GRI Bio Presents Positive Preclinical Data Demonstrating Lead Program GRI-0621 Reduces the Important Inflammatory and Fibrotic Drivers in Idiopathic Pulmonary Fibrosis (IPF)
GRI Bio announced positive preclinical data for its lead program GRI-0621 in treating Idiopathic Pulmonary Fibrosis (IPF). The data, presented at the 2024 ATS International Conference, showed that GRI-0621 significantly reduced fibrosis and lung inflammation in a mouse model by inhibiting type 1 invariant Natural Killer T (iNKT) cell activity. The company is advancing to a Phase 2a biomarker study, with interim data expected in Q3 2024 and topline results in Q4 2024. This study will evaluate the safety, tolerability, and biomarker effects of GRI-0621 in IPF patients.
GRI-0621's mechanism involves inhibiting iNKT cells, which are pivotal in the early stages of fibrotic disease. Existing IPF treatments are and come with significant side effects, making GRI-0621 a promising candidate. GRI Bio aims to leverage the 505(b)(2) regulatory pathway to accelerate the drug's development.
- Positive preclinical data showing GRI-0621 reduces fibrosis and lung inflammation in IPF.
- GRI-0621 inhibits iNKT cell activity, important in fibrotic disease progression.
- Advancement to Phase 2a biomarker study with interim data expected in Q3 2024 and topline results in Q4 2024.
- Potential to fill a significant gap in IPF treatment, with current options being and having severe side effects.
- Plans to leverage the 505(b)(2) regulatory pathway for faster development.
- The Phase 2a study results won’t be available until late 2024, delaying potential market entry.
- Current data is preclinical; efficacy in humans is yet to be proven.
- Existing treatments for IPF have set a high bar in terms of safety and efficacy.
Insights
GRI Bio's preclinical data showing the efficacy of GRI-0621 in reducing inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF) presents a promising development for a condition with limited treatment options. IPF, characterized by progressive lung scarring, currently only has two approved drugs with considerable side effects and no impact on survival. The data suggests that GRI-0621, a small molecule RAR-βγ dual agonist targeting iNKT cells, could potentially provide a more effective and tolerable treatment option.
The improvement in fibrosis and immunopathology in the animal model indicates that GRI-0621 effectively modulates disease pathways by inhibiting iNKT cell activity, which could be a game-changer in managing IPF. These findings support the rationale for advancing to a Phase 2a biomarker study, which will further evaluate its safety and efficacy in human subjects. Investors should pay attention to the upcoming data readouts, as positive results could significantly enhance the company's value and position in the market.
From a financial perspective, the progression of GRI Bio’s GRI-0621 into Phase 2a trials is a critical milestone. Successful interim and topline data readouts expected in Q3 and Q4 of 2024 could propel the company's stock, as these results would validate the preclinical efficacy and safety profiles in human subjects. Utilizing the 505(b)(2) regulatory pathway is a strategic move, potentially accelerating the approval process and reducing associated costs, which is beneficial for both the company and its investors.
Given that the current market for IPF treatments is underserved and dominated by only two drugs, GRI-0621 could capture significant market share if it proves to be effective and well-tolerated. This could lead to substantial revenue growth and market penetration. However, investors should remain cautious of the inherent risks associated with clinical trials and regulatory approvals. While promising, these advancements do not guarantee commercial success.
The IPF treatment market is relatively niche but presents substantial opportunities due to the severity and unmet medical needs associated with the disease. GRI Bio's GRI-0621 has the potential to disrupt the current market landscape by offering an alternative to existing treatments, which are often associated with severe side effects and limited efficacy. If the Phase 2a trials confirm the preclinical results, GRI-0621 could address a significant gap in the IPF market, leading to high patient uptake and better compliance.
Furthermore, targeting the iNKT cell pathway is a novel approach that could differentiate GRI-0621 from existing therapies, potentially making it a first-in-class treatment. The success of GRI-0621 could also pave the way for exploring similar mechanisms in other fibrotic and inflammatory diseases, expanding the market potential for GRI Bio’s pipeline.
Compared to controls, mice treated with GRI-0621 showed improved fibrosis and immunopathology; Inhibition of type 1 invariant Natural Killer T (iNKT) cell activity led to a decrease in fibrosis score and total lung inflammation
Company advancing Phase 2a biomarker study of GRI-0621 in patients with IPF with interim data expected Q3 2024 and topline data in Q4 2024
Data presented at the 2024 American Thoracic Society International Conference
LA JOLLA, CA, May 20, 2024 (GLOBE NEWSWIRE) -- 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 presented positive preclinical data demonstrating its lead program GRI-0621 reduces the important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF).
As part of the 2024 ATS International Conference held May 17-22, 2024 in San Diego, CA, Albert Agro, PhD, Chief Medical Officer of GRI Bio presented the poster titled “Altered NKT Cell Populations in the Airways of Patients With IPF,” which presented translational data from IPF patients as well as discussed data demonstrating that in a bleomycin-induced fibrosis model in mice, a selective inhibitor of iNKT cells, GRI-0621, can modulate the fibrotic condition and can reduce the important inflammatory and fibrotic drivers of the disease. Additionally, the design of the Phase 2a study examining the safety, tolerability, and effect on various biomarkers of GRI-0621 was presented.
“We believe this data further supports GRI-0621’s potential for the treatment of IPF,” commented Dr. Agro. “Our belief in the potential of our NKT platform technology continues to build, and we remain focused on leveraging its potential to develop novel biomarkers and therapeutic targets that differentiate stages of fibrosis progression. We are focused on the advancement of our Phase 2a biomarker study of GRI-0621 and look forward to the interim and topline data readouts in the coming quarters and discovering more about its potential to provide benefit to patients.”
Key Highlights Observed from GRI Preclinical & Translational Studies
- iNKT cells are found in increased number and activity in the BAL of patients with IPF as compared to age matched controls.
- iNKT cells are an early initiator of fibrotic disease effecting numerous pathways leading to fibrosis and inflammation.
- GRI-0621 is a small molecule RAR-βɣ inhibitor of iNKT cell activity facilitated by the binding to RAR receptors expressed to a higher level in iNKT cells compared to other T cell populations tested.
In an animal model of IPF, GRI-0621 was shown to reduce the fibrotic score, inhibit the production of TGFβ and VCAM-1 and reduce the immune cell.
IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on survival1.
GRI Bio’s lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits the activity of human iNKT cells. In preliminary trials to date and previous trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients.
The Company plans to leverage the 505(b)(2) regulatory pathway and has launched a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624.
About GRI Bio, Inc.
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 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. 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 IPF, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 NKT agonists for the treatment of systemic lupus erythematosus disease (SLE). Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the timing of initiation or completion of preclinical studies, clinical trials and availability of resulting data, the potential benefits and impact of the Company’s preclinical studies, clinical studies and product candidates and any implication that the data or results observed in preclinical trials or earlier studies or trials will be indicative of results of later studies or clinical trials, any implication that the Company’s product candidates will perform similarly to other candidates or approved therapies, the Company’s beliefs and expectations regarding future financial performance, and the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways,. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on Nasdaq and to comply with applicable listing requirements; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 28, 2024 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
GRI@jtcir.com
1 T. M. Maher et al., Global incidence and prevalence of idiopathic pulmonary fibrosis. Respir Res 22, 197 (2021)
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