GRI-0803 / GRI Bio - LARVOL DELTA

GRI Bio Bolsters Intellectual Property Portfolio with Granting of Two Global Patents for Europe and Japan (GlobeNewswire) - "GRI Bio...today announced the granting of two global patents....Europe patent application No. 19,166,502 titled, 'Oxygenated Amino- or Ammonium-Containing Sulfonic Acid, Phosphonic Acid and Carboxylic Acid Derivatives and Their Medical Use.' The patent claims include coverage of GRI-0803, the Company’s novel activator of human type 2 diverse NKT (dNKT) cells in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus (SLE). Japan application No. 2023-000750 titled, 'Prevention and Treatment of Inflammatory Conditions.' This patent covers claims including compositions and methods for modulating dNKT and/or iNKT cells in the prevention and treatment of inflammatory conditions...."

Patent • Immunology • Inflammatory Arthritis • Systemic Lupus Erythematosus

GRI Bio Announces European Patent Office Issued a Decision to Grant Notice for Patent Covering GRI-0803 and Its Library of 500+ Proprietary Compounds (GlobeNewswire) - "GRI Bio, Inc...today announced that European Patent Office (EPO) has issued a decision to grant notice for patent application number 19,166,502 titled, 'Oxygenated Amino- or Ammonium-Containing Sulfonic Acid, Phosphonic Acid and Carboxylic Acid Derivatives and Their Medical Use.' Based on the intention to grant notice, the Company expects the EPO to issue a patent January 16, 2025...The patent claims include coverage of GRI-0803, the Company’s novel activator of human type 2 NKT cells in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus (SLE)...the GRI-0803 IND-enabling and Phase1 program will continue in 2025."

IND • New P1 trial • Patent • Immunology • Lupus • Systemic Lupus Erythematosus

GRI Bio Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "GRI-0621 interim data readout of Phase 2a biomarker study on track for Q4 2024 and topline data on track for Q1 2025...The Company is currently focusing its available resources on GRI-0621, but, pending additional funding, the GRI-0803 IND-enabling and Phase1 program will continue in 2025."

Commercial • P2a data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Systemic Lupus Erythematosus

NKT cell activators potential SLE treatment, preclinical data show (Lupus News Today) - "GRI-0124, an oral small molecule being developed to activate natural killer T-cells, or NKT cells, and keep autoimmune attacks in check eased inflammation and prolonged survival in a mouse model of SLE, the company said...The company’s second small molecule candidate, GRI-0803, is similar in structure to GRI-0124 and has been found to be safe in preclinical studies. The way GRI-0803 is taken up and eliminated from the body supports the use of once-daily dosing in future studies...GRI-0124 and GRI-0803 appear to 'have the potential to target earlier in the inflammatory cascade to interrupt disease progression,' said Chaturvedi, who presented the data at the 14th International Congress on Autoimmunity...'We remain encouraged by GRI-0803’s potential and are working in earnest to validate bioanalytical methods, complete cGMP manufacturing, and complete toxicology studies in order to file our IND for GRI-0803 in the second half of 2024'..."

IND • Preclinical • Systemic Lupus Erythematosus

GRI Bio (NASDAQ: GRI) Participates in Virtual Investor “What This Means” Segment Highlighting Positive Preclinical Data from Idiopathic Pulmonary Fibrosis (IPF) and Systemic Lupus Erythematosus (SLE) Programs (GlobeNewswire) - "Expected GRI-0803 Upcoming Milestones: Q3 2024: Complete IND-enabling studies. Q3 2024: File IND and launch Phase 1a/b. Q4 2024: Report Phase 1a single ascending dose (SAD) study topline results. Q4 2024: Report Phase 1b multiple ascending dose (MAD) study topline results."

IND • New P1 trial • P1 data • Preclinical • Systemic Lupus Erythematosus

GRI Bio Presents Positive Preclinical Data from Pipeline of NKT Cell Modulators in Development for the Treatment of Systemic Lupus Erythematosus (SLE) (GlobeNewswire) - "Once-weekly GRI-0124: Inhibited pro-inflammatory cytokines and signaling pathways in NZBWF1 mice; Decreased pDC accumulation and MHC class II expression;...Reduced renal cellular infiltration and fibrosis....GRI-0803 has demonstrated: Chemistry backbone based on type 2 GRI-0124; <400g/mol; Favorable solubility profile; Excellent bioavailability; PK profile supporting q.d. administration orally....Data presented at the 14th International Congress on Autoimmunity."

Preclinical • Systemic Lupus Erythematosus

GRI Bio Reports Full Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Expected GRI-0803 Upcoming Milestones: H1 2024: Complete IND-enabling studies. H1 2024: File IND and launch Phase 1a/b. Q3 2024: Report Phase 1a single ascending dose (SAD) study topline results. Q4 2024: Report Phase 1b multiple ascending dose (MAD) study topline results."

IND • New P1 trial • P1 data • Preclinical • Lupus • Systemic Lupus Erythematosus

Vallon Pharmaceuticals and GRI Bio Enter into Merger Agreement with Goal of Advancing Innovative Pipeline of NKT Cell Regulators (GlobeNewswire) - "Vallon Pharmaceuticals...today announced that they have entered into a definitive agreement (the 'Merger Agreement') pursuant to which GRI Bio will merge with a wholly-owned subsidiary of Vallon in an all-stock transaction (the 'Merger'). The combined company will focus on advancing GRI Bio’s innovative pipeline of NKT cell regulators for the treatment of inflammatory, fibrotic and autoimmune diseases. Following the closing of the Merger, the combined company is expected to operate under the name 'GRI Bio, Inc'....GRI Bio is planning to launch a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF with data expected in the second quarter of 2024. GRI Bio’s second asset in development, GRI-0803, is a novel activator of human NKT II cells in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus. GRI Bio expects to launch a Phase 1 study in 2023."

Biomarker • M&A • New P1 trial • New P2a trial • Idiopathic Pulmonary Fibrosis • Immunology • Systemic Lupus Erythematosus