Jaguar Animal Health Inc (NASDAQ:JAGX) has entered into an exclusive evaluation period starting April 3, 2017, with a major multinational animal health pharmaceutical company regarding Equilevia™, the lead product candidate for EGUS.
The details
Jaguar closed a dose determination trial of the target commercial paste preparation of Equilevia™ in Q4 2016. The equine veterinarians who conducted the trial were blinded to the treatment project, and Jaguar was blinded to the report at that time. A full assessment of the trial data with scoring of glandular and squamous ulcers has went through independent, blinded assessment by Dr. Frank Andrews, DVM, MS. The report from the dose determination trial will remain private during the 60-day assessment period.
The third-party assessment Dr. Andrews planned of the trial data involved looking at gastroscopy videos for participating horses and assessing each horse compared to 3 distinct EGUS grading measures – the McAllister scoring system which evaluates the severity and number of ulcers; the EGUS Council scoring system, which is applicable for squamous ulcers, and a latest visual analog scoring plan, relevant for both glandular and squamous ulcers, advanced by Dr. Andrews.
Dr. Andrews reported that this trial demonstrated consistency in the assessment of gastric ulcers by the newly advanced visual analog scoring setup against the published EGUS Council and McAllister grading scales. The visual analog scoring setup could be a vital tool in offering increased precision in gastric ulcers of opposing tissue type, like glandular lesions.
As Jaguar reported in January 2016, topline data from the firm’s proof-of-concept study to assess the effectiveness and safety of Equilevia™ suggest that 78 to 89% of horses cured with Equilevia™ had improvement or resolution of glandular ulcers for 14 days during treatment. The trial assessed a 10 grams of Equilevia™ dose administered orally four times daily and 5 grams of Equilevia™ administered twice daily.