HONG
KONG, GERMANTOWN, Md.
and SUZHOU, China,
July 12,
2024 /PRNewswire/ -- Sirnaomics Ltd. (the
"Company", Stock Code: 2257.HK, together with its
subsidiaries, the "Group" or "Sirnaomics"), a
leading biopharmaceutical company engaging in discovery and
development of advanced RNAi therapeutics, announced today that
the Group has completed IND-enabling studies for STP125G, an
siRNA therapeutics targeting Apolipoprotein C3 (ApoC3), based
on its proprietary GalAhead™ mxRNA technology. The safety and
efficacy results from the non-human primate (NHP) studies strongly
support for an IND filing with the U.S. FDA for initiating a Phase
I clinical study of STP125G for cardiovascular disease
indications.
ApoC3 is a widely known player in triglyceride metabolism, and
it has been recently recognized as a polyhedric factor which
may regulate several pathways beyond lipid metabolism by
influencing cardiovascular, metabolic, and neurological disease
risk. High levels of triglycerides (TG) have been shown to be
associated with increased risk of cardiovascular diseases. For
severe hypertriglyceridemia (sHTG) patients whose TG level is more
than 1000 mg/dL, the risk of developing acute pancreatitis is 5 to
10 times to that in the general population. Down-regulation of
ApoC3 using siRNA or antisense oligonucleotides has been shown to
be effective in lowering TG in sHTG patients.
During an efficacy evaluation of STP125G with non-human primate
model (N = 4), we observed a dose-dependent silencing activity
among 1 mg/kg, 3 mg/kg and 10 mg/kg doses with a strong safety
profile. The maximum target silencing efficacy was achieved at 10
mg/kg dosage around week 4 and was maintained for an additional 9
weeks (the total length of this 13-week study). The safety
evaluation of STP125G using non-human primate model (N = 4)
demonstrated an excellent safety readout with a single subcutaneous
administration at 50 mg/kg, 100 mg/kg or 250 mg/kg. The
maximum target silencing efficacies were like the level of 10
mg/kg for all three high dosages.
"STP125G is the second drug candidate based on our GalAhead™
mxRNA technology that has shown excellent safety and potent
efficacy results with the NHP models. Its long-lasting silencing
activity against ApoC3 may provide better therapeutic benefit to
patients suffering cardiovascular conditions, than those of
antisense and other siRNA drugs." Dr. Patrick Lu, Founder, Chairman of the
Board, Executive Director, President and Chief Executive
Officer of Sirnaomics, indicated. "Those data
readouts further validated STP125G as a novel siRNA
therapeutic candidate for treatment of hypertriglyceridemia and
other cardiovascular diseases, using our proprietary
GalAhead™-based delivery technology".
- End -
About ApoC3 and STP125G
ApoC3 is an important emerging target linking
hypertriglyceridemia with cardiovascular disease (CVD). ApoC3 is a
potent modulator of many established CVD risk factors, and is found
on chylomicrons, VLDL, LDL, and HDL particles. Many studies show
that in humans, apoC3 levels are an independent risk factor for
CVD, and its presence on lipoproteins may promote their
atherogenicity. Recent findings of the role of ApoC3 has been
implicated in HDL metabolism and in the development of
atherosclerosis, inflammation, and ER stress in endothelial cells.
ApoC3 has been recently considered an important player in insulin
resistance mechanisms, lipodystrophy, diabetic dyslipidemia, and
postprandial hypertriglyceridemia (PPT). The emerging evidence of
the involvement of ApoC3 in the pathogenesis of Alzheimer's disease
open the way to further study if modification of ApoC3 level slows
disease progression. Furthermore, ApoC3 is clearly linked to
cardiovascular disease (CVD) risk, and progression of coronary
artery disease (CAD) as well as the calcification of aortic valve
and recent clinical trials has pointed out the inhibition of ApoC3
as a promising approach to manage hypertriglyceridemia and prevent
CVD. Several evidences highlight the role of ApoC3 not only in
triglyceride metabolism but also in several cardio-metabolic
pathways. STP125G is a single-stranded siRNA therapeutics targeting
ApoC3 mRNA, based on Sirnaomics proprietary GalAhead™ mxRNA
technology.
About Sirnaomics
Sirnaomics is an RNA therapeutics biopharmaceutical company that
focuses on the discovery and development of innovative drugs for
indications with unmet medical needs and large market
opportunities. Sirnaomics is the first clinical-stage RNA
therapeutics company to have a strong presence in both Asia and the United
States. Based on its proprietary delivery technologies, a
polypeptide nanoparticle RNAi platform and GalNAc RNAi platform,
GalAhead™, Sirnaomics has established an enriched drug candidate
pipeline. STP122G, which represents the first drug candidate
utilizing the Group's GalAhead™ mxRNA technology, is currently in
Phase I development. STP125G is the second siRNA therapeutics based
on Sirnaomics proprietary GalAhead™ mxRNA technology,
targeting ApoC3 mRNA for cardiovascular disease treatment. STP237G
is the first dual-targeted drug based on a GalAhead™ muRNA
technology and is in the late stage of preclinical evaluation. The
Group has also had multiple successes with oncology applications
through its clinical programs for STP705 and STP707. With the
expansion of the Group's clinical pipeline and establishment of the
Group's manufacturing facility, Sirnaomics focuses on a transition
from a biotech company to a biopharma corporation. Learn more at:
www.sirnaomics.com.
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