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Cerenis to Present Clinical Proof-of-Concept Results for CER-627 Program

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Cerenis Therapeutics SA (Cerenis) has announced it will present the results of two clinical proof-of-concept studies for its CER-627 program (niacin/aspirin combinations) at the 78th European Atherosclerosis Society Congress on June 20-23 in Hamburg, Germany.

Niacin (NA) has proven cardiovascular benefit, including reduction in morbidity and mortality, however, its usage has been limited by facial flushing. This side effect often prevents patients from titrating to adequate dose levels and frequently results in discontinuation of dosing altogether.

Current niacin prescribing recommendations advise taking aspirin 30 minutes prior to niacin in order to inhibit COX1-dependent prostaglandin production in the skin, which is responsible for niacin-induced flushing.

However, because aspirin is rapidly metabolized and removed from the circulation, its effectiveness is limited. Better anti-flushing effects may be achieved by controlling and coordinating aspirin and niacin exposure such that aspirin is present at sufficient levels in the skin prior to, and during niacin exposure (Kuhrts et al. 1999. US patent 5,981,555).

Two Phase 1 proof-of-concept studies were conducted to evaluate simulated sustained-release aspirin regimens to decrease niacin-induced flushing. In the first study, 4 days of pre-dosing with 240 mg of aspirin, followed by a simulated sustained-release aspirin treatment regimen (20 mg/hr for 12 hrs), given in conjunction with 500 mg of immediate-release niacin at hour 6, was assessed in 30 subjects for its ability to inhibit niacin-induced flushing. The aspirin regimen resulted in a highly significant 53% reduction in the Maximal Severity of Flushing (MSF) (p=0.002) compared with Placebo.

In the second study, flushing induced by a single 2g dose of extended release-niacin (Niaspan®) was evaluated with two different sustained-release aspirin dosing regimens in 54 subjects. Regimen A consisted of 3 days of pre-dosing with 240 mg of aspirin, followed by aspirin 30 mg/kg for 8 hrs with extended-release niacin administered at hour 4. Regimen B consisted of no aspirin pre-dosing and aspirin 10 mg/hr for 6 hrs with extended-release niacin administered at hour 6. Regimen A significantly reduced the MSF by 37% compared with Placebo (p=0.0003) whereas regimen B had no significant effect (p=0.094). It was concluded that the timing and duration of aspirin exposure relative to niacin is important in inhibiting niacin-induced flushing.

These data support the development of a fixed-dose combination product of sustained-release aspirin and delayed and extended-release niacin. Such a product would be expected to increase patient compliance thereby allowing niacin to attain its full potential for cardiovascular protection.