4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of live biotherapeutics, announced positive top-line results for its Phase Ib study of Thetanix in paediatric patients with Crohn’s disease. The study achieved its primary objective, demonstrating that Thetanix was well tolerated with a good safety profile.
The randomised, double-blind, placebo-controlled study was conducted in two parts, with a single-dose phase and a multiple-dose phase and treated a total of 18 subjects aged 16-18 with Crohn’s disease. In the single-dose phase, eight subjects were given a single dose of either Thetanix or placebo. In the multiple-dose phase, 10 subjects were given either Thetanix or placebo twice daily for seven consecutive days.
The Company also announces the publication of data demonstrating the efficacy of Thetanix in pre-clinical models of inflammatory bowel disease (IBD). The data, published in the journal Inflammatory Bowel Diseases, showed that Thetanix demonstrated strong efficacy on the primary readouts in two different preclinical models with relevance to Crohn’s disease, protecting against weight loss, preventing histopathological changes in the colon and attenuating inflammatory mediators.
Using an in vitro co-culture assay, a pirin-like protein (PLP), produced by Thetanix, was also identified as a candidate effector molecule. Recombinant PLP was shown to be protective against colitis in a preclinical model and, like Thetanix, to act on NF-κB signalling in vitro.
Dr. Alex Stevenson, 4D’s Chief Scientific Officer, commented:
“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. 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.”
The journal article can be found here: https://academic.oup.com/ibdjournal/advance-article-abstract/doi/10.1093/ibd/izy281/5095645