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news.Arisaph has received the US Food and Drug Administration's (FDA) acceptance for its Investigational New Drug (IND) application to initiate ARI-3037MO Phase I human clinical trial in healthy volunteers for the treatment of dyslipidemia.
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ARI-3037MO is a structural analog of niacin to treat mixed lipid disorders and hypercholesterolemia in 93 million Americans.
Successful completion of preclinical pharmacology and toxicology studies by Arisaph showed favourable safety profile and produced greater lipid responses than niacin and reduced tingling or redness of the skin.
In preclinical studies that compared the compound with the niacin producing the irritating side effect of flushing , higher doses of ARI-3037MO showed changes in low density lipids (LDL) and high density lipids (HDL) and triglycerides (TGs) by reducing LDL, TGs and increasing mRNA levels proteins involved in HDL synthesis .
Arisaph Pharmaceuticals president and CEO Christopher Kiritsy said the company developed the compound from lead selection to IND filing in about 9 months and designed a once a day, analog of niacin that has niacin’s biological merits, without causing the side effects of flushing.
The first-in-man clinical trials are expected to begin this month.