AN2 Therapeutics Provides Update on EBO-301 Phase 2/3 Study Evaluating Epetraborole for Treatment-Refractory Mycobacterium avium Complex (MAC) Lung Disease
AN2 Therapeutics (Nasdaq: ANTX) announced that the EBO-301 Phase 2/3 study evaluating epetraborole for treatment-refractory Mycobacterium avium Complex (MAC) lung disease will be discontinued. The Phase 2 part met its primary objective of demonstrating a higher patient-reported outcome (PRO)-based clinical response rate (39.5% vs. placebo 25.0%; p=0.19), but sputum culture conversion at Month 6 was similar between treatment arms (13.2% vs. 10.0%; p=0.64). No significant safety concerns were noted.
The company will shift focus to its boron chemistry platform and other pipeline programs, including Chagas disease and melioidosis. Restructuring and cost savings are expected to extend the cash runway through 2027. Further evaluation of the EBO-301 study results will inform future development of epetraborole for NTM lung disease.
AN2 Therapeutics (Nasdaq: ANTX) ha annunciato che lo studio EBO-301 di Fase 2/3 che valuta epetraborole per la malattia polmonare da Mycobacterium avium complesso (MAC) resistente al trattamento sarà interrotto. La parte di Fase 2 ha raggiunto il suo obiettivo principale dimostrando un tasso di risposta clinica basato su risultati riferiti dai pazienti (PRO) più elevato (39.5% rispetto al placebo 25.0%; p=0.19), ma la conversione della coltura di espettorato al mese 6 è stata simile tra i gruppi di trattamento (13.2% rispetto al 10.0%; p=0.64). Non sono state rilevate preoccupazioni significative per la sicurezza.
L'azienda si concentrerà sulla sua piattaforma di chimica del boro e su altri programmi in pipeline, inclusi la malattia di Chagas e la melioidosi. Si prevede che il ristrutturazione e il risparmio sui costi estenderanno la liquidità fino al 2027. Ulteriori valutazioni dei risultati dello studio EBO-301 informeranno lo sviluppo futuro di epetraborole per la malattia polmonare NTM.
AN2 Therapeutics (Nasdaq: ANTX) anunció que el estudio EBO-301 Fase 2/3 que evalúa epetraborole para la enfermedad pulmonar por Mycobacterium avium complejo (MAC) refractaria al tratamiento será descontinuado. La parte de Fase 2 cumplió su objetivo principal de demostrar una tasa de respuesta clínica basada en resultados reportados por el paciente (PRO) más alta (39.5% frente al placebo 25.0%; p=0.19), pero la conversión del cultivo de esputo en el mes 6 fue similar entre los brazos de tratamiento (13.2% frente a 10.0%; p=0.64). No se observaron preocupaciones significativas de seguridad.
La empresa trasladará su enfoque a su plataforma de química del boro y otros programas en desarrollo, incluyendo la enfermedad de Chagas y la melioidosis. Se espera que la reestructuración y el ahorro de costos extiendan la liquidez hasta 2027. Una evaluación adicional de los resultados del estudio EBO-301 informará sobre el desarrollo futuro de epetraborole para la enfermedad pulmonar NTM.
AN2 Therapeutics (Nasdaq: ANTX)는 치료 저항성 Mycobacterium avium 복합체(MAC) 폐 질환에 대한 epetraborole를 평가하는 EBO-301 2/3상 연구가 중단될 것이라고 발표했습니다. 2상 부분은 환자가 보고한 결과(PRO) 기반의 임상 반응률이 더 높음을 입증하는 주요 목표를 달성했습니다(39.5% 대 위약 25.0%; p=0.19), 그러나 6개월째 가래 배양 전환율은 치료군 간에 비슷했습니다(13.2% 대 10.0%; p=0.64). 안전성에 대한 우려는 발견되지 않았습니다.
회사는 붕소 화학 플랫폼과 샤가스병, 멜리오이드증을 포함한 기타 파이프라인 프로그램으로 초점을 전환할 것입니다. 재구성 및 비용 절감으로 인해 2027년까지 자금이 지속될 것으로 예상됩니다. EBO-301 연구 결과에 대한 추가 평가는 NTM 폐 질환을 위한 epetraborole의 향후 개발을 안내할 것입니다.
AN2 Therapeutics (Nasdaq: ANTX) a annoncé que l'
La société se concentrera sur sa plateforme de chimie du bore et d'autres programmes en pipeline, y compris la maladie de Chagas et la melioïdose. La restructuration et les économies de coûts devraient prolonger la trésorerie jusqu'en 2027. Une évaluation ultérieure des résultats de l'étude EBO-301 éclairera le développement futur de l'epetraborole pour la maladie pulmonaire NTM.
AN2 Therapeutics (Nasdaq: ANTX) hat angekündigt, dass die EBO-301 Phase 2/3 Studie, die epetraborole zur Behandlung der behandlungsresistenten Mycobacterium avium Komplex (MAC) Lungenerkrankung bewertet, eingestellt wird. Der Teil der Phase 2 hat sein Hauptziel erreicht, eine höhere klinische Antwortquote, die auf Patientenergebnissen (PRO) beruht, zu demonstrieren (39,5 % gegenüber Placebo 25,0 %; p=0,19), jedoch war die Umstellung der Sputumkultur im Monat 6 zwischen den Behandlungsgruppen ähnlich (13,2 % gegenüber 10,0 %; p=0,64). Es wurden keine signifikanten Sicherheitsbedenken festgestellt.
Das Unternehmen wird seinen Fokus auf seine Borchemie-Plattform und andere Pipeline-Programme, einschließlich der Chagas-Krankheit und Melioidose, verlagern. Durch Umstrukturierungen und Kosteneinsparungen wird eine Liquidität bis 2027 erwartet. Eine weitere Bewertung der Ergebnisse der EBO-301 Studie wird die zukünftige Entwicklung von epetraborole für NTM Lungenerkrankungen beeinflussen.
- Phase 2 met primary objective with higher PRO-based clinical response rate.
- Epetraborole was generally well-tolerated with no significant safety concerns.
- Restructuring expected to extend cash runway through 2027.
- Focus on promising boron chemistry platform and pipeline programs in infectious diseases and oncology.
- EBO-301 study discontinued due to similar sputum culture conversion rates between treatment arms.
- Potentially lower-than-expected efficacy observed in Phase 3 led to pause in new patient enrollment.
Insights
The discontinuation of the EBO-301 Phase 2/3 study for epetraborole in treatment-refractory MAC lung disease is a significant setback for AN2 Therapeutics. While the study met its primary objective of demonstrating a higher PRO-based clinical response rate (
The company's pivot to focus on its boron chemistry platform and other pipeline programs is a strategic move to salvage value from this setback. The planned initiation of clinical trials for Chagas disease and melioidosis represents potential new avenues for growth, albeit in different therapeutic areas. This diversification strategy could help mitigate risks associated with single-product dependency.
The discontinuation of the EBO-301 study is likely to have a negative impact on AN2 Therapeutics' short-term prospects. However, the company's proactive approach to restructuring and cost-saving measures is a positive sign. By extending their cash runway through 2027, AN2 is buying time to develop its pipeline and potentially reach multiple milestones.
Investors should note the shift in focus to the company's boron chemistry platform and other programs. This diversification could reduce risk but also introduces uncertainty about future revenue streams. The company's ability to advance its pipeline, particularly in Chagas disease and melioidosis, will be crucial for its long-term value proposition. The continuation of non-dilutive funding for global health initiatives is a positive factor, potentially offsetting some R&D costs.
The failure of epetraborole in treatment-refractory MAC lung disease highlights the challenges in developing therapies for complex respiratory infections. However, AN2 Therapeutics' focus on boron chemistry remains intriguing. Boron's unique binding properties offer potential advantages in drug development, particularly for targets that have been difficult to address with traditional carbon-based molecules.
The company's pivot to Chagas disease and melioidosis represents a strategic shift towards neglected tropical diseases and biodefense. These areas often have less competition and potential for government support. The planned Phase 2 study in melioidosis, aiming to reduce the high mortality rate, could be particularly impactful if successful. Investors should watch for progress in these new indications and any emerging data from the company's early-stage oncology programs, which could provide new growth opportunities.
EBO-301 study to be discontinued following topline results from Phase 2 part of the study in treatment-refractory patients with MAC lung disease
AN2 plans to shift focus to internal boron chemistry platform and ongoing pipeline programs
Company restructuring and cost savings associated with discontinuation of the EBO-301 study expected to extend cash runway through 2027
The Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (
In February, the Company voluntarily paused new patient enrollment in the Phase 3 part of the study due to potentially lower-than-expected efficacy observed in blinded aggregate data. Based on the topline data announced today, the Company will terminate the Phase 2 (80 patients) and Phase 3 parts of the EBO-301 trial (97 patients enrolled prior to pause). Oral epetraborole 500 mg daily was generally well-tolerated and the study was not terminated due to safety concerns.
“These results are deeply disappointing as there is a high unmet need for new therapies in treatment-refractory MAC lung disease,” said Eric Easom, Co-founder, Chairman, President and CEO. “We sincerely thank the patients, investigators, study site staff and AN2 employees who were part of the journey to investigate the prospects of epetraborole in this very difficult-to-treat patient population.”
“In the coming months, we will further evaluate the results from the EBO-301 study and make informed decisions regarding potential future development of epetraborole for NTM lung disease in other patient populations. In the near-term, we plan to accelerate our R&D efforts on our boron chemistry platform where we believe we have several promising programs in infectious diseases and oncology. We plan to embark on a strategic restructuring and expect to extend our cash runway through 2027, focusing our cash resources on advancing our pipeline through multiple milestones,” said Easom.
AN2’s core technology approach is based on the use of boron chemistry for its research and development initiatives. Boron has a distinctive ability to bind with biological targets through a reversible covalent bond and the potential to address biological targets that have been difficult to inhibit using traditional carbon-based molecules.
Pipeline Programs/ Milestones
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Chagas Disease: The Company plans to initiate Phase 1 clinical development of its product candidate aimed to cure chronic Chagas disease, a disease that affects an estimated 6-7 million people worldwide including approximately 300,000 in the
U.S. and causes severe cardiac disease and death. -
Melioidosis: The Company plans to initiate a Phase 2 study with epetraborole in melioidosis, a deadly bacterial infection and global bioterrorism threat, with a goal of significantly reducing the 3-month mortality rate of ~
50% . - Early-Stage Pipeline: Additional research programs are underway and focused on targets in infectious diseases and oncology with high unmet needs. The Company anticipates multiple development compounds within its cash runway.
- Global Health: The Company will continue its efforts to tackle global health disease areas through non-dilutive funding, including tuberculosis and malaria, funded by the Gates Foundation.
About AN2 Therapeutics, Inc.
AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, NTM, and melioidosis, along with early-stage programs focused on targets in infectious diseases and oncology. For more information, please visit our website at www.an2therapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the Company’s plans to shift its focus to its internal boron chemistry platform and ongoing pipeline programs; strategic restructuring; cash runway; further evaluation of the results from the EBO-301 study and any future development of epetraborole for NTM lung disease; acceleration of R&D efforts on the Company’s boron chemistry platform; potential for the identification of development compounds in infectious disease or oncology; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: potential disruptions related to AN2’s restructuring plans and its ability to implement its plans for its internal boron chemistry platform and ongoing pipeline programs; timely enrollment of patients in AN2’s existing and future clinical trials; AN2’s ability to procure sufficient supply of its product candidates for its existing and future clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; continued funding by the National Institute of Allergy and Infectious Disease (NIAID) of the Company’s development program for melioidosis; AN2’s ability to obtain, maintain, or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts; and other risks, including those described under the heading “Risk Factors” in AN2’s reports filed with the
View source version on businesswire.com: https://www.businesswire.com/news/home/20240808125351/en/
Lucy O. Day
Chief Financial Officer
l.day@an2therapeutics.com
Anne Bowdidge
Investor Relations
abowdidge@an2therapeutics.com
Source: AN2 Therapeutics, Inc.
FAQ
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