Gemcabene met the primary endpoint and
demonstrated a statistically significant lowering in LDL-C
Gemphire Therapeutics Inc. (NASDAQ:GEMP) today announced top-line
data based upon the Company’s preliminary review of the limited
top-line data set from the completed double-blind,
placebo-controlled, randomized Phase 2b ROYAL-1 trial.
ROYAL-1 evaluated the efficacy, safety, and tolerability of oral
gemcabene 600 mg dosed once daily.
ROYAL-1 enrolled patients who were not adequately controlled,
with an existing LDL-C value ≥100 mg/dL (2.59 mmol/L) and a TG
value < 500 mg/dL (5.65 mmol/L), on stable high- or
moderate-intensity statin and/or ezetimibe therapy. Patients were
stratified according to background statin intensity and diabetes
status. One hundred and five subjects were enrolled at sites in the
US and randomized to either gemcabene 600 mg or placebo for a total
of 12 weeks. The primary endpoint was the percent change in
LDL-C from baseline. Secondary endpoints included safety as
well as the percent change from baseline in non-HDL-C, TC, TG,
HDL-C, VLDL-C, Apo B, hsCRP and several other biomarkers.
Fifty-six (56) females and 49 males with a mean age of 61 years
were enrolled. The mean baseline LDL-C was 130 mg/dL.
Gemcabene 600 mg produced a mean percent change in LDL-C of
-17.2% vs -5.5% for placebo (ANCOVA: p=0.0057). Gemcabene 600
mg produced a median percent change in hsCRP of -40.0% (ranked
ANCOVA: p<0.0001) vs -6.1% for placebo. Additional
secondary results and subpopulations assessments will be provided
once the full dataset has been analyzed.
“In ROYAL-1, gemcabene met the primary endpoint and demonstrated
a statistically significant lowering in LDL-C, although the
magnitude of LDL-C lowering was less than observed in certain prior
studies of gemcabene,” stated Dr. Lee Golden, Chief Medical
Officer. “The company will perform additional analyses to
thoroughly evaluate the results of the trial. Once the
additional analyses are complete, we will provide an update.”
There were no serious adverse events in the study. Adverse
events (AEs) were generally mild to moderate in intensity and
consistent with previously reported AEs. Three subjects
discontinued from the study, 1 from the gemcabene and 2 from the
placebo groups. The subject randomized to gemcabene
discontinued because of reported dizziness. No subjects in
the study had a transaminase elevation > 3x ULN. One
placebo subject had a creatine kinase elevation > 5x ULN on
consecutive measurements. No gemcabene subjects had
consecutive elevations in creatine kinase > 3 x ULN. The lack of
liver or muscle toxicities in ROYAL-1, on top of the highest doses
of statin therapy, is consistent with previous safety data from 19
prior completed studies.
“The ROYAL-1 study results support gemcabene’s safety profile as
a potential add-on therapy to any statin intensity without signs of
drug-drug interactions,” added Dr. Steven Gullans, Interim
CEO. “The data, in combination with previous clinical data of
gemcabene, including the recently reported results of the COBALT-1
trial, will be used to plan gemcabene’s future development.”
Additional information on the ROYAL-1 trial, including
eligibility criteria and site locations, can be found at
www.clinicaltrials.gov using the NCT Identifier
NCT02634151.
Conference Call and Webcast Gemphire will
further review the top-line data from the ROYAL-1 Phase 2b clinical
trial in hypercholesterolemic patients in a conference call today
at 8:00 am ET. To participate, please dial (844) 494-0188
(domestic) or (425) 278-9114 (international) and reference
conference ID 67117890. A webcast replay will be available on the
News & Events section of the Gemphire website for all
interested parties following the call and will be archived and
available for 90 days.
About GemcabeneGemphire’s product candidate,
gemcabene (CI-1027), is a first-in-class, once-daily, oral therapy
that may be suitable for patients who are unable to achieve normal
levels of LDL-C or triglycerides with currently approved therapies,
primarily statins. Gemcabene's mechanism of action enhances
the clearance of very low-density lipoproteins (VLDLs) in the
plasma and inhibition of the production of cholesterol and
triglycerides in the liver. The combined effect for these
mechanisms has been clinically observed to result in a reduction of
plasma VLDL-C, LDL-C, and triglycerides. In addition,
gemcabene has been shown to markedly lower C-reactive protein and
improve insulin sensitization. Gemcabene is liver-directed
and reduces apoC-III mRNA and plasma levels. Gemcabene also
reduces acetyl-CoA carboxylase (ACC1) and CCR2/CCR5 receptor mRNA
levels, which may have applications in non-alcoholic
steatohepatitis (NASH)/non-alcoholic fatty liver disease
(NAFLD). Gemcabene has demonstrated proof of concept efficacy
for NASH in the STAM™ model developed at SMC Laboratories in Tokyo,
Japan. Gemcabene has been tested as monotherapy and in combination
with statins and other drugs in 956 subjects across 20 Phase 1 and
Phase 2 clinical trials and has demonstrated promising evidence of
efficacy, safety and tolerability.
About GemphireGemphire is a clinical-stage
biopharmaceutical company that is committed to helping patients
with cardiometabolic disorders, including dyslipidemia and
NASH. The Company is focused on providing new treatment
options for cardiometabolic diseases through its complementary,
convenient, cost-effective product candidate gemcabene as add-on to
the standard of care especially statins that will benefit patients,
physicians, and payors. Gemphire has initiated 3 clinical
trials for homozygous familial hypercholesterolemia (HoFH),
heterozygous familial hypercholesterolemia (HeFH)/atherosclerotic
cardiovascular disease (ASCVD), and severe hypertriglyceridemia
(SHTG) under NCT02722408, NCT02634151, and NCT02944383,
respectively with a fourth planned trial in NASH. Please
visit www.gemphire.com for more information.
Forward Looking Statements Any statements in
this press release about Gemphire’s future expectations, plans and
prospects, including statements about Gemphire’s financial
prospects, future operations and sufficiency of funds for future
operations, clinical development of Gemphire’s product candidate,
expectations regarding future clinical trials and future
expectations and plans and prospects for Gemphire, expectations
regarding operating expenses and cash used in operations, and other
statements containing the words "believes," "anticipates,"
"estimates," "expects," "intends," "plans," "predicts," "projects,"
"targets," "may," "potential," "will," "would," "could," "should,"
"continue," “scheduled” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
success and timing of Gemphire’s regulatory submissions and
pre-clinical and clinical trials; regulatory requirements or
developments; changes to Gemphire’s clinical trial designs and
regulatory pathways; changes in Gemphire’s capital resource
requirements; Gemphire’s ability to obtain additional financing;
Gemphire’s ability to successfully market and distribute its
product candidate, if approved; Gemphire’s ability to obtain and
maintain its intellectual property protection; and other factors
discussed in the "Risk Factors" section of Gemphire’s Annual Report
on Form 10-K for the year ended December 31, 2016 and in other
filings Gemphire makes with the SEC from time to time. In
addition, the forward-looking statements included in this press
release represent Gemphire’s views as of the date hereof.
Gemphire anticipates that subsequent events and developments will
cause Gemphire’s views to change. However, while Gemphire may
elect to update these forward-looking statements at some point in
the future, Gemphire specifically disclaims any obligation to do
so. These forward-looking statements should not be relied
upon as representing Gemphire’s views as of any date subsequent to
the date hereof.
Contact:
Andrew McDonald, Ph.D.
LifeSci Advisors, LLC
(646) 597-6987
Jeff Mathiesen, CFO
Gemphire Therapeutics Inc.
(734) 245-1700
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