timbetasin topical (RGN-137) / RegeneRx - LARVOL DELTA

Reparative Outcomes in Corneal Infection: Linking Adjunctive Tβ4 Treatment to Nerve Regeneration and Visual Function. (PubMed, Invest Ophthalmol Vis Sci) - "Previous studies have shown that adjunctive thymosin beta-4 (Tβ4) with ciprofloxacin reduces bacterial keratitis severity, enhances wound repair, and promotes a return to homeostasis...Adjunctive Tβ4 treatment promotes meaningful reparative outcomes, restoring both visual function and corneal nerve integrity during P. aeruginosa keratitis. By demonstrating that functional vision and nerve regeneration can be restored with combination therapy, this study highlights the importance of incorporating these end points into therapeutic evaluation and supports further development of Tβ4-based adjunctive strategies."

Journal • Infectious Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • TMSB4X

In vitro evaluation of a bioengineered oxidized alginate-decellularized peritoneal scaffold for sustained thymosin beta-4 delivery in inflammatory skin disorders (SID 2026) - "These results support OACP as a mechanically stable, cytocompatible scaffold enabling sustained topical Tβ4 release, addressing key stability and compatibility barriers that limit peptide-based topical delivery. This platform establishes a preclinical foundation for regenerative peptide delivery strategies in inflammatory skin disease."

Preclinical • Dermatology • Inflammation • TMSB4X

Thymosin beta 4: A potential novel adjunct treatment for bacterial keratitis. (PubMed, Int Immunopharmacol) - "Our previous work has shown that topical Tβ4 as an adjunct to ciprofloxacin treatment reduces inflammatory mediators and inflammatory cell infiltrates (neutrophils/PMN and macrophages) while enhancing bacterial killing and wound healing pathway activation in an experimental model ofP...Adjunctive thymosin beta 4 treatment holds novel therapeutic potential to regulate and, optimally, resolve disease pathogenesis in the cornea and perhaps other infectious and immune-based inflammatory disease. We plan to establish the importance of thymosin beta 4 as a therapeutic agent in conjunction with antibiotics with high impact for immediate clinical development."

Journal • Cataract • Corneal Abrasion • Dry Eye Disease • Infectious Disease • Inflammation • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Transplantation • TMSB4X

Exogenous Thymosin Beta 4 Suppresses IPF-Lung Cancer in Mice: Possibly Associated with Its Inhibitory Effect on the JAK2/STAT3 Signaling Pathway. (PubMed, Int J Mol Sci) - "In this study, we evaluated an animal model of pulmonary fibrosis complicated with LC by implanting LC cells orthotopically into the lungs of mice several days after bleomycin induction of the pulmonary fibrosis in the same mice...The establishment of the IPF-LC animal model will be helpful for the development of drugs for the treatment of IPF-LC. Exogenous rhTβ4 can be potentially used for the treatment of IPF and LC."

Journal • Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • TMSB4X

Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Lenus Therapeutics, LLC | N=15 ➔ 4 | Trial completion date: Jun 2022 ➔ Nov 2021 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2021 ➔ Sep 2021; Business Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Adjunctive Thymosin Beta-4 Treatment Influences MΦ Effector Cell Function to Improve Disease Outcome in Pseudomonas aeruginosa-Induced Keratitis. (PubMed, Int J Mol Sci) - "Collectively, these data provide further evidence that adjunctive Tβ4 + ciprofloxacin treatment offers a more efficacious option for treating bacterial keratitis. Not only does the adjunctive therapy address both the infectious pathogen and corneal wound healing response, but it also influences MΦ infiltration, activation, and function, as revealed by the current study."

Journal • Immunology • Infectious Disease • Inflammation • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • TMSB4X

Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - P2; N=15; Recruiting; Sponsor: Lenus Therapeutics, LLC; Trial completion date: Aug 2020 ➔ Jun 2022; Trial primary completion date: Jun 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date

Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa (clinicaltrials.gov) - P2; N=15; Recruiting; Sponsor: Lenus Therapeutics, LLC; Initiation date: Nov 2019 ➔ Mar 2019

Clinical • Trial initiation date