Bionomics Announces Successful End-of-Phase 2 Meeting with the FDA on the Development of BNC210 in Post-Traumatic Stress Disorder
Bionomics (BNOX) announced successful outcomes from an End-of-Phase 2 meeting with the FDA for its lead asset BNC210 in treating post-traumatic stress disorder (PTSD). The FDA provided favorable feedback on the Phase 3 study design and safety monitoring plans, potentially paving the way for a New Drug Application (NDA) submission with a single Phase 3 trial. Key agreements include:
1. Using CAPS-5 as the primary endpoint and CGI-S as a key secondary endpoint
2. Testing two doses: 900 mg BID (efficacious dose) and 600 mg BID (lower dose)
3. Implementing a hepatic safety monitoring plan
Bionomics plans to initiate the Phase 3 program in Q4 2024, marking its transformation into a pre-commercial organization. The company believes BNC210 could potentially transform PTSD treatment, a disorder affecting about 7% of Americans in their lifetime.
Bionomics (BNOX) ha annunciato risultati positivi da un incontro di fine Fase 2 con la FDA per il suo principale asset BNC210 nel trattamento del disturbo da stress post-traumatico (PTSD). La FDA ha fornito feedback favorevoli sul design dello studio di Fase 3 e sui piani di monitoraggio della sicurezza, aprendo potenzialmente la strada per una presentazione di domanda di Nuovo Farmaco (NDA) con un singolo studio di Fase 3. Gli accordi chiave includono:
1. Utilizzo di CAPS-5 come endpoint primario e CGI-S come endpoint secondario chiave
2. Test di due dosi: 900 mg BID (dose efficace) e 600 mg BID (dose inferiore)
3. Implementazione di un piano di monitoraggio della sicurezza epatica
Bionomics prevede di avviare il programma di Fase 3 nel Q4 2024, segnando la sua trasformazione in un'organizzazione pre-commerciale. L'azienda crede che BNC210 potrebbe trasformare il trattamento del PTSD, un disturbo che colpisce circa il 7% degli americani nella loro vita.
Bionomics (BNOX) anunció resultados exitosos de una reunión de fin de Fase 2 con la FDA para su activo principal BNC210 en el tratamiento del trastorno de estrés postraumático (TEPT). La FDA proporcionó comentarios favorables sobre el diseño del estudio de Fase 3 y los planes de monitoreo de seguridad, lo que podría allanar el camino para una presentación de Solicitud de Nuevo Medicamento (NDA) con un solo ensayo de Fase 3. Los acuerdos clave incluyen:
1. Uso de CAPS-5 como el objetivo primario y CGI-S como un objetivo secundario clave
2. Prueba de dos dosis: 900 mg BID (dosis eficaz) y 600 mg BID (dosis más baja)
3. Implementación de un plan de monitoreo de seguridad hepática
Bionomics planea iniciar el programa de Fase 3 en el Q4 de 2024, marcando su transformación en una organización precomercial. La empresa cree que BNC210 podría transformar el tratamiento del TEPT, un trastorno que afecta aproximadamente al 7% de los estadounidenses en su vida.
바이오노믹스 (BNOX)는 외상 후 스트레스 장애 (PTSD) 치료를 위한 주요 자산인 BNC210에 대해 FDA와의 2상 종료 회의에서 성공적인 결과를 발표했습니다. FDA는 3상 연구 설계 및 안전 모니터링 계획에 대해 긍정적인 피드백을 제공해, 단일 3상 시험으로 신약신청(NDA)을 제출할 가능성을 열어주었습니다. 주요 합의 사항은 다음과 같습니다:
1. CAPS-5를 주요 평가변수로 사용하고 CGI-S를 주요 보조 평가변수로 설정
2. 두 가지 용량 테스트: 900 mg BID (효능 용량) 및 600 mg BID (하한 용량)
3. 간 안전성 모니터링 계획의 구현
바이오노믹스는 2024년 4분기에 3상 프로그램을 시작할 계획이며, 이는 사전 상업화 조직으로의 변화를 의미합니다. 이 회사는 BNC210이 PTSD 치료를 변혁할 수 있다고 믿고 있으며, 이 장애는 미국인의 약 7%가 일생 동안 경험합니다.
Bionomics (BNOX) a annoncé des résultats positifs lors d'une réunion de fin de Phase 2 avec la FDA pour son actif principal BNC210 dans le traitement du trouble de stress post-traumatique (PTSD). La FDA a fourni des commentaires favorables concernant le plan d'étude de Phase 3 et les plans de surveillance de la sécurité, ouvrant potentiellement la voie à une demande de nouveau médicament (NDA) avec un seul essai de Phase 3. Les accords clés comprennent :
1. Utilisation de CAPS-5 comme critère principal et CGI-S comme critère secondaire clé
2. Test de deux doses : 900 mg BID (dose efficace) et 600 mg BID (dose inférieure)
3. Mise en œuvre d'un plan de surveillance de la sécurité hépatique
Bionomics prévoit de lancer le programme de Phase 3 au T4 2024, marquant sa transformation en une organisation pré-commerciale. L'entreprise est convaincue que BNC210 pourrait transformer le traitement du PTSD, un trouble qui affecte environ 7 % des Américains au cours de leur vie.
Bionomics (BNOX) gab Erfolge aus einem Abschlussmeeting der Phase 2 mit der FDA für sein Hauptprodukt BNC210 zur Behandlung von posttraumatischer Belastungsstörung (PTBS) bekannt. Die FDA lieferte positive Rückmeldungen zum Studienentwurf der Phase 3 und zu den Sicherheitsüberwachungsplänen, was möglicherweise den Weg für eine Einreichung eines Neuantrag auf ein Medikament (NDA) mit einer einzigen Phase-3-Studie ebnet. Wichtige Vereinbarungen beinhalten:
1. Verwendung von CAPS-5 als primäres Endziel und CGI-S als wichtiges sekundäres Endziel
2. Testen zweier Dosen: 900 mg BID (wirksame Dosis) und 600 mg BID (niedrigere Dosis)
3. Implementierung eines Überwachungsplans für die Leber-Sicherheit
Bionomics plant, das Phase-3-Programm im Q4 2024 zu starten, was den Wandel in eine vor-kommerzielle Organisation markiert. Das Unternehmen glaubt, dass BNC210 die Behandlung von PTBS transformieren könnte, einer Störung, die etwa 7 % der Amerikaner im Laufe ihres Lebens betrifft.
- FDA provided favorable feedback on Phase 3 study design and safety monitoring plans
- Potential path to NDA submission with a single Phase 3 trial
- Agreement reached on primary and secondary endpoint measures
- Plans to initiate Phase 3 program in Q4 2024
- BNC210 demonstrated efficacy across multiple stress and anxiety disorders
- Need for hepatic safety monitoring plan due to liver function test findings
- Requirement to test a lower dose (600 mg BID) in addition to the efficacious dose (900 mg BID)
Insights
The FDA's favorable feedback on Bionomics' End-of-Phase 2 meeting for BNC210 in PTSD treatment is a significant milestone. Here are the key takeaways:
- The FDA agreed to a single Phase 3 trial design, potentially expediting the path to NDA submission. This is uncommon and highly positive, as typically two Phase 3 trials are required.
- The use of CAPS-5 as the primary endpoint and CGI-S as a key secondary endpoint aligns with industry standards for PTSD trials, increasing the likelihood of success.
- Testing two doses (900 mg BID and 600 mg BID) demonstrates a balanced approach to efficacy and safety, particularly regarding liver function tests.
- The company's proactive approach to hepatic safety monitoring, including monitoring for excessive alcohol use, shows diligence in addressing potential safety concerns.
While the news is promising, investors should note that Phase 3 trials still carry significant risks. The Q4 2024 start date for the PTSD trial suggests a lengthy timeline before potential commercialization. The company's financial position and burn rate will be important factors to monitor during this extended development period.
From a financial perspective, this development presents a mixed bag for Bionomics:
- The potential for a single Phase 3 trial could significantly reduce development costs and time to market, improving the company's financial outlook.
- However, the Q4 2024 start date for the PTSD trial indicates a substantial period before potential revenue generation, which may necessitate additional financing.
- The company's dual focus on PTSD and social anxiety disorder (SAD) with the AFFIRM-1 trial demonstrates a diversified pipeline strategy, potentially mitigating risk.
- Investors should closely monitor Bionomics' cash runway and burn rate as it transitions into a pre-commercial organization, which typically involves increased expenses.
While the news is positive for Bionomics' long-term prospects, the near-term financial implications are less clear. The company's ability to secure partnerships or additional funding to support its clinical programs will be crucial. The stock may see increased volatility as the market reassesses the company's valuation based on this accelerated development pathway.
From a market perspective, Bionomics' progress with BNC210 for PTSD treatment is noteworthy:
- The PTSD market is substantial, affecting
7% of Americans in their lifetime, indicating a large potential patient population. - Current PTSD treatments often have efficacy and significant side effects, creating a clear unmet medical need that BNC210 could potentially address.
- The novel mechanism of action of BNC210 as an allosteric ion channel modulator could provide a competitive advantage in the CNS disorder treatment landscape.
- The company's dual focus on PTSD and social anxiety disorder expands its potential market reach, potentially diversifying revenue streams in the future.
However, it's important to note that the CNS drug market is highly competitive and fraught with clinical failures. The success of BNC210 will depend not only on its efficacy and safety profile but also on Bionomics' ability to effectively commercialize the drug if approved. The company's transformation into a pre-commercial organization will be a critical phase to watch, as it will need to build out its marketing and sales capabilities or secure strong partnerships to maximize the potential of BNC210.
- Successful End-of-Phase 2 (EoP2) meeting with U.S. Food and Drug Administration (FDA) provides a potential path to New Drug Application (NDA) submission for BNC210 for post-traumatic stress disorder (PTSD) with a single Phase 3 trial
- Company received favorable FDA feedback on the Phase 3 study design and safety monitoring plans required for registration
- Company plans to initiate the Phase 3 program in Q4 2024
- A conference call and webcast presentation to discuss the outcomes will be held today at 8:00 a.m. ET, details below
ADELAIDE, Australia and CAMBRIDGE, Mass., July 31, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced the favorable outcomes of an EoP2 meeting with the FDA, supporting the advancement of its lead asset BNC210 for the treatment of PTSD into Phase 3 based on the positive results of the recently completed Phase 2b ATTUNE study.
“We are very pleased with the outcomes of our EoP2 meeting with the FDA and look forward to initiating our transformation into a pre-commercial organization,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “This milestone is another testament to the strong clinical profile of BNC210, which has demonstrated efficacy across multiple stress and anxiety disorders. We believe BNC210 can potentially transform the standard-of-care in PTSD, a serious disorder impacting about
The company presented the clinical plans to registration, that alongside the positive Phase 2b ATTUNE trial include a single additional Phase 3 trial to evaluate two dose levels of BNC210 in a 12-week randomized, double-blind, placebo-controlled trial with a 52-week open-label extension. The meeting, held on June 26, 2024, was centered around the design of the Phase 3 trial that if successful may enable review of the NDA submission. Key outcomes from the discussion on the trial design included:
- Agreement was reached on the use of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as the primary endpoint measure and the Clinical Global Impressions Severity scale (CGI-S) as a key secondary endpoint measure in the placebo-controlled part of the study.
- Agreement was reached that in addition to the efficacious dose of 900 mg twice daily (BID) a lower dose of BNC210 that strikes the right balance between maintenance of efficacy and safety related to liver function tests (LFT) findings will be tested. Full justification for the proposed lower dose of 600 mg twice daily (BID) will be included in the final Ph3 PTSD trial protocol.
- High-level agreement was reached on study participant characteristics and sample size assumption methodology.
- The company received guidance related to the proposed hepatic safety monitoring plan, including monitoring for excessive alcohol use that will be implemented in the planned Phase 3 trial.
The Company plans to submit the full Phase 3 protocol for FDA review prior to trial initiation.
The company is finalizing the full study protocol and anticipates beginning the Phase 3 program in PTSD in Q4 2024.
Conference Call and Webcast Presentation
Bionomics management team will host a conference call and webcast presentation today at 8:00 a.m. ET provide a corporate update and discuss the registrational path forward for BNC210. A live Q&A session will follow the brief presentation. To participate in the conference call, please dial 1-877-407-0792 (U.S.) or 1-201-689-8263 (international) and use conference ID 13748183. To access the webcast presentation, please click here.
FOR FURTHER INFORMATION PLEASE CONTACT:
| General Rajeev Chandra Company Secretary CoSec@bionomics.com.au | Investor Relations Kevin Gardner kgardner@lifesciadvisors.com | Investor Relations Chris Calabrese ccalabrese@lifesciadvisors.com |
About Post Traumatic Stress Disorder
Post-Traumatic Stress Disorder (PTSD) is a psychiatric condition that may occur in people who have experienced or witnessed a traumatic event, series of events, or set of circumstances. People with PTSD have intense, disturbing thoughts and feelings related to their experience that persist long after the traumatic event has ended. They may relive the event through flashbacks or nightmares, may feel sadness, fear, or anger and may experience a sense of detachment or estrangement from others. As a result of these feelings, people with PTSD may avoid situations or people that remind them of the traumatic event, and they may have strong negative reactions to commonplace stimuli such as loud noises or an accidental touch.
About BNC210
Formulated as an oral solid tablet BNC210 is a negative allosteric modulator of the α7 nicotinic acetylcholine receptor under development for the treatment of social anxiety disorder (SAD) and post-traumatic stress disorder (PTSD). BNC210 has been given FDA Fast Track designation for acute treatment of SAD and other anxiety related disorders, and for treatment of PTSD and other trauma and stressor related disorders.
About Bionomics Limited
Bionomics (NASDAQ: BNOX) is a clinical-stage biotechnology company developing novel, potential first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need. Bionomics is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of social anxiety disorder (SAD) and chronic treatment of post-traumatic stress disorder (PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other CNS conditions. Bionomics’ pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need.www.bionomics.com.au
Forward-Looking Statements
Bionomics cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the closing of each tranche of the Company’s private placement financing, the achievement of certain milestones for the various tranches, the timely funding to the Company by each investor in the private placement, the timing, size and expectation of the closing of the private placement; and expectations regarding market conditions, the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds therefrom; and the Company’s expectation that its current cash, cash equivalents, and marketable securities will fund our operations into the third quarter of 2025. The inclusion of forward-looking statements should not be regarded as a representation by Bionomics that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, the Company’s Annual Report on Form 20-F filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Bionomics undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks, uncertainties and other factors is included in Bionomics’ filings with the SEC, copies of which are available from the SEC’s website (www.sec.gov) and on Bionomics’ website (www.bionomics.com.au) under the heading “Investor Center.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Bionomics expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.
FAQ
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