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RNTX 资讯
RNTX 事件
Rein Therapeutics Receives FDA Fast Track Designation for LTI-03
Rein Therapeutics announced that the FDA has granted Fast Track designation to LTI-03 for the treatment of idiopathic pulmonary fibrosis.
Rein Therapeutics Updates on LTI-03 Clinical Trial Progress
Rein Therapeutics provided an update on its ongoing Phase 2 RENEW clinical trial evaluating LTI-03 for the treatment of idiopathic pulmonary fibrosis. The company said, "The Company has enrolled 8 patients in its RENEW trial to date, with 2 additional patients expected to be enrolled this week. Enrollment in the study began in March 2026, and the Company continues to add patients on a regular basis. Rein also continues to make progress on expanding its global clinical trial footprint. Clinical trial sites are currently active in the United States, Australia, and Poland, with additional countries - including the United Kingdom and Germany - expected to open in the near term. The Company plans to continue activating more new sites to support ongoing enrollment."
Rein Therapeutics Doses First Patient in LTI-03 Clinical Trial
Rein Therapeutics dosed the first patient in its Phase 2 clinical trial evaluating LTI-03 for idiopathic pulmonary fibrosis, a progressive and fatal lung disease with limited treatment options. The Phase 2 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and impact to lung function and structure of LTI-03, an inhaled therapy intended to regulate multiple fibrosis pathways and preserve lung function. The study will enroll approximately 120 patients across placebo, low dose, and high dose groups at clinical sites in five countries. In addition to safety and tolerability, the trial will closely monitor changes in lung function, including forced vital capacity, a key tool in the measurement of respiratory health in patients with IPF. Rein expects to enroll patients through mid-2027, with interim data anticipated in the second half of 2026.
Rein Therapeutics Receives Orphan Drug Designation for LTI-03
Rein Therapeutics announced that it has received orphan drug designation from the European Medicines Agency, EMA, for LTI-03, its lead drug candidate aimed at preserving lung function in patients with idiopathic pulmonary fibrosis, IPF. The designation follows a positive opinion from the EMA's Committee for Orphan Medicinal Products, COMP, and subsequent adoption by the European Commission.
Rein Therapeutics Reveals Publication Regarding LTI-03
Rein Therapeutics announced that a new preprint has been posted to medRxiv describing clinical and translational findings from an inhaled, dose-escalation study of Rein's lead drug candidate, LTI-03, in idiopathic pulmonary fibrosis, IPF. The preprint, titled "Inhaled LTI-03 for Idiopathic Pulmonary Fibrosis: A Randomized Dose Escalation Study." The report describes how inhaled LTI-03 was evaluated in IPF patients to assess safety, pharmacokinetics, and biological activity. According to the authors, LTI-03 was generally well tolerated, and samples collected from treated patients showed reductions in multiple fibrosis-associated biomarkers. These biomarkers include proteins and inflammatory signals linked to disease progression, offering evidence that the drug is reaching the lung and engaging its intended targets.
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