
Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI including acute pyelonephritis (AP) to help patients avoid hospitalizations or reduce duration of in-patient therapy. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories. Spero received
- Enrollment on track in PIVOT-PO, the global Phase 3 clinical trial of tebipenem HBr in patients with cUTI. This randomized, double-blinded trial compares oral tebipenem HBr with intravenous imipenem cilastatin, in hospitalized adult patients with cUTI/AP. The primary endpoint is overall response (a combination of clinical cure and favorable microbiological response) at the Test-of-Cure (TOC) visit. Target enrollment for the trial is approximately 2,648 patients, with enrollment completion expected in the second half of 2025. For more information on PIVOT-PO, refer to ClinicalTrials.gov ID NCT06059846.
SPR206
SPR206 is an investigational, intravenously administered next-generation polymyxin that has shown antibiotic activity against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacterales, Acinetobacter baumannii and Pseudomonas aeruginosa in preclinical studies.
- The U.S. Food and Drug Administration (FDA) cleared the Company's IND for a Phase 2 trial in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). The Company maintains its guidance to initiate the trial, contingent on availability of non-dilutive funding.
About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a multi-asset clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the timing, progress and results of the Company’s preclinical studies, clinical trials and research and development programs; management’s assessment of the results of such preclinical studies and clinical trials; and the expected cost-savings from the Company’s reduction in workforce and restructuring of its operations, the Company’s anticipated expenses and its anticipated cash runway . In some cases, forward-looking statements may be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms or other similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual results to differ materially from those indicated by such forward looking statements, including whether tebipenem HBr, SPR720 and SPR206 will advance through the clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; Spero's need for additional funding; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; Spero's leadership transitions; whether Spero's cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the "Risk Factors" set forth in filings that Spero periodically makes with the SEC. The forward-looking statements included in this press release represent Spero's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Spero explicitly disclaims any obligation to update any forward-looking statements.
Investor Relations Contact:
Shai Biran, PhD
Spero Therapeutics
IR@Sperotherapeutics.com
Media Inquiries:
media@sperotherapeutics.com
FAQ
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