Medical Therapies Limited today announced that it has completed its ‘first in human’ clinical trial of Cuprindo™ with interim results from patient diaries indicating that Cuprindo™ is safe and well tolerated.
The trial subjects, healthy volunteers, reported 100% compliance with the dosing protocol which involved application of Cuprindo™ suppositories twice daily over a seven day period. In addition, post-trial colonoscopy on the subjects uncovered healthy mucosa and no evidence of rectal inflammation or ulceration.
The safety trial was conducted in preparation for a planned efficacy study in proctitis patients.
“The trial has been a success confirming our pre-clinical safety information on Cuprindo™ and it paves the way for our efficacy study in patients with proctitis,” said Medical Therapies Chief Executive Officer Maria Halasz.
While the trial was not geared to assess Cuprindo™’s systemic efficacy, one subject reported relief in chronic joint pain after Day 4 of the trial. Results of the full biochemical analysis of the trial assays including information on systemic absorption characteristics of Cuprindo™ are expected in the coming weeks.
Proctitis is a debilitating disease characterised by inflammation and ulceration of the colon, resulting in tiny open sores that can bleed and produce mucus. Symptoms of the disease include chronic diarrhoea, bloody stools and, in severe cases, faecal incontinence.
Current treatments such as corticosteroids and immuno-modulators can cause serious side effects and provide no relief for up to 30% of proctitis patients. A topically applied safe treatment, such as a Cuprindo™ suppository, could provide a much needed alternative for the 1 in 60 people suffering from the disease.