24th Sep 2018 08:45
LONDON (Alliance News) - 4d Pharma PLC on Monday said its phase Ib study of Thetanix in paediatric patients with Crohn's disease achieved its primary objective.
Crohn's disease is a chronic inflammatory bowel disease which can occur in any part of the gastro-intestinal tract.
The pharmaceutical company said the trial demonstrated that Thetanix capsules were well tolerated with a good safety profile.
The study was conducted in two parts, including a single-dose phase and a multiple-dose phase. The total number of participants was 18, aged between 16 and 18 years old.
In the single-dose phase, eight patients were given a single dose of either Thetanix or placebo, while in the multiple-dose phase, 10 patients were given either Thetanix or placebo twice daily for seven consecutive days.
"These promising results add to the growing body of evidence on the efficacy of Thetanix, further reinforcing its potential as a novel treatment for Crohn's disease," said Chief Scientific Officer Alex Stevenson.
"Achieving the primary objective of the Phase Ib study, demonstrating the safety and tolerability of Thetanix, is an important milestone in the development of this programme," added Stevenson.
Shares in 4d Pharma were trading 1.8% higher on Monday morning at 180.50 pence each.
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