Increasing Percentages of New Drugs are Failing Phase II and III Trials

In the drug discovery pipeline, Phase I trials are first used to evaluate if a new drug is safe, then Phase II trials are done to assess the drug’s efficacy, and finally Phase III trials are performed to monitor side effects and compare the drug to similar compounds already on the market. Each consecutive phase includes more people to refine the results obtained in the previous phase. A recent analysis by the Centre for Medicines Research in the UK has concluded that since 2008, the failure rate for drugs in Phase II and III clinical trials has been rising [1-2]. Phase II success rates are currently at 18%, lower than at any other phase of drug development.

Drug development pipeline

Synergy Between Antibiotics and Nonantibiotic Drugs

Antibiotic resistance is an ever-growing clinical problem. Four years ago, a study found that antibiotics are overprescribed for sinus infections. Compounding the issue is the fact that as bacteria are learning to tolerate and even circumvent existing classes of antibiotics, not enough work is being done to discover new ones. Combinations or cocktails of antibiotics are often used to broaden the antimicrobial spectrum of each and to achieve synergistic effects; this approach has successfully been applied to combat tuberculosis, leprosy, malaria, and famously, HIV. Yet the discovery of effective combinations has usually been almost fortuitous, most often resulting from trial and error rather than a systematic analysis.

Antibiotic cocktail

In the current study, researchers systematically examined combinations of 1,057 compounds previously approved as drugs to find those that exhibited synergy with the antibiotic minocycline. Their work is reported in the April 24, 2011 issue of the journal Nature Chemical Biology [1]. The compounds were chosen because they have already been approved as drugs, they are known to have activity in vivo and are known to be relatively safe. Many approved drugs are known to have utility for clinical indications other than those for which they initially received approval. Moreover, using pre-approved compounds also reduces the time and cost associated with developing new compounds for therapeutic use.

Sun Exposure, Vitamin D Can Affect Breakdown of Medicines

Genetic variation has been though to be responsible for the differences between people to metabolize certain drugs. The results of a recent study from the Karolinska Institutet in Sweden suggest that it may be even more complicated. Swedish reserchers have found that the body’s ability to break down medicines may be closely related to sunlight exposure and vitamin D, and thus may vary with the seasons. The study, published in the journal Drug Metabolism & Disposition, offers a completely new model to explain individual differences in the effects of drugs [1].

Sunlight can influence the breakdown of medicines in the body

Genetic Risk Factor for Peanut Allergies Identified

It is difficult to find a school, camp or other facility catering to children these days that is not nut free. The prevalence of peanut allergies in preschool and school age children in the UK, the US and Canada is between 1.2 – 1.6%, which is about twice the rate at which it occurs in adults in these countries. Nut allergies, especially peanut allergies, are scary. And although they have been on the rise, no one really knows why. Researchers in Scotland recently reported in The Journal of Allergy and Clinical Immunology that mutations in the gene for filaggrin, a protein found in skin, are a “significant risk factor for peanut allergy” [1].

Peanuts and peanut butter

Scientists Learn Why a Little Alcohol Can Be Good For You

A number of studies have asserted that moderate drinking has a positive benefit on cardiovascular health. Now, scientists at the University of Rochester Medical Center have discovered how alcohol consumption can help to prevent heart disease. The research, published in the journal Arteriosclerosis, Thrombosis and Vascular Biology, studied the effects of moderate amounts of alcohol in human coronary artery smooth muscle cells and in the carotid arteries of mice [1]. In both cases, regular, limited amounts of alcohol inhibited a protein called Notch 1 and prevented the buildup of smooth muscle cells in blood vessels that leads to the narrowing of the arteries and can put you at risk for a heart attack or stroke.

Red wine