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This compound has
been shown to be effective in reducing airway inflammation, improving
airways resistance and compliance and reducing hyper responsiveness in three
separate preclinical models of human asthma.
EPI-12323 administered once
daily has been studied in hundreds of patients having mild to severe
asthma and has shown an excellent safety profile in all clinical studies,
with no adverse effects observed on cortisol,
bone or androgenic metabolism. EPI-12323 has shown efficacy in an
allergen challenge study and clinical improvement in FEV1 over 4-weeks in
mild to moderate asthma.
In a recent Phase 2 clinical
study in 271 symptomatic moderate to severe asthmatics using a high
efficiency nebulizer device, EPI-12323 administered once daily showed
statistically and clinically meaningful improvement in a
validated asthma control questionnaire (ACQ) versus placebo at 6-weeks,
and in the average change in ACQ score. Further, significantly more
responders were in the EPI-12323 group than in the placebo group. Improvement trends were also noted
in rescue beta-agonist use and in the overall asthma symptom score. In this study, patients
were being treated with high dose ICS and long-acting beta-agonist
(LABA), and during a five-week run-in period, the patient’s high
dose ICS was reduced in two steps by 80% while continuing a constant LABA
dose. Patients were randomized
to either EPI-12323 or the vehicle control for 6-weeks, while continuing
on a low dose of ICS and LABA.
EPI-12323
showed statistically and clinically meaningful improvement in
patient’s ACQ score while on low dose ICS and LABA.
As a result of its ability to decrease both eosinophilic
and neutrophilic inflammation in the lungs, EPI-12323 is also being
developed for COPD. By specifically targeting the neutrophilic
inflammation, EPI-12323 is expected to reduce the ongoing tissue
destruction and improve small airway obstruction in COPD.
EPI-12323 administered once
daily has been studied in moderate to severe COPD and has shown an
excellent safety profile, with no adverse
effects observed on cortisol, bone or androgenic metabolism. EPI-12323 produced a clinical improvement
in FEV1 over 9-weeks in moderate to severe COPD patients.
Approximately 500 patients have now been safely dosed with EPI-12323.
Epigenesis has completed preclinical pharmacology studies
combining EPI-12323 with a long acting beta agonist as well as other drug
classes, and has filed patent applications for these combinations.
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