In a report published Wednesday, Morgan Stanley analysts maintained an Overweight rating on Gilead Sciences, Inc. GILD, after the company presented data from its phase 1 trial of GS-5745 in moderate-to-severe active ulcerative colitis.
The findings of the trials were:
- IV and SC dosing indicated both clinical and endoscopic efficacy when compared to placebo;
- RNA sequencing and immuno histology demonstrated likely biological activity of GS-5745; and
- The occurrence of AEs was in-line with that of placebo.
The clinical trials for Humira, Remicade, Simponi, and Entivyo all involved patients with similar characteristics to those seen in the GS-5745 trial, lending more relevance to cross trial comparison. The trials resulted in solid data versus competition.
"The pbo-adj clinical response rates, clinical remission rates, and endoscopic response rates for GS-5745 were higher than the pbo-adj rates for all of its competitors. However, given the small sample size of the GS-5745 these numbers should be interpreted with caution," the analysts mentioned.
The market for biologics in UC is estimated at about $2.5B and is growing in double digits. This market represents a huge opportunity for Gilead and starts to demonstrate that the company's pipeline "does present upside optionality." "If this early clinical profile plays out, GS-5745 could represent a ~$1B asset for Gilead which we currently do not model," the report added.
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