GRI Bio disclosed that its Phase 2a study of the oral iNKT inhibitor GRI‑0621 produced flow‑cytometry data that confirms a shift toward an anti‑fibrotic immune profile in patients with idiopathic pulmonary fibrosis (IPF). The analysis, performed after 12 weeks of treatment, shows increased interferon‑γ and reduced interleukin‑4, –13, –17A, –22 and transforming growth factor‑β in bronchoalveolar lavage and peripheral blood mononuclear cells, supporting the drug’s dual immunomodulatory and anti‑fibrotic mechanisms.
The study enrolled 35 subjects and measured cytokine levels at baseline and after 12 weeks. The data demonstrate that GRI‑0621 not only suppresses iNKT cell activity but also promotes a cytokine milieu associated with fibrosis resolution and lung repair. While the sample size and duration are modest, the findings provide the first mechanistic evidence that the drug can modulate the immune environment in a way that aligns with the clinical endpoints the company is pursuing.
IPF remains a disease with limited treatment options; only pirfenidone and nintedanib are approved, and both have notable side‑effect profiles. The projected market for IPF therapies is $5.46 billion by 2030, underscoring the commercial opportunity for a drug that can address the unmet need for safe, tolerable, and truly effective therapy. GRI‑0621’s dual action—blocking iNKT‑cell–driven inflammation while directly targeting fibrotic pathways—positions it as a potentially transformative option in this space.
CEO Marc Hertz highlighted the significance of the data, noting that the results “continue to demonstrate a compelling profile, combining favorable safety and tolerability with a dual mechanism of action as both an immunomodulator and an anti‑fibrotic agent.” The company also confirmed that its stockholders’ equity now exceeds the Nasdaq minimum requirement of $2.5 million, a threshold that was met following a public offering in December 2025.
Financially, GRI Bio remains a clinical‑stage company with ongoing losses—net losses of $3.35 million in Q3 2025 and $1.948 million in Q4 2024. The new data reinforce the company’s strategy to advance GRI‑0621 through the 505(b)(2) regulatory pathway, with the goal of achieving regulatory approval and eventual commercialization. The milestone is expected to strengthen investor confidence in the company’s long‑term trajectory, even as it continues to raise capital to fund its pipeline and clinical development.
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