The randomized, double blind, placebo-controlled studies are intended to assess the efficacy and safety of pre-seasonal treatment with PreHistin on moderate to moderately severe seasonal ragweed allergy patients.
The 10-week clinical trials are being conducted at 23 sites across the central, southern, and eastern US and will utilize electronic diary records to assess improvement in total nasal symptom score (TNSS).
Approximately 1,600 to 2,000 patients in total will be randomized into the twin studies to receive either placebo or 3.3mg sublingual PreHistin twice daily for three weeks prior to the onset of the ragweed allergy season, and for an additional three weeks into the allergy season.
As in the company’s previous phase III trial, the studies’ primary end point will be improvement in TNSS in weeks four, five and six. To determine the lasting effect, a secondary endpoint will measure the symptomology for patients over the last four weeks of the study. These twin studies are anticipated to fulfill the requirement for the two phase III double blind, placebo controlled studies typically required for FDA approval.
“The results of our previous phase III clinical trial of PreHistin in patients with Mountain Cedar seasonal allergies were encouraging, and we are eager to prove the potential of PreHistin as a treatment for nasal allergy symptoms in these seasonal ragweed studies,” said Cobalis CEO, Dr Gerald Yakatan.