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 provided a business outlook
and highlighted upcoming milestones for its innovative pipeline of
NKT cell modulators in development.
“We believe our leading NKT platform technology
represents a compelling opportunity with the potential for
significant value creation. Based on the data demonstrated to date,
we have confidence in our ability to modulate inflammatory diseases
earlier in the cascade to interrupt disease progression and provide
benefit to patients. We continue to make solid progress in the
advancement of our lead programs, GRI-0621 and GRI-0803, and are
poised to reach a number of value-driving milestones in the near
term,” commented Marc Hertz, PhD, Chief Executive Officer of GRI
Bio. “On the corporate front, we believe we have investment
proceeds and access to additional investment to fund planned
operations through 2024 and have bolstered the expertise of our
team and Board of Directors. We are well prepared to rapidly propel
the Company forward and are committed to providing much needed
treatment options for inflammatory, fibrotic and autoimmune
diseases.”
GRI-0621: Type
1 invariant NKT (“iNKT”) antagonist in development for the
treatment of idiopathic pulmonary fibrosis (IPF).
IPF is a rare chronic progressive pulmonary
disease with abnormal scarring of the lung blocking the movement of
oxygen into the bloodstream. GRI Bio’s lead program, GRI-0621 is a
small molecule RAR-βɣ dual agonist that inhibits the activity of
human Type I, iNKT cells. In preliminary trials to date1 and
previous trials with the oral formulation, GRI-0621 has been shown
to improve fibrosis in multiple disease models and improve LFTs and
other markers of inflammation and injury in patients.
Key Highlights:
- Orphan
indication with ~40,000 newly diagnosed cases in the United States
annually2
- Currently
available treatments for IPF are limited with only two approved
drugs that come with significant side-effects, limited compliance
and no impact on survival3
- Despite
challenges, total 2022 sales of the two approved drugs in the
United States were ~$4.3 billion combined4
- GRI-0621 is
designed to target upstream in the inflammatory cascade and to
provide potential for greater efficacy
- Established
safety profile as an oral formulation
- iNKT inhibition
demonstrated fibrosis resolution in multiple animal models
- Extensive IP
protection with issued medical use patents and market LOE through
2036
GRI is developing and repurposing GRI-0621 as a
once-daily oral capsule for the treatment of IPF with the potential
to expand into additional fibrotic indications. The Company plans
to leverage the 505(b)(2) regulatory pathway and to launch a Phase
2a biomarker study evaluating GRI-0621 for the treatment of IPF.
The 2:1 randomized Phase 2a study is expected to enroll
approximately 36 patients on background IPF therapy. At present,
the planned primary endpoint for the study is safety and
tolerability of oral GRI-0621 as assessed by clinical labs and
adverse events (AEs) after 12 weeks of treatment. Planned secondary
endpoints are change from baseline in serum biomarkers collected at
Week 6 and Week 12; assessment of the pharmacokinetics (PK) of
GRI-0621 at the Week 12 visit of treatment (steady state); and
determining the pharmacodynamic (PD) activity of oral GRI-0621 as
measured by inhibition of NKT1 cell activation in blood after 6
weeks and 12 weeks, and from bronchoalveolar lavage (BAL) fluid
after 12 weeks of treatment in a Sub-Study. An additional
exploratory endpoint for the study is to assess the effect of
GRI-0621 on pulmonary function at baseline and after 6 weeks and 12
weeks of treatment. The Company will conduct an interim analysis
when 8 of the 12 placebo-treated patients have completed 6 weeks of
treatment.
Expected Upcoming
Milestones
- H2 2023: Launch Phase 2a biomarker
study
- H1 2024: Report interim data from
Phase 2a biomarker study
- H2 2024: Report topline results
from Phase 2a biomarker study
GRI-0803: 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).
SLE, the most common form of lupus, is an
autoimmune disease in which the immune system attacks its own
tissue and organs. GRI Bio’s second asset in development, GRI-0803,
is a novel activator of human Type 2 NKT cells. 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.
Key Highlights:
- Annual prevalence estimated to be
~161,000 people in the United States affected with definite
SLE5
- Current treatments for SLE are
limited, consisting primarily of immunosuppressive therapies
- GRI-0803 is designed to target
upstream in the inflammatory cascade and to provide potential for
greater efficacy
- Oral administration in a
spontaneous model of lupus nephritis demonstrated significant
inhibition of pro-inflammatory cytokines, including IL-6 and IL-17;
significant inhibition of autoantibodies; and improvement in
overall and proteinuria-free survival
Expected Upcoming
Milestones
- Q1 2024: Complete IND-enabling studies
- H1 2024: File IND
- Q3 2024: Report Phase 1a SAD topline results
- Q4 2024: Report Phase 1b MAD topline results
Pipeline Expansion Opportunities
Additionally, with a library of over 500
proprietary compounds, GRI has the potential to fuel a growing
pipeline. The Company has ongoing evaluations for pipeline
expansion opportunities targeting potential indications in multiple
sclerosis, rheumatoid arthritis, inflammatory bowel disease,
insulin dependent diabetes mellitus and amyotrophic lateral
sclerosis.
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 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 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
initiation or completion of clinical trials, the potential benefits
and impact of the Company’s product candidates and the related
timing of regulatory approvals, if any, evaluations and judgements
regarding the Company’s intellectual property position, the ability
of the Company to achieve the milestones presented and the timing
of such milestones, any implication that the results or preliminary
results of earlier or prior clinical trials will be representative
or indicative of future clinical trials, estimates regarding the
funding necessary to fund the Company’s planned operations and any
estimate or implication as to potential market size or potential
revenue. 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; (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 their
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 its ability to serve those markets, either alone or in
partnership with others; (9) inaccuracy in the Company’s estimates
regarding expenses, future revenue, capital requirements and needs
for and the ability to obtain additional financing; (10) the
Company’s ability to protect and enforce its intellectual property
portfolio; and (10) 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 and Quarterly Report on Form 10-Q filed with the SEC on May 15,
2023 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. This press release also contains
estimates and other statistical data made by independent parties
and by the Company relating to market size and growth and other
data about its industry. This data involves a number of assumptions
and limitations, and you are cautioned not to give undue weight to
such estimates.
Investor Contact:JTC Team,
LLCJenene Thomas(833) 475-8247GRI@jtcir.com
1 I. Maricic et al., Differential
Activation of Hepatic Invariant NKT Cell Subsets Plays a Key Role
in Progression of Nonalcoholic Steatohepatitis. J
Immunol 201, 3017-3035 (2018), Tazoral™ for
the Treatment of Moderate to Very Severe Plaque Psoriasis Briefing
Document, Allergan
(https://wayback.archive-it.org/7993/20170405104812/https://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4062B1_01_Allergan-Background.pdf)
2 J. Sauleda, B. Núñez, E. Sala, J. B. Soriano, Idiopathic
Pulmonary Fibrosis: Epidemiology, Natural History,
Phenotypes. Med Sci (Basel) 6, (2018) 3
T. M. Maher et al., Global incidence and prevalence of
idiopathic pulmonary fibrosis. Respir
Res 22, 197 (2021)4 Companies’ earnings
reports5 https://www.cdc.gov/lupus/facts/detailed.html
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