Small molecule IBD treatment begins phase 1 trial
A phase 1 clinical trial to test the safety and tolerability of BT-11, an investigational small molecule for the treatment of inflammatory bowel disease, is currently under way.
According to the manufacturer, Landos Biopharma, BT-11 has shown safety and efficacy in multiple preclinical trials. Landos hopes the drug will serve as an alternative to current therapies without many of the same side effects, according to a press release.
“Current treatment options for IBD have a number of drawbacks as they only benefit a limited number of patients, lose response effectiveness, or cause unwanted side effects,” Jean-Frederic Colombel, MD, a Landos Clinical Advisory Board member and director of the IBD Center at the Icahn School of Medicine at Mount Sinai, said in the press release. “An orally active therapeutic with local action in the GI tract and low systemic exposure such as BT-11 may represent a unique and promising approach to treating patients with safer, more convenient, and effective therapeutic alternatives to biologics, steroids, or surgeries.”
The drug targets the gastrointestinal tract through the Lanthionine Synthetase C-Like 2 (LANCL2) pathway and helps create a favorable regulatory microenvironment in the gut. This limits the production of inflammatory mediators and promotes anti-inflammatory molecules, according to the press release.
The randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1 trial will ultimately include 70 healthy volunteers and is intended to investigate the safety and tolerability of BT-11.
“Launching this trial marks a significant milestone for Landos and represents the next step in confirming the safety and effectiveness of BT-11, which has the potential to greatly impact the treatment options of millions of people afflicted by IBD around the world,” Josep Bassaganya-Riera, DVM, PhD, chairman and CEO of Landos, said in the press release. “Despite current treatments, there remains an unmet clinical need for chronic therapies for UC and CD with improved safety and tolerability.”
Disclosures: Bassaganya-Riera is employed by Landos Biopharma. Colombel serves on the Landos Biopharma Clinical Advisory Board.