BELLUS Health has received positive regulatory feedback from the FDA in relation to this clinical Phase 2 study protocol for the assessment of the efficacy and safety of Shigamab™ in the treatment of children suffering from sHUS. BELLUS Health is currently planning the next steps for the initiation of this clinical Phase 2 study.
BELLUS Health has completed an additional pre-clinical study in a sHUS baboon model, which recapitulates a pathophysiology similar to that in sHUS patients. The objective of this study was to assess the effect of Shigamab™ on the progression of sHUS. In this study, Shigamab™ was shown to rescue the animals against a lethal dose of toxin when administered up to 48 hours post-intoxication. Shigamab™ was also found to inhibit the kidney injury caused by Shiga toxin 2 and protect the animals against the extra-renal complications associated with the Shiga toxin 2 intoxication. These results are consistent with the protective effects of Shigamab™ previously seen in the mice that received lethal doses of Shiga toxin E. coli or lethal dose of Shiga toxin 2.
In September 2015, the Company presented data from clinical and pre-clinical studies evaluating Shigamab™ in the treatment of sHUS at the International Symposium on Shiga toxin (verocytotoxin) Producing Escherichia Coli (VTEC) 2015 Conference in Boston. During the conference, BELLUS Health held its first Shigamab™ Scientific Advisory Board (SAB) meeting.
During 2014, in studies performed in collaboration with the Uniformed Services University of the United States Department of Defense, Shigamab™ was shown to reduce toxicity of Shiga toxin type 2 in a sHUS mouse model, even following a two to four-day delayed treatment, as measured by body weight loss, renal biomarkers and renal histopathology. These results support BELLUS Health's treatment approach of sHUS.
Shigamab™ previously completed a Phase 2 clinical trial where it was shown to be safe and well tolerated in a STEC-positive pediatric population. Following the acquisition of Shigamab™ through the acquisition of Thallion Pharmaceuticals Inc. in 2013, the Company shifted the program’s focus from prevention to treatment of sHUS. Current pre-clinical efforts are geared towards the validation of the new development approach prior to undertaking further clinical trials.