GRI Bio Announces European Patent Office Issued a Decision to Grant Notice for Patent Covering GRI-0803 and Its Library of 500+ Proprietary Compounds
December 23 2024 - 9:00AM
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 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.
“We have continued to make encouraging progress
in our initiative to bolster our global patent estate covering our
innovative pipeline of NKT cell modulators and library of over 500
proprietary compounds. We are pleased to add this anticipated
European patent to our intellectual property portfolio. We continue
to believe in our highly differentiated approach to the prevention
and treatment of inflammatory, fibrotic and autoimmune diseases and
look forward to further advancing their development to ultimately
address areas of significant unmet medical need,” Marc Hertz, PhD,
Chief Executive Officer of GRI Bio.
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). Activation of
type 2 NKT leads to a dendritic cell-mediated inhibition of iNKT
cells. In the Company’s preclinical studies, type 2 NKT activating
molecules, GRI-0803 and GRI-0124, were observed to inhibit both
murine and human iNKT cells. Oral administration of these type 2
NKT activating molecules was observed to inhibit lupus nephritis
and to significantly improve overall survival. 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.
The Company is currently advancing the
development of its lead program, GRI-0621, in a Phase 2a,
randomized, double-blind, multi-center, placebo-controlled,
parallel-design, 2-arm study for the treatment of IPF. Interim data
from the Phase 2a biomarker study is expected in the first quarter
of 2025 and topline results are expected in the second quarter of
2025. 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. Type 1 invariant (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 NKT 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.
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 clinical trials and availability of
resulting data, the potential benefits and impact of the Company’s
clinical trials 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, the Company’s beliefs and expectations regarding
potential shareholder value and future financial performance, the
Company’s beliefs about the timing and outcome of regulatory
approvals and potential regulatory approval pathways, the Company’s
expected milestones for the first half of 2025, and the Company’s
beliefs and expectations regarding the sufficiency of its existing
cash and cash equivalents to fund its planned operations, its
ability to raise additional funds, which may not be available to
the Company on acceptable terms or at all, and capital expenditure
requirements. 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, LLCJenene
Thomas(908) 824-0775GRI@jtcir.com
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