INmune Bio Inc. Completes Enrollment for Phase 2 Trial in Early Alzheimer's Disease
INmune Bio Inc. (NASDAQ: INMB) has completed enrollment for its Phase 2 trial in Early Alzheimer's Disease (AD). The global, blinded, randomized trial, known as AD02, focuses on patients with Early AD and biomarkers of elevated neuroinflammation. The company closed enrollment on September 27, 2024, after determining that ongoing screenings would meet the target of 201 patients. Patients currently in the screening process remain eligible, potentially leading to modest over-enrollment.
CJ Barnum PhD, VP of CNS Drug Development and AD02 trial leader, emphasized the significance of this milestone for INmune Bio, its partners, and trial participants. He noted that exceeding the 201-patient goal will enhance the trial's statistical power, expressing anticipation for the final study results.
INmune Bio Inc. (NASDAQ: INMB) ha completato l'arruolamento per il suo trial di Fase 2 nella Malattia di Alzheimer in fase precoce (AD). Lo studio globale, in cieco e randomizzato, noto come AD02, si concentra su pazienti affetti da AD precoce e da biomarcatori di neuroinfiammazione elevata. L'azienda ha chiuso l'arruolamento il 27 settembre 2024, dopo aver determinato che gli screening in corso avrebbero raggiunto l'obiettivo di 201 pazienti. I pazienti attualmente in fase di screening rimangono idonei, il che potrebbe portare a un modesto sovra-assignamento.
CJ Barnum PhD, Vice Presidente dello Sviluppo Farmaceutico CNS e leader del trial AD02, ha sottolineato l'importanza di questo traguardo per INmune Bio, i suoi partner e i partecipanti allo studio. Ha osservato che superare l'obiettivo di 201 pazienti aumenterà la potenza statistica del trial, esprimendo anticipazione per i risultati finali dello studio.
INmune Bio Inc. (NASDAQ: INMB) ha completado la inscripción para su ensayo de Fase 2 en la Enfermedad de Alzheimer Temprana (EA). El ensayo global, ciego y aleatorio, conocido como AD02, se centra en pacientes con EA temprana y biomarcadores de inflamación neurogénica elevada. La empresa cerró la inscripción el 27 de septiembre de 2024, tras determinar que las evaluaciones en curso alcanzarían la meta de 201 pacientes. Los pacientes que actualmente se encuentran en el proceso de evaluación siguen siendo elegibles, lo que podría llevar a un ligero sobrecupo.
CJ Barnum PhD, VP de Desarrollo de Medicamentos CNS y líder del ensayo AD02, enfatizó la importancia de este hito para INmune Bio, sus socios y los participantes en el ensayo. Señaló que superar la meta de 201 pacientes aumentará la potencia estadística del ensayo, expresando su anticipación por los resultados finales del estudio.
INmune Bio Inc. (NASDAQ: INMB)는 초기 알츠하이머병(AD)에 대한 2상 시험의 모집을 완료했습니다. AD02로 알려진 이 글로벌, 블라인드, 무작위 시험은 초기 AD 환자와 높아진 신경 염증 바이오마커에 초점을 맞추고 있습니다. 회사는 진행 중인 스크리닝이 201명의 환자라는 목표를 충족할 것이라고 판단하여 2024년 9월 27일에 모집을 마감했습니다. 현재 스크리닝 과정에 있는 환자들은 여전히 자격을 갖추고 있으며, 이는 소폭의 과다 모집으로 이어질 수 있습니다.
CJ Barnum 박사, CNS 약물 개발 부사장 및 AD02 시험 책임자는 INmune Bio, 그 파트너 및 시험 참가자들에게 이 이정표의 중요성을 강조했습니다. 그는 201명의 목표를 초과 달성함으로써 시험의 통계적 힘이 강화될 것이며, 최종 연구 결과에 대한 기대감을 표명했습니다.
INmune Bio Inc. (NASDAQ: INMB) a complété le recrutement pour son essai de Phase 2 dans la Maladie d'Alzheimer Précoce (AD). Cet essai mondial, en double aveugle et randomisé, connu sous le nom de AD02, se concentre sur les patients atteints de l'AD précoce et ayant des biomarqueurs d'inflammation neurogène élevée. La société a clôturé le recrutement le 27 septembre 2024, ayant déterminé que les dépistages en cours atteindraient l'objectif de 201 patients. Les patients actuellement en cours de dépistage restent éligibles, ce qui pourrait entraîner un léger dépassement de l'effectif.
CJ Barnum, PhD, VP du Développement des Médicaments CNS et responsable de l'essai AD02, a souligné l'importance de ce jalon pour INmune Bio, ses partenaires et les participants à l'essai. Il a noté que dépasser l'objectif de 201 patients augmentera la puissance statistique de l'essai, exprimant son anticipation pour les résultats finaux de l'étude.
INmune Bio Inc. (NASDAQ: INMB) hat die Einschreibung für seine Phase-2-Studie bei Frühen Alzheimer-Krankheit (AD) abgeschlossen. Die globale, verblindete, randomisierte Studie, bekannt als AD02, konzentriert sich auf Patienten mit frühem AD und Biomarkern für erhöhte Neuroinflammation. Das Unternehmen schloss die Einschreibung am 27. September 2024, nachdem festgestellt wurde, dass die laufenden Screenings das Ziel von 201 Patienten erreichen würden. Patienten, die sich derzeit im Screening-Prozess befinden, bleiben weiterhin berechtigt, was zu einer moderaten Überbuchung führen könnte.
CJ Barnum, PhD, VP für CNS-Arzneimittelentwicklung und Studienleiter der AD02-Studie, betonte die Bedeutung dieses Meilensteins für INmune Bio, seine Partner und die Studienteilnehmer. Er merkte an, dass das Übertreffen des Ziels von 201 Patienten die statistische Aussagekraft der Studie erhöhen wird, und äußerte Vorfreude auf die endgültigen Studienergebnisse.
- Completed enrollment for Phase 2 trial in Early Alzheimer's Disease
- Potential over-enrollment, improving statistical power of the trial
- Achieved significant milestone in drug development process
- None.
Insights
The completion of enrollment for INmune Bio's Phase 2 trial in Early Alzheimer's Disease is a significant milestone, potentially accelerating the development timeline for their novel approach targeting neuroinflammation. With 201 patients targeted and possible over-enrollment, the study's statistical power will be enhanced, increasing the reliability of results.
This trial focuses on patients with biomarkers of elevated neuroinflammation, which aligns with the growing understanding of Alzheimer's as an inflammatory condition. The company's approach of targeting microglial activation represents a distinct strategy in the AD treatment landscape, potentially offering a new avenue for intervention where traditional approaches have struggled.
For investors, this news indicates that INmune Bio is progressing on schedule with a key clinical program. The next critical milestones to watch for will be interim data readouts and, ultimately, the final study results. Positive outcomes could significantly impact the company's valuation and position in the competitive AD market.
The completion of enrollment for INmune Bio's Phase 2 Alzheimer's trial is a positive development for the company's financial outlook. With a market cap of
Meeting enrollment targets on time is important for controlling R&D costs and maintaining investor confidence. The potential over-enrollment suggests strong interest in the trial, which could bode well for future studies or partnerships. However, investors should note that while this milestone is encouraging, it's still a mid-stage trial with significant hurdles ahead.
The Alzheimer's market is vast, with high unmet needs and substantial revenue potential for effective treatments. If INmune Bio's approach proves successful, it could lead to significant value creation. In the near term, watch for any changes in cash burn rate or capital raising activities as the trial progresses to completion.
Boca Raton, Florida, Sept. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), announced today that it closed enrollment for its Phase 2 trial on Friday, 27 September. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on patients with Early AD and biomarkers of elevated neuroinflammation.
Enrollment of new patients into the trial was concluded after the Company determined that there are sufficient patients currently in screening to meet the trial’s target of 201 patients. All patients currently in the screening process will remain eligible to participate in AD02, which will likely result in modest over-enrollment.
"This is a significant milestone for INmune Bio, its partners, and more importantly, for those who have participated in the study,” said CJ Barnum PhD, VP of CNS Drug Development who leads the AD02 trial. “The dedication to excellence from everyone involved in the trial has been truly remarkable. Patient enrollment in excess of the 201-patient goal will improve the power of the trial and we greatly look forward to the final study results."
About AD02
AD02 trial is an international, blinded, randomized Phase 2 trial in patients with Early AD with biomarkers of elevated neuroinflammation. Early AD includes patients with MCI (mild cognitive impairment) and mild AD. Patients must have at least one of four biomarkers of inflammation – elevated CRP, HgbA1c, ESR or ApoE4 allele. Patients receive either XPro™ or placebo (2:1 ratio) for 6 months. The cognitive endpoints are EMACC and CDR. XPro™ is given as a once-a-week subcutaneous injection. For more information on the AD02 clinical trial please visit www.clinicaltrials.gov or www.inmunebio.com.
About Neuroinflammation in AD
Neuroinflammation is chronic inflammation in the brain that is part of the natural aging process called inflammaging. Neuroinflammation is increased due to age, behavioral and genetic factors. Neuroinflammation has been increasingly recognized as a key contributor to the development and progression of neurodegenerative diseases, including Alzheimer's. Neuroinflammation is a key cause of nerve cell death and synaptic dysfunction that causes cognitive decline. Blocking neuroinflammation with XPro™ decreases neurodegeneration and improves synaptic function and promotes remyelination in animal models and is being tested in our Phase 2 clinical trial. There are many publications on the role of neuroinflammation in AD. For example recent review can be found here and here.
About XPro™
XPro™ (XPro1595 or pegipanermin) is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and has a different mechanism of action than currently available TNF inhibitors in that it selectively neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ by inhibiting sTNF, a pro-inflammatory cytokine that plays a major role in driving neuroinflammation, could potentially have substantial beneficial effects in patients with neurologic disease. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage inflammation and immunology biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Early Alzheimer’s disease and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.
Forward-Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contact:
David Moss
Co-founder and Chief Financial Officer
(858) 964-3720
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
FAQ
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