Rein Therapeutics Wins U.K. Approval to Launch Phase 2 Clinical Trial of LTI-03 in Idiopathic Pulmonary Fibrosis
Rein Therapeutics (NASDAQ: RNTX) has received approval from the UK's MHRA to begin its Phase 2 "RENEW" clinical trial for LTI-03, a first-in-class therapy targeting idiopathic pulmonary fibrosis (IPF). The trial will evaluate 120 patients across two dose groups against placebo, with initial data expected in 2026.
LTI-03 is designed to target fibrosis while protecting lung regeneration capability, potentially offering a breakthrough treatment for IPF, a serious lung disease with a median survival of just 3-5 years after diagnosis. The 24-week trial will primarily assess safety and tolerability, with secondary endpoints including lung function and fibrosis progression measures.
Rein Therapeutics (NASDAQ: RNTX) ha ottenuto l'autorizzazione dall'MHRA del Regno Unito per avviare la sperimentazione di Fase 2 denominata "RENEW" per LTI-03, una terapia di prima classe contro la fibrosi polmonare idiopatica (IPF). Lo studio valuterà 120 pazienti suddivisi in due gruppi di dose rispetto al placebo; i primi dati sono attesi nel 2026.
LTI-03 è progettato per contrastare la fibrosi proteggendo al contempo la capacità rigenerativa del polmone, offrendo un potenziale trattamento innovativo per l'IPF, una grave malattia polmonare con una sopravvivenza mediana di appena 3-5 anni dalla diagnosi. Lo studio di 24 settimane valuterà principalmente sicurezza e tolerabilità; gli endpoint secondari includono misure della funzione polmonare e della progressione della fibrosi.
Rein Therapeutics (NASDAQ: RNTX) ha recibido la aprobación de la MHRA del Reino Unido para iniciar el ensayo clínico de Fase 2 "RENEW" con LTI-03, una terapia de primera clase dirigida a la fibrosis pulmonar idiopática (EPID). El ensayo evaluará a 120 pacientes en dos grupos de dosis frente a placebo; se esperan los primeros datos en 2026.
LTI-03 está diseñado para combatir la fibrosis protegiendo la capacidad de regeneración pulmonar, lo que podría suponer un avance terapéutico para la EPID, una enfermedad pulmonar grave con una supervivencia media de solo 3-5 años tras el diagnóstico. El ensayo de 24 semanas evaluará principalmente la seguridad y la tolerabilidad, y los objetivos secundarios incluirán medidas de la función pulmonar y la progresión de la fibrosis.
Rein Therapeutics (NASDAQ: RNTX)가 영국 MHRA로부터 2상 임상시험 "RENEW"을 시작할 승인을 받았습니다. 대상은 특발성 폐섬유증(IPF)을 표적하는 첫 번째 계열 치료제인 LTI-03입니다. 본 시험은 위약 대조군과 비교해 두 가지 용량군에서 120명의 환자를 평가하며 초기 결과는 2026년에 예상됩니다.
LTI-03은 폐 재생 능력을 보호하면서 섬유화를 억제하도록 설계되어 진단 후 중앙생존기간이 3~5년에 불과한 중증 폐질환인 IPF에 대한 획기적 치료가 될 가능성이 있습니다. 24주 동안 진행되는 이 시험은 주로 안전성과 내약성을 평가하고, 2차 목표로 폐 기능 및 섬유화 진행 측정치를 포함합니다.
Rein Therapeutics (NASDAQ: RNTX) a obtenu l'autorisation de la MHRA britannique pour lancer son essai clinique de phase 2 « RENEW » portant sur LTI-03, une thérapie de première classe ciblant la fibrose pulmonaire idiopathique (FPi). L'essai évaluera 120 patients répartis en deux groupes de dose contre placebo ; les premières données sont attendues en 2026.
LTI-03 est conçu pour cibler la fibrose tout en préservant la capacité de régénération pulmonaire, offrant potentiellement une avancée thérapeutique pour la FPi, une maladie pulmonaire grave avec une survie médiane de seulement 3 à 5 ans après le diagnostic. L'essai de 24 semaines évaluera principalement la sécurité et la tolérabilité ; les critères secondaires incluent les mesures de la fonction pulmonaire et la progression de la fibrose.
Rein Therapeutics (NASDAQ: RNTX) hat von der britischen MHRA die Zustimmung erhalten, die Phase‑2-Studie "RENEW" mit LTI-03 zu starten – einer First‑in‑class‑Therapie gegen idiopathische Lungenfibrose (IPF). Die Studie wird 120 Patienten in zwei Dosisgruppen gegen Placebo untersuchen; erste Daten werden für 2026 erwartet.
LTI-03 zielt darauf ab, die Fibrose zu hemmen und gleichzeitig die regenerativen Fähigkeiten der Lunge zu schützen, und könnte damit einen Durchbruch in der Behandlung der IPF darstellen, einer schweren Lungenerkrankung mit einer mittleren Überlebenszeit von nur 3–5 Jahren nach Diagnose. Die 24‑wöchige Studie bewertet primär Sicherheit und Verträglichkeit; sekundäre Endpunkte beinhalten Lungenfunktions‑ und Fibroseverlaufsmaße.
- Received MHRA approval for Phase 2 clinical trial, advancing development pipeline
- Novel first-in-class therapy targeting significant unmet medical need in IPF
- Large trial size of 120 patients indicates robust study design
- Potential to both slow disease progression and restore lung cell function
- Initial data not expected until 2026, indicating long development timeline
- Early-stage clinical trial with no guarantee of success
- Will require significant resources to complete 120-patient trial
Insights
Rein's UK approval for Phase 2 IPF trial represents significant clinical advancement for a serious disease with few treatment options.
The MHRA's authorization for Rein Therapeutics to begin its Phase 2 RENEW trial marks a critical regulatory milestone for LTI-03's clinical development pathway. IPF represents a substantial unmet medical need with its 3-5 year median survival post-diagnosis and limited effective treatments.
LTI-03's dual mechanism targeting both fibrosis inhibition and tissue regeneration sets it apart from current standards of care which typically only slow disease progression. This novel approach could potentially address the fundamental pathology rather than just managing symptoms.
The trial design includes 120 patients across multiple dose groups with a 24-week treatment period. While the primary endpoints focus on safety and tolerability – appropriate for this stage of development – the secondary endpoints examining lung function and fibrosis progression via imaging will provide crucial efficacy signals.
The timeline with data expected in 2026 is relatively efficient for a Phase 2 pulmonary disease program. The company appears to be moving systematically through development while maintaining scientific rigor through placebo controls.
This advancement positions Rein strategically in the orphan pulmonary space where successful therapies can command premium pricing and exclusivity benefits. For a condition affecting hundreds of thousands globally with high mortality, even modest efficacy could translate to significant clinical and commercial value.
AUSTIN, Aug. 19, 2025 (GLOBE NEWSWIRE) -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the Company to initiate its Phase 2 “RENEW” clinical trial of LTI-03, the Company’s lead drug candidate for idiopathic pulmonary fibrosis (IPF).
IPF is a serious, progressive lung disease that affects hundreds of thousands of people worldwide. It scars the lungs, leaving patients short of breath and with limited treatment options. Median survival after diagnosis is just 3–5 years.
Rein’s LTI-03 is a first-in-class therapy that is designed to directly target fibrosis while also protecting the lung’s ability to regenerate healthy tissue. If successful, it could represent a major breakthrough in how pulmonary fibrosis is treated.
Brian Windsor, Chief Executive Officer of Rein Therapeutics, commented, “This MHRA approval marks an important milestone not only for Rein, but also for patients living with IPF. We are now working towards patient recruitment in the U.K., advancing LTI-03 into the next stage of development. Our approach is designed not only to slow disease progression, but also to preserve, and potentially restore, the lung cells that are critical to everyday breathing and quality of life. We believe LTI-03 has the potential to transform outcomes for patients while also creating substantial value for our shareholders.”
Next Steps
The RENEW trial is expected to enroll up to 120 patients worldwide, evaluating two dose groups of LTI-03 against a placebo. The primary objective of the trial is to assess safety and tolerability over 24 weeks of treatment. Secondary endpoints will include measures of lung function and imaging-based assessments of fibrosis progression.
Rein is actively working with clinical sites in the UK to begin patient recruitment soon, with initial data expected in 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 U.S. and is in clinical development. Rein'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 U.S. and E.U. and Fast Track Designation in the U.S.
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 expectations for the Company’s LTI-03 product candidate, the planned UK Phase 2 clinical trial of LTI-03 and the initial data readouts from the planned UK clinical trial. 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 (i) the risk that the Company may not be able to successfully undertake the planned UK Phase 2 clinical trial of LTI-03, (ii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iii) the risk that the Company may not be able to obtain additional working capital with which to initiate and complete planned UK clinical trial, (iv) the risk that the Company may not be able to announce initial data readouts from the planned UK clinical trial in 2026 or, if it is able to do so, that the data may not be favorable and (v) those other risks disclosed 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:
Investor Relations
IR@ReinTx.com
FAQ
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