TA 8995 success in Phase IIb TULIP study for dyslipidaemia- Dezima Pharma

Dezima Pharma, the biotechnology company developing innovative drugs in the field of dyslipidemia, announced the publication of the phase IIb TULIP study results with its CETP inhibitor, TA-8995, in the Lancet. The TULIP (�TA-8995: its Use in patients with mild dysLIPidaemia�) study was conducted in specialized cardiovascular centres across Denmark and the Netherlands. A total of 364 individuals with dyslipidaemia were randomised into nine cohorts: placebo, TA-8995 as monotherapy at different doses, or in combination with different statins. The study investigated the effects of TA-8995 on a wide range of established cardiovascular disease (CVD) biomarkers over a three month dosing period.

The results showed potent effects on the primary endpoint, which was a composite of change from baseline in LDL-C and HDL-C. 5 mg of TA-8995 reduced LDL-C by 45% and increased HDL-C by 161%. 10 mg of TA-8995 in combination with statin therapy reduced LDL-C by an additional 48%. With this combination therapy nearly all patients achieved the most stringent LDL-C target of <1.8 mmol l. in addition ta-8995 boosted cholesterol efflux significantly. finally ta-8995 was safe and well tolerated without any drug accumulation as has been reported with other cetp inhibitors. this study clearly shows that ta-8995 is a best-in-class cetp inhibitor with an unrivalled combined efficacy and safety profile added dezimas ceo rob de ree. besides requiring frequent injections pcsk9 antibodies will likely be expensive and have not shown any beneficial effect on cholesterol efflux.>

See- �Cholesterol ester transfer protein inhibition by TA-8995 in patients with mild dyslipidaemia (TULIP): a randomised, double-blind, placebo-controlled phase 2 trial�. - Philip Barter et al. The Lancet 2 June 2015 DOI: http://dx.doi.org/10.1016/S0140-6736(15)60158-1

Comment:The high levels of efficacy demonstrated by TA 8995 (DEZ 001) suggests it has potential as a more cost-effective option for lowering cholesterol than the PCSK9 inhibitor approach.