Aileron Therapeutics Completes Enrollment in Cohort 2 of the Ongoing Phase 1b Clinical Trial Evaluating LTI-03 in Idiopathic Pulmonary Fibrosis (IPF)
Aileron Therapeutics (NASDAQ: ALRN) has completed enrollment in Cohort 2 of its ongoing Phase 1b clinical trial evaluating LTI-03 in Idiopathic Pulmonary Fibrosis (IPF). The trial, which enrolled a total of 24 patients, aims to assess the safety and tolerability of LTI-03 in IPF patients after 14 days of treatment. Cohort 2 will evaluate a high-dose of LTI-03 (5 mg BID).
Previously announced results from Cohort 1, which evaluated a low-dose of LTI-03 (2.5 mg BID), showed positive trends in seven out of eight biomarkers. This suggests a potential therapeutic effect, with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to IPF progression. Three biomarkers showed statistically significant data, reinforcing LTI-03's potential to improve lung function and reverse IPF progression.
Aileron Therapeutics (NASDAQ: ALRN) ha completato l'arruolamento nel Cohorte 2 del suo attuale studio clinico di fase 1b che valuta LTI-03 nella Fibrosi Polmonare Idiopatica (IPF). Lo studio, che ha arruolato un totale di 24 pazienti, ha come obiettivo quello di valutare la sicurezza e la tollerabilità di LTI-03 nei pazienti con IPF dopo 14 giorni di trattamento. Il Cohorte 2 valuterà una dosi alta di LTI-03 (5 mg BID).
I risultati precedentemente annunciati del Cohorte 1, che ha valutato una bassa dose di LTI-03 (2.5 mg BID), hanno mostrato tendenze positive in sette su otto biomarcatori. Questo suggerisce un potenziale effetto terapeutico, con evidenza di ridotta espressione di molteplici proteine profibrotiche prodotte da cellule simili a quelle basali e fibroblasti che contribuiscono alla progressione della IPF. Tre biomarcatori hanno mostrato dati statisticamente significativi, rafforzando il potenziale di LTI-03 di migliorare la funzione polmonare e invertire la progressione dell'IPF.
Aileron Therapeutics (NASDAQ: ALRN) ha completado la inscripción en el Cohorte 2 de su ensayo clínico en fase 1b, que evalúa LTI-03 en la Fibrosis Pulmonar Idiopática (FPI). El ensayo, que incluyó un total de 24 pacientes, tiene como objetivo evaluar la seguridad y tolerabilidad de LTI-03 en pacientes con FPI después de 14 días de tratamiento. El Cohorte 2 evaluará una dosis alta de LTI-03 (5 mg BID).
Los resultados anunciados anteriormente del Cohorte 1, que evaluó una dosis baja de LTI-03 (2.5 mg BID), mostraron tendencias positivas en siete de ocho biomarcadores. Esto sugiere un efecto terapéutico potencial, con evidencia de reducción en la expresión de múltiples proteínas profibrogénicas producidas por células similares a células madre y fibroblastos que contribuyen a la progresión de la FPI. Tres biomarcadores mostraron datos estadísticamente significativos, reforzando el potencial de LTI-03 para mejorar la función pulmonar y revertir la progresión de la FPI.
Aileron Therapeutics (NASDAQ: ALRN)는 코호트 2의 모집을 완료했습니다. 현재 진행 중인 1b 단계 임상 시험에서 아이디오파틱 폐섬유증(IPF)에서 LTI-03을 평가하고 있습니다. 이 시험은 총 24명의 환자를 등록했으며, IPF 환자에게 14일 동안 치료 후 LTI-03의 안전성과 내약성을 평가하는 것을 목표로 하고 있습니다. 코호트 2는 LTI-03의 고용량(5 mg BID)를 평가할 예정입니다.
앞서 발표된 코호트 1의 결과에서는 LTI-03의 저용량(2.5 mg BID)을 평가하였고, 여덟 개의 바이오마커 중 일곱 개에서 긍정적인 경향을 보였습니다. 이는 치료 효과의 잠재성을 시사하며, IPF 진행에 기여하는 기저세포와 섬유아세포가 생산하는 여러 가지 프로섬유성 단백질의 발현이 감소한 증거가 됩니다. 세 개의 바이오마커는 통계적으로 유의미한 데이터를 보여주어 LTI-03이 폐 기능을 개선하고 IPF 진행을 되돌릴 잠재력을 강화했습니다.
Aileron Therapeutics (NASDAQ: ALRN) a terminé le recrutement du Cohorte 2 de son essai clinique de phase 1b en cours évaluant LTI-03 dans la Fibrose Pulmonaire Idiopathique (FPI). L'essai, qui a inclus un total de 24 patients, vise à évaluer la sécurité et la tolérance de LTI-03 chez les patients atteints de FPI après 14 jours de traitement. Le Cohorte 2 évaluera une forte dose de LTI-03 (5 mg BID).
Les résultats précédemment annoncés du Cohorte 1, qui a évalué une faible dose de LTI-03 (2,5 mg BID), ont montré des tendances positives dans sept des huit biomarqueurs. Cela suggère un effet thérapeutique potentiel, avec des preuves d'une expression réduite de multiples protéines profibrotiques produites par des cellules de type basale et des fibroblastes qui contribuent à la progression de la FPI. Trois biomarqueurs ont montré des résultats statistiquement significatifs, renforçant le potentiel de LTI-03 à améliorer la fonction pulmonaire et à inverser la progression de la FPI.
Aileron Therapeutics (NASDAQ: ALRN) hat die Rekrutierung in Kohorte 2 abgeschlossen für seine laufende Phase-1b-Studie zur Bewertung von LTI-03 bei idiopathischer Pulmonalfibrose (IPF). Die Studie, die insgesamt 24 Patienten umfasst hat, zielt darauf ab, die Sicherheit und Verträglichkeit von LTI-03 bei IPF-Patienten nach 14 Tagen Behandlung zu bewerten. Kohorte 2 wird eine Hochdosis von LTI-03 (5 mg BID) bewerten.
Bereits zuvor angekündigte Ergebnisse der Kohorte 1, welche eine Niedrigdosis von LTI-03 (2,5 mg BID) bewertete, zeigten positive Trends bei sieben von acht Biomarkern. Dies deutet auf eine potenzielle therapeutische Wirkung hin, mit Beweisen für eine reduzierte Expression verschiedener profibrotischer Proteine, die von basalähnlichen Zellen und Fibroblasten produziert werden, die zur IPF-Progression beitragen. Drei Biomarker zeigten statistisch signifikante Daten, was das Potenzial von LTI-03 zur Verbesserung der Lungenfunktion und zur Umkehrung der IPF-Progression untermauerte.
- Completed enrollment in Cohort 2 of Phase 1b clinical trial for LTI-03 in IPF
- Positive trends observed in 7 out of 8 biomarkers in Cohort 1 (low-dose)
- Statistically significant data from 3 biomarkers in Cohort 1
- Potential of LTI-03 to improve lung function and reverse IPF progression
- None.
Cohort 2 will evaluate high-dose LTI-03 (5 mg BID)
Previously announced Cohort 1 data demonstrated positive trends in seven of the eight biomarkers evaluated, suggesting a potential therapeutic effect
The last patient was enrolled in mid-September, with a total of 24 patients enrolled in the trial. Eligible patients are randomly assigned (3:1) to receive either inhaled LTI-03 or placebo. The primary objective of the trial is to evaluate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints.
"We are pleased to have completed enrollment in the high-dose cohort of our Phase 1b clinical trial and grateful to all participating patients and investigators," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "Following the positive trend observed in the low-dose cohort, we are excited to assess the safety, tolerability and biomarkers of 5 mg twice daily of inhaled LTI-03 and expect to report topline data in the near term."
In May 2024, the Company announced positive data from Cohort 1 evaluating low-dose LTI-03 (2.5 mg BID). Following inhaled administration of low-dose LTI-03 in 12 patients, a positive trend was observed in seven out of eight biomarkers with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from three biomarkers that was statistically significant, reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF.
About the Phase 1 Clinical Trial of LTI-03
The Phase 1b clinical trial of LTI-03 is a randomized, double-blind, placebo controlled, multi-center, dose escalation trial in patients recently diagnosed with IPF that have not received prior treatment with anti-fibrotic agents for at least two months (NCT05954988). Eligible patients are randomly assigned (3:1) to receive one of two doses of inhaled LTI-03 or placebo. The primary objective of the trial is to investigate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints.
About IPF
IPF is a chronic lung disease characterized by progressive tissue scarring that prevents proper lung function. It is a progressive, fatal, age-associated lung disease affecting approximately 100,000 people in
About LTI-03 and Caveolin-1 (Cav1)
LTI-03 is a seven amino acid peptide, the sequence of which is derived from the caveolin scaffolding domain (CSD), an important binding region of the Cav1 protein. Cav1 normally serves a critical function in the prevention of fibrosis by maintaining a balance between pathways that both initiate and arrest lung repair and cell movement. Through the CSD, caveolin interacts with a large number of signaling molecules, all of which possess a caveolin binding domain region. Cav1 expression is decreased in IPF lung tissues and has been demonstrated to decrease during the fibrotic phase of bleomycin lung injury in mice. Restoring the balance of important biological signals in the lung may not only slow lung function decline but could also restore healthy lung function through the protection of healthy epithelial cells.
About Aileron Therapeutics
Aileron Therapeutics is a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Aileron's lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. Currently, LTI-03 is being evaluated in a Phase 1b clinical trial for the treatment of idiopathic pulmonary fibrosis. Aileron's second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.
References
1 Pergolizzi, Jr., J., LeQuang, J., Varrassi, M., Breve, F., Magnusson, P., Varrassi, G., (2023). What Do We Need to Know About Rising Rates of Idiopathic Pulmonary Fibrosis? A Narrative Review and Update. Springer Nature, Published online 2023 Jan 24. Doi: 10.1007/s12325-022-02395-9.
2 Nathan et al. "Long-term Course and Prognosis of Idiopathic Pulmonary Fibrosis in the New Millennium". Chest Journal Volume 140, ISSUE 1, P221-229, July 2011.
Forward-Looking Statements
This press release may contain forward-looking statements of Aileron Therapeutics, Inc. ("Aileron", the "Company", "we", "our" or "us") within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to: the timing and expectation of the topline results of Cohort 2 of the Phase 1b clinical trial of LTI-03; future expectations, plans and prospects for the Company, the sufficiency of the Company's cash resources; the status and plans for clinical trials, including the timing of data; future product development; and the potential commercial opportunity of LTI-03 and LTI-01. We use words such as "anticipate," "believe," "estimate," "expect," "hope," "intend," "may," "plan," "predict," "project," "target," "potential," "would," "can," "could," "should," "continue," and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties related to, changes in applicable laws or regulations, the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in the Company's drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials or that partial results of a trial such as the Cohort 1 results from the Company's ongoing Phase 1b clinical trial will be indicative of the full results of the trial, the Company's ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the
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