Rein Therapeutics Announces First Patient Dosed in RENEW Phase 2 Trial of LTI-03 in Patients with IPF
Rein Therapeutics (NASDAQ: RNTX) has announced the dosing of its first patient in the RENEW Phase 2 trial of LTI-03, targeting idiopathic pulmonary fibrosis (IPF). The trial will evaluate the safety, tolerability, and efficacy of LTI-03, a novel Caveolin-1-related peptide treatment.
The study is designed as a multi-center, randomized, double-blind, placebo-controlled trial that aims to enroll 120 patients across 50 global sites. Participants must have been diagnosed with IPF within 5 years of screening. The trial's primary endpoint focuses on treatment-emergent adverse events through Week 24, while secondary endpoints measure efficacy through FVC, ppFVC, and HRCT metrics. Rein is collaborating with IQVIA for enrollment, and topline interim data is expected in H1 2026.
Rein Therapeutics (NASDAQ: RNTX) ha annunciato la somministrazione della prima dose al primo paziente nel trial di Fase 2 RENEW con LTI-03, volto a trattare la fibrosi polmonare idiopatica (IPF). Lo studio valuterà la sicurezza, la tollerabilità e l'efficacia di LTI-03, un nuovo trattamento a base di un peptide correlato a Caveolina-1.
Lo studio è progettato come uno studio multicentrico, randomizzato, in doppio cieco e controllato con placebo, con l'obiettivo di arruolare 120 pazienti in 50 siti globali. I partecipanti devono essere stati diagnosticati con IPF entro 5 anni dalla valutazione iniziale. L'endpoint primario del trial riguarda gli eventi avversi emergenti durante il trattamento fino alla settimana 24, mentre gli endpoint secondari misurano l'efficacia tramite FVC, ppFVC e parametri HRCT. Rein collabora con IQVIA per l'arruolamento e si prevedono i dati preliminari principali nella prima metà del 2026.
Rein Therapeutics (NASDAQ: RNTX) ha anunciado la dosificación de su primer paciente en el ensayo de Fase 2 RENEW con LTI-03, dirigido a la fibrosis pulmonar idiopática (IPF). El ensayo evaluará la seguridad, tolerabilidad y eficacia de LTI-03, un nuevo tratamiento basado en un péptido relacionado con Caveolina-1.
El estudio está diseñado como un ensayo multicéntrico, aleatorizado, doble ciego y controlado con placebo, con el objetivo de reclutar a 120 pacientes en 50 sitios a nivel mundial. Los participantes deben haber sido diagnosticados con IPF dentro de los 5 años previos a la evaluación. El objetivo principal del ensayo es evaluar los eventos adversos emergentes durante el tratamiento hasta la semana 24, mientras que los objetivos secundarios miden la eficacia mediante FVC, ppFVC y métricas HRCT. Rein colabora con IQVIA para el reclutamiento y se esperan datos provisionales principales en la primera mitad de 2026.
Rein Therapeutics (NASDAQ: RNTX)가 특발성 폐섬유증(IPF)을 대상으로 하는 RENEW 2상 임상시험에서 첫 환자 투약을 발표했습니다. 본 임상시험은 새로운 Caveolin-1 관련 펩타이드 치료제인 LTI-03의 안전성, 내약성 및 효능을 평가합니다.
이 연구는 다기관, 무작위 배정, 이중 맹검, 위약 대조 임상시험으로 설계되었으며, 전 세계 50개 사이트에서 120명의 환자를 모집할 예정입니다. 참여자는 검사 시점으로부터 5년 이내에 IPF 진단을 받아야 합니다. 1차 평가변수는 24주차까지의 치료 중 발생하는 이상반응이며, 2차 평가변수는 FVC, ppFVC, HRCT 지표를 통한 효능 평가입니다. Rein은 IQVIA와 협력하여 환자 모집을 진행하며, 주요 중간 결과는 2026년 상반기에 발표될 예정입니다.
Rein Therapeutics (NASDAQ : RNTX) a annoncé l'administration de la première dose à son premier patient dans l'essai de phase 2 RENEW portant sur LTI-03, ciblant la fibrose pulmonaire idiopathique (IPF). Cet essai évaluera la sécurité, la tolérabilité et l'efficacité de LTI-03, un nouveau traitement à base d'un peptide lié à la Caveoline-1.
L'étude est conçue comme un essai multicentrique, randomisé, en double aveugle et contrôlé par placebo, visant à recruter 120 patients répartis sur 50 sites à travers le monde. Les participants doivent avoir été diagnostiqués avec une IPF dans les 5 ans précédant le dépistage. Le critère principal porte sur les événements indésirables liés au traitement jusqu'à la semaine 24, tandis que les critères secondaires mesurent l'efficacité via les paramètres FVC, ppFVC et HRCT. Rein collabore avec IQVIA pour le recrutement, et les données intermédiaires principales sont attendues au premier semestre 2026.
Rein Therapeutics (NASDAQ: RNTX) hat die Dosierung des ersten Patienten in der RENEW Phase-2-Studie mit LTI-03 zur Behandlung der idiopathischen Lungenfibrose (IPF) bekannt gegeben. Die Studie wird die Sicherheit, Verträglichkeit und Wirksamkeit von LTI-03, einem neuartigen Caveolin-1-assoziierten Peptid, untersuchen.
Die Studie ist als multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie konzipiert und plant die Einschreibung von 120 Patienten an 50 Standorten weltweit. Die Teilnehmer müssen innerhalb von 5 Jahren vor der Screening-Untersuchung mit IPF diagnostiziert worden sein. Der primäre Endpunkt fokussiert sich auf behandlungsbedingte unerwünschte Ereignisse bis Woche 24, während sekundäre Endpunkte die Wirksamkeit anhand von FVC, ppFVC und HRCT-Messungen bewerten. Rein arbeitet für die Rekrutierung mit IQVIA zusammen, und Zwischenergebnisse werden für das erste Halbjahr 2026 erwartet.
- First patient dosed in Phase 2 trial, marking significant clinical progress
- Large-scale trial planned with 120 patients across 50 global sites
- Collaboration with leading clinical research provider IQVIA for enrollment
- Results not expected until first half of 2026
- Early-stage clinical trial with no guaranteed success
- Competing with existing standard of care treatments in IPF market
Insights
Rein's Phase 2 IPF trial initiation is a significant development milestone, though efficacy results won't be available until 2026.
Rein Therapeutics has reached a crucial clinical development milestone with the dosing of the first patient in their Phase 2 RENEW trial evaluating LTI-03 for idiopathic pulmonary fibrosis (IPF). This trial represents a significant step forward in the company's development timeline for their lead asset. The 120-patient study is designed as a randomized, double-blind, placebo-controlled trial - the gold standard in clinical research - which will provide robust data on the compound's efficacy.
The trial design is particularly noteworthy as it allows for enrollment of patients who may already be receiving standard of care antifibrotic therapy. This pragmatic approach acknowledges the reality that many IPF patients are already on treatment and could potentially benefit from additional therapeutic options. The primary endpoint focuses on safety (treatment-emergent adverse events through Week 24), which is appropriate for this stage of development, while key secondary endpoints include meaningful efficacy measurements like forced vital capacity (FVC) - the established regulatory endpoint for IPF trials.
The collaboration with IQVIA for trial enrollment is strategically sound, as IQVIA's extensive site network should facilitate more efficient patient recruitment across up to 50 global sites. However, investors should note that topline interim data isn't expected until first half of 2026, indicating a considerable waiting period before understanding LTI-03's potential clinical benefit. The mechanism of LTI-03 as a Caveolin-1-related peptide represents a novel approach in the IPF space, potentially differentiating it from current standard of care options if efficacy is demonstrated.
Trial is evaluating the safety, tolerability, and efficacy of LTI-03 in idiopathic pulmonary fibrosis (IPF) with topline interim data expected in the first half of 2026
"We are pleased to have dosed the first patient in our RENEW Phase 2 trial of LTI-03 following initiation of the trial. We are profoundly focused on our mission to rein in fibrosis and look forward to continuing our momentum in the clinic," said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. "We are encouraged by the strong body of evidence supporting LTI-03 as a potentially innovative treatment for patients with IPF whose needs are unmet by the current standard of care (SoC). I am grateful to our team at Rein, the patients, investigators, and staff participating in our trial for the efficient progress that we are making."
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. Rein is collaborating with IQVIA (NYSE: IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, on enrollment for the trial. RENEW is designed to enroll approximately 120 patients diagnosed with IPF within 5 years of screening, who may be receiving SoC antifibrotic therapy, across up to 50 sites globally. The primary endpoint for the trial 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. Topline interim data from RENEW is expected in the first half of 2026.
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
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 RENEW 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; the therapeutic potential of LTI-03; 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 Phase 2 trial through its completion and the Company's operations for the anticipated periods 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 RENEW Phase 2 trial, 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 Ltd.'s deep-learning platform into the RENEW Phase 2 trial; decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; as well as the risks and uncertainties discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024, which is on file with the United States Securities and Exchange Commission (the "SEC") and in subsequent filings that the Company files with the SEC. These forward-looking statements should not be relied upon as representing the Company's view as of any date after the date of this press release, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Rein Investor Relations & Media Contact:
Argot Partners
rein@argotpartners.com
212-600-1902
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