Nintedanib esylate

Data presented at the 2025 American Thoracic Society (ATS) International Conference Pre-clinical and interim clinical results underscore GRI-0621’s potential to have both anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis Results from 6-week interim analysis (n=24) in ongoing Phase 2a study of GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) anticipated in Q2 2025 May 22, 2025 -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the presentation of positive preclinical data demonstrating its lead program GRI-0621 has anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis. The data was presented by Marc Hertz, PhD, Chief Executive Officer of GRI Bio in the poster titled, “Inactivation of iNKT Cells After the Inflammatory Phase Leads to Significant Inhibition of Fibroblast Activation and Fibrosis in a Model of Pulmonary Fibrosis,” as part of the D21 - IMMUNOLOGICAL INSIGHTS IN LUNG INFLAMMATION AND REPAIR session at the 2025 ATS International Conference held on Wednesday, May 21, 2025. “We continue believe GRI-0621 is a promising potential treatment option for IPF, an indication where there remains significant unmet need. Our growing body of pre-clinical results continue to bolster our understanding of the role of iNKT cell activity in driving pulmonary fibrosis and further support our ongoing Phase 2a study examining the safety and tolerability of GRI-0621 and its effect on various biomarkers in IPF patients. We remain encouraged by the progress made in our Phase 2a biomarker study and look forward to reporting additional data this year,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. The presented data highlights results from biochemical, qPCR and immunohistochemistry analyses, used to investigate whether iNKT cell inactivation during the fibrotic phase resolves lung injury, fibroblast activation, and fibrosis in the murine bleomycin model of pulmonary fibrosis. In a therapeutic regimen of the bleomycin-induced fibrosis model, orally administered GRI-0621 after completion of the inflammatory phase (Day 7), significantly inhibits lung injury and several important fibrotic cellular and molecular drivers of lung disease, including fibroblast activation and fibrosis. GRI-0621 demonstrated to impact key innate and adaptive cell activity, cytokine production, myofibroblast activation, and ECM deposition and fibrosis. GRI-0621 inhibition of iNKT cell activity is therapeutic in treatment models of pulmonary fibrosis and performs as well or better than the approved drug nintedanib. GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. GRI-0621 is currently being assessed in a 12-week, double-blind, randomized, placebo-controlled study in patients with IPF to assess the safety and tolerability of GRI-0621. In addition, the effect of GRI-0621 on a number of biomarkers both from the blood and bronchoalveolar lavage (BAL) will be evaluated. These include several biomarkers associated with disease progression, NKT cell and other immune cell numbers and activity, differential gene expression, as well as pulmonary function tests. As previously announced, the pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol. Hyperlipidemia, as assessed by LDL, HDL and triglyceride (TG) levels, was not seen in the 12 patients assessed at the 2-week visit. There were no meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621. The interim analysis committee recommended the study should continue as planned. The interim results show that GRI-0621’s receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks. Additionally, interim biomarker results from the first 12 subjects at 2 weeks were reviewed by the IDMC and determined that the change from baseline in PRO-C3 of GRI-0621-treated patients compared to placebo patients is suggestive of anti-fibrotic effect. Based on the available interim data reviewed, the IDMC has recommended the Phase 2a study evaluating GRI-0621 to continue as planned as there are no safety concerns seen to date. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025. GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of Natural Killer T (“NKT”) cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 diverse NKT (“dNKT”) agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline. The content above comes from the network. if any infringement, please contact us to modify.

CAMBRIDGE, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company developing inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that management will participate in the Jefferies Global Healthcare Conference on June 3, 2025. Format:1x1 Meetings Date:Tuesday, June 3, 2025 Location:New York Marriott Marquis, New York, NY Participants:Douglas Carlson, CFO & CBO; Craig Conoscenti, SVP, Clinical Development About Avalyn PharmaAvalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity, and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source by safely delivering treatments directly into the lungs, thereby improving tolerability by decreasing systemic exposure and improving efficacy by increasing lung exposure. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn. Investor Contact:Alex StrausTHRUST Strategic Communicationsalex@thrustsc.comir@avalynpharma.com Media Contact:media@avalynpharma.com