Low pollen count disrupts Cobalis’ hayfever trial

In the randomized, six week, placebo-controlled trials involving a total of 1,551 subjects, PreHistin did not achieve statistically significant differences from placebo in the primary measure of efficacy, the reduction in total nasal symptom score (TNSS). However, the TNSS data for placebo-treated patients was far lower than would be expected for the moderate to moderately severe patient population called for in the protocol.

Low pollen counts in many of the regions during the time PreHistin was being tested may have resulted in low mean placebo symptom scores for the overall study population, the company said. The trials showed that PreHistin was well tolerated, contributing positively to the safety record of PreHistin’s active ingredient, cyanocobalamin.

A comparison of pre- and post-treatment blood levels of cobalamin demonstrated for the first time in a large study population that delivery of cyanocobalamin via sublingual lozenges resulted in significant increases in cobalamin blood levels.

Cobalis’ chief scientific officer, Ernest Armstrong, said: “Showing a meaningful reduction in allergy symptoms when the symptoms never increased throughout the pollen season to the desired moderate to moderately severe level is next to impossible. It’s like trying to prove that a pump can pump water out of a swimming pool when there is almost no water in the pool to begin with.

“Other pharmaceutical companies studying allergy drugs have reported problems with their clinical trials because of low symptom scores in an allergy season, with at least one report in an analogous situation occurring in the 2006 ragweed season when we conducted our trials.”