Rein Therapeutics Announces Initiation of RENEW Phase 2 Trial of LTI-03 in Patients with IPF
Rein Therapeutics (NASDAQ: RNTX) has initiated the RENEW Phase 2 trial for its lead drug candidate LTI-03 in idiopathic pulmonary fibrosis (IPF) patients. The trial will enroll approximately 120 patients across 50 global sites, with topline data expected in H1 2026.
The study is designed as a multi-center, randomized, double-blind, placebo-controlled trial testing two dose levels: a low dose cohort (2.5mg BID) and a high dose cohort (5mg BID). The primary endpoint focuses on treatment-emergent adverse events through Week 24, while secondary endpoints include FVC and HRCT measurements.
In the previous Phase 1b trial, LTI-03 demonstrated promising results with positive trends in 7 out of 8 biomarkers in Cohort 2, with 5 showing dose dependence and 4 achieving statistical significance in the combined cohort data.
Rein Therapeutics (NASDAQ: RNTX) ha avviato lo studio di Fase 2 RENEW per il suo principale candidato farmaco LTI-03 nei pazienti con fibrosi polmonare idiopatica (IPF). Lo studio prevede l'arruolamento di circa 120 pazienti in 50 centri a livello globale, con i dati principali attesi nella prima metà del 2026.
Lo studio è progettato come uno studio multicentrico, randomizzato, in doppio cieco e controllato con placebo, che valuta due livelli di dose: un gruppo a dose bassa (2,5 mg BID) e un gruppo ad alta dose (5 mg BID). L'endpoint primario si concentra sugli eventi avversi emergenti dal trattamento fino alla settimana 24, mentre gli endpoint secondari includono misurazioni di FVC e HRCT.
Nel precedente studio di Fase 1b, LTI-03 ha mostrato risultati promettenti con tendenze positive in 7 su 8 biomarcatori nel Gruppo 2, di cui 5 dipendenti dalla dose e 4 con significatività statistica nei dati combinati dei gruppi.
Rein Therapeutics (NASDAQ: RNTX) ha iniciado el ensayo de Fase 2 RENEW para su principal candidato a fármaco LTI-03 en pacientes con fibrosis pulmonar idiopática (FPI). El ensayo inscribirá aproximadamente a 120 pacientes en 50 sitios globales, con datos principales esperados en la primera mitad de 2026.
El estudio está diseñado como un ensayo multicéntrico, aleatorizado, doble ciego y controlado con placebo que evalúa dos niveles de dosis: una cohorte de dosis baja (2,5 mg BID) y una cohorte de dosis alta (5 mg BID). El objetivo primario se centra en los eventos adversos emergentes del tratamiento hasta la semana 24, mientras que los objetivos secundarios incluyen mediciones de FVC y HRCT.
En el ensayo previo de Fase 1b, LTI-03 mostró resultados prometedores con tendencias positivas en 7 de 8 biomarcadores en la Cohorte 2, con 5 dependientes de la dosis y 4 alcanzando significancia estadística en los datos combinados de la cohorte.
Rein Therapeutics (NASDAQ: RNTX)는 특발성 폐섬유증(IPF) 환자를 대상으로 하는 주요 약물 후보인 LTI-03의 RENEW 2상 시험을 시작했습니다. 이 임상시험은 전 세계 50개 사이트에서 약 120명의 환자를 등록할 예정이며, 주요 결과는 2026년 상반기에 발표될 예정입니다.
본 연구는 다기관, 무작위 배정, 이중 맹검, 위약 대조 시험으로 설계되었으며, 두 가지 용량 수준을 평가합니다: 저용량군(2.5mg BID)과 고용량군(5mg BID). 주요 평가 변수는 24주차까지의 치료 관련 이상반응이며, 2차 평가 변수로는 폐 기능 검사(FVC)와 고해상도 전산화단층촬영(HRCT) 측정치가 포함됩니다.
이전 1b상 시험에서 LTI-03은 2군에서 8개 바이오마커 중 7개에서 긍정적인 경향을 보였으며, 그 중 5개는 용량 의존적이고 4개는 군 합산 데이터에서 통계적 유의성을 나타냈습니다.
Rein Therapeutics (NASDAQ : RNTX) a lancé l'essai de Phase 2 RENEW pour son principal candidat médicament LTI-03 chez des patients atteints de fibrose pulmonaire idiopathique (FPI). L'essai prévoit d'inclure environ 120 patients répartis sur 50 sites mondiaux, avec des données principales attendues au premier semestre 2026.
L'étude est conçue comme un essai multicentrique, randomisé, en double aveugle, contrôlé par placebo, testant deux niveaux de dose : une cohorte à faible dose (2,5 mg BID) et une cohorte à forte dose (5 mg BID). Le critère principal porte sur les événements indésirables liés au traitement jusqu'à la semaine 24, tandis que les critères secondaires incluent les mesures de CVF et de HRCT.
Lors de l'essai de Phase 1b précédent, LTI-03 a montré des résultats prometteurs avec des tendances positives dans 7 biomarqueurs sur 8 dans la cohorte 2, dont 5 dépendants de la dose et 4 atteignant une signification statistique dans les données combinées des cohortes.
Rein Therapeutics (NASDAQ: RNTX) hat die RENEW Phase-2-Studie für seinen führenden Wirkstoffkandidaten LTI-03 bei Patienten mit idiopathischer Lungenfibrose (IPF) gestartet. Die Studie wird etwa 120 Patienten an 50 weltweiten Standorten einschließen, wobei die wichtigsten Ergebnisse im ersten Halbjahr 2026 erwartet werden.
Die Studie ist als multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie konzipiert, die zwei Dosierungsstufen testet: eine Niedrigdosis-Kohorte (2,5 mg BID) und eine Hochdosis-Kohorte (5 mg BID). Der primäre Endpunkt konzentriert sich auf behandlungsbedingte unerwünschte Ereignisse bis Woche 24, während sekundäre Endpunkte FVC- und HRCT-Messungen umfassen.
In der vorherigen Phase-1b-Studie zeigte LTI-03 vielversprechende Ergebnisse mit positiven Trends bei 7 von 8 Biomarkern in Kohorte 2, wobei 5 dosisabhängig waren und 4 in den kombinierten Kohortendaten statistische Signifikanz erreichten.
- Positive Phase 1b results with 7 out of 8 biomarkers showing improvement
- Large-scale Phase 2 trial with 120 patients across 50 global sites
- Four biomarkers achieved statistical significance in Phase 1b
- Study allows enrollment of patients on standard of care therapy, expanding potential market
- Final trial results not expected until first half of 2026
- Primary endpoint focuses on safety (adverse events) rather than efficacy
- Will require larger Phase 3 trial after this study if successful
Insights
Rein advances IPF candidate LTI-03 to Phase 2 after encouraging Phase 1b biomarker data; critical efficacy readout expected H1 2026.
Rein Therapeutics has made a significant advancement with its lead asset LTI-03 by initiating the Phase 2 RENEW trial for idiopathic pulmonary fibrosis (IPF), a serious progressive lung disease with limited treatment options. This represents a critical clinical milestone in the drug's development journey.
The dual mechanism of action targeting both alveolar epithelial cell survival and inhibition of profibrotic signaling differentiates LTI-03 from current standard-of-care treatments. The novel Caveolin-1-related peptide approach potentially addresses underlying disease pathophysiology rather than just symptom management.
The Phase 1b results showed promising biomarker data with positive trends in 7/8 biomarkers evaluated, dose-dependent effects in 5 biomarkers, and statistically significant improvements in 4 biomarkers in the combined cohort analysis. This suggests biological activity at the target tissue, which is often challenging to demonstrate in early fibrosis trials.
The well-designed RENEW trial will enroll 120 patients across two dose cohorts (2.5mg BID vs 5mg BID) with appropriate endpoints: safety (primary) and efficacy measurements including FVC (forced vital capacity), ppFVC, and HRCT imaging. The global trial spanning multiple countries (US, UK, Germany, Austria, Poland) should enhance recruitment speed and patient diversity.
The expected topline data in H1 2026 provides a clear development timeline. If successful, this could represent a meaningful advance for IPF patients, especially those who don't respond well to current antifibrotics like nintedanib or pirfenidone. The dry powder inhalation delivery method potentially offers targeted lung delivery while minimizing systemic side effects.
The RENEW Phase 2 trial will enroll up to 120 IPF patients with topline data expected in the first half of 2026
In the previously reported Phase 1b study, LTI-03 showed a positive trend in seven out of eight biomarkers evaluated in Cohort 2, with five showing dose dependence and four showing statistically significant improvement in the combined Cohort 1 and 2 data set
"The initiation of the RENEW trial in patients with IPF marks a significant step forward for Rein as we prepare to ultimately identify and share the potential benefits of LTI-03 on patient lung function," said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. "Following productive FDA interactions and positive topline results from the Phase 1b trial, we have designed our RENEW trial to test the promise of our dual mechanism approach to targeting alveolar epithelial cell survival and the inhibition of profibrotic signaling in this patient population. We are pleased to have begun screening patients for RENEW."
The RENEW trial is a Phase 2 multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of LTI-03 in patients with IPF. In addition, the trial is designed to assess the activity of inhaled dry powder LTI-03 across multiple biomarkers and to measure lung function and the potential for healthy tissue regeneration. The trial is designed to enroll approximately 120 patients diagnosed with IPF within 5 years of screening, who may be receiving standard of care (SoC) antifibrotic therapy, across up to 50 sites globally, including sites in
Patients will be randomized into two blinded placebo-controlled cohorts that will run concurrently. Patients in the low dose cohort will receive 2.5 mg of either LTI-03 or placebo administered twice daily (BID) for a total dose of 5 mg/day, while participants in the high dose cohort will receive 5 mg BID for a total dose of 10 mg/day. The primary endpoint is the incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24. The key secondary endpoint is the efficacy of LTI-03 measured through forced vital capacity (FVC), percent predicted FVC (ppFVC) and high-resolution computer tomography (HRCT), in collaboration with Qureight Ltd. Patients will undergo a 28-day screening period prior to being randomized and entering the 24-week treatment period, with a four-week follow-up.
Rein previously announced positive topline results from Cohort 2 (5 mg BID) of the Phase 1b clinical trial of LTI-03 in IPF, in which a positive trend was observed in seven out of eight biomarkers evaluated, with five biomarkers demonstrating dose-dependent effects and four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2 data set.
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 the
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, or BLM, 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 Rein Therapeutics
Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein'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. LTI-03 has received Orphan Drug Designation in the
References
1Pergolizzi, 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.
2Nathan 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 Rein Therapeutics, Inc. ("Rein", the "Company", "we", "our" or "us") within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to: the planned Phase 2 clinical trial of LTI-03, including with respect to the timing of the trial and the assumption that the Company will raise the funds necessary to conduct the trial]; and future expectations, plans and prospects for the Company. 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: the ability of the Company to obtain the cash resources to fund the RENEW trial and the Company's operations for the necessary periods of time and the Company's ability to manage unplanned cash requirements; 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, including in the Phase 2 clinical trial of LTI-03, or that partial results of a 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; the Company's ability to successfully integrate Qureight's deep-learning platform into its RENEW Phase 2 clinical trial of LTI-03; decisions made by the
Rein Investor Relations & Media Contact:
Argot Partners
rein@argotpartners.com
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FAQ
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