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NEW YORK, Mar 15 (Reuters Health) - Preliminary results show that an experimental drug can reduce the length and severity of the common cold, drug manufacturer ViroPharma said Thursday.
The success of two clinical trials follows the failure of the drug, Picovir, in two earlier studies reported on in April last year. Michel de Rosen, president and CEO of ViroPharma, said during a Thursday morning conference call that "we knew we had to reshape our clinical program to increase our likelihood of success. We accomplished that."
In the latest studies, a total of 2,096 patients were enrolled, 65% of which cold-like diseases caused by a picornavirus, which Picovir is specifically designed to target, versus 42% in the earlier studies.
Dr. Mark McKinlay, head of research and development at ViroPharma, said during the conference call that all patients in the study had a moderate to severe runny nose, and "one other respiratory symptom of cough, nasal congestion or sore throat."
All participants answered 'yes' to the question 'do you have a cold today,' but did not have a significant fever, allergy or chronic cough.
Experts contacted by Reuters Health said company's efforts to eliminate patients with conditions that could skew results, such as allergies, as a major contributor to the success.
In the two trials, patients were given tablets of either 400 milligrams of Picovir, also called pleconaril, or an inactive placebo three times daily for 5 days.
In analysis of both studies, ViroPharma reported, cold symptoms including runny nose resolved faster in pleconaril treated patients than in those given the placebo.
Patients treated with Picovir demonstrated a reduction in time to reporting having 'no cold.'
The treatment was well tolerated, and the side effect profile was similar to that of placebo.
Based on these data, ViroPharma expects to submit the drug for approval with the US Food and Drug Administration (FDA) by mid-year.
The company also plans to start evaluating the drug for treating the common cold in children and as a seasonal preventive in high-risk populations such as asthmatics.
While years off, some analysts see the potential for Picovir to become an over-the-counter medication.
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