Essentialis Meets Primary Endpoint in Phase 2b Trial of DCCR for Treatment of
Hypertriglyceridemia and is Granted Extensive Patent Coverage in the US
CARLSBAD, Calif., May 17 /PRNewswire/ -- Essentialis Inc, a clinical stage
pharmaceutical company, announced today that it met its primary endpoint of
statistically significant triglyceride reduction in a 90-patient Phase 2b
trial of DCCR in dyslipidemic patients. The study encompassed both patients
with very high triglycerides and mixed dyslipidemia and included normal
weight, overweight and obese patients presenting with or without hypertension.
The randomized, double-blind study, which was powered as if it were pivotal,
assessed the drug's effect on dyslipidemia and evaluated three different doses
of DCCR given over an 8-week period compared to placebo. The study included 90
subjects with high and very high triglycerides as well as subjects on stable
doses of statins. At the end of 8 weeks, treatment with DCCR resulted in a 30%
placebo-adjusted median reduction in triglycerides. The reduction was
clinically relevant, highly significant and competitive with existing approved
drugs. In subjects with very high baseline triglycerides, DCCR treatment
resulted in a substantially greater reduction in triglycerides. In contrast
to the effects of Lovaza and fenofibrate - the current gold standard medicines
for treating hypertriglyceridemia - no meaningful increase in LDL-C was
observed in DCCR-treated subjects, irrespective of baseline triglyceride
levels. In subjects with elevated LDL-C at baseline, DCCR treated subjects
experienced a fall in LDL-C. Reductions in non-HDL-C and total-C were also
observed in DCCR treated subjects together with a modest rise in HDL-C. In
subjects on steady doses of statins, the effects of DCCR appeared to be
additive to statin therapy. Weight and waist circumference reduction, blood
pressure lowering, LFT and insulin resistance improvements were also
demonstrated. DCCR was generally well tolerated, and most of the AEs were mild
to moderate, resolving without sequelae. There were no SAEs and the
discontinuation rate due to AEs was in line with historic lipid-lowering
trials.
Separately, the company further announced the allowance of a US patent
covering DCCR. The patent entitled "Salts of potassium ATP channel openers and
uses thereof" contains claims to salts of diazoxide - including DCCR - as well
as pharmaceutical formulations of such salts. Additional applications filed in
the US and globally will further enhance the patent portfolio of Essentialis.
Commenting on these developments, Essentialis President and CEO, Dr Iain Dukes
said, "Essentialis has convincingly demonstrated the therapeutic utility of
DCCR as a triglyceride lowering agent with a superior profile to existing
approved drugs. The issuance of the patent covering DCCR provides timely
coverage for its future commercial development."
Pivotal phase 3 protocols for very high triglycerides and phase 2 protocols
for statin combination therapy are currently being finalized with input from
experts and the FDA in parallel with partnering discussions.
About DCCR
DCCR, diazoxide choline controlled release, is an ATP-dependent potassium
channel agonist with potential utility in several cardiovascular and metabolic
diseases. Extensive Phase 1 testing and investigator-sponsored clinical
studies have demonstrated the drug's potential to lower triglycerides, non-HDL
cholesterol and LDL-cholesterol while raising HDL-cholesterol. In addition,
placebo adjusted weight loss exceeding 5% in an 8-week placebo controlled
study and 10% in a 6-month study has been demonstrated. Compositions of
matter, formulation and method of use patents for DCCR have been filed
worldwide. A fixed dose combination product with a statin is under
development.
About Very High Triglycerides
Hypertriglyceridemia, a disease where patients have high blood levels of
triglycerides, is associated with increased risk of coronary heart disease
even after LDL-cholesterol targets have been achieved. Very high triglycerides
are associated with an increased risk of developing pancreatitis. There are
approximately 5 million patients in the US with very high triglycerides. The
leading products for treating very high triglycerides, Lovaza and fenofibrate,
while effective, also cause significant elevations in LDL-cholesterol.
About Essentialis
Essentialis is a pharmaceutical company based in Carlsbad, CA focused on the
development of breakthrough medicines for the treatment of cardiovascular and
metabolic diseases. The company's portfolio of products is targeted at the
ATP-sensitive potassium channel, a metabolically-regulated membrane protein
whose modulation has the potential to impact a wide range of cardiovascular
and metabolic diseases. The company's lead product has completed Phase 2
studies in dyslipidemic subjects. The company is actively exploring partnering
arrangements for DCCR and its portfolio of follow-on and back-up compounds.
SOURCE Essentialis
Iain D Dukes MA DPhil, President and Chief Executive Officer,
idukes@essentialistherapeutics.com, or Neil M. Cowen MBA PhD, Chief Scientific
Officer, nmcowen@essentialistherapeutics.com, both of Essentialis,
+1-760-431-2646
