On January 4, the company announced slightly murky data from its first-in-patients 12-week Phase II proof-of-concept trial of BT-11 for mild to moderate ulcerative colitis.
Landos Biopharma filed yesterday with the U.S. Securities and Exchange Commission (SEC) to launch an initial public offering (IPO). The company intends to raise $100 million. The company is a spinout from Virginia Tech, and a lead company in Chris Garabedian’s fund at Perceptive Advisors.
On January 4, the company announced slightly murky data from its first-in-patients 12-week Phase II proof-of-concept trial of BT-11 for mild to moderate ulcerative colitis. The drug is a novel, orally administered, gut-restricted LANCL2 modulator. The trial enrolled 198 UC patients at 53 sites in the U.S., Europe and Russia. There were two dosing cohorts, 500 mg and 1,000 mg compared to placebo. Clinical remission was evaluated over a 12-week induction period, which was defined by the 3-component modified Mayo Score, using a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1.
There was a positive trend in absolute clinical remission rates for both doses: 31.8% for 1,000 mg; 30.3% for 500 mg; 22.7% for placebo. The placebo-adjusted clinical remission rates were 9.1% for the 1000 mg dose and 7.6% for the 500 mg dose.
Essentially, the trial missed all its primary endpoints in IBD, although there were some positive signs, after adjusting for placebo values, that it was similar to standard of care.
“We are excited by the very promising Phase II trial results evaluating BT-11, as it marks the first potential therapeutic to engage the novel target LANCL2,” said Josep Bassaganya-Riera, chairman, president and chief executive officer of Landos. “We believe this novel mechanism of action is responsible for modulating key immunological mechanisms associated with various autoimmune diseases such as ulcerative colitis and Crohn’s disease.”
He went on to note that the proof-of-concept data de-risked the drug and offered validation of the LANCL2 pathway, as well as the company’s advanced modeling and artificial intelligence-based LANCE precision medicine platform, “which efficiently identifies immunometabolic targets and develops novel product candidates designed to engage these conserved pathways, providing durable therapeutic activity. Building on the momentum from this Phase II trial, Landos will continue expanding its robust therapeutic inflammation and immunology pipeline, which currently contains seven product candidates based on novel immunometabolic mechanisms targeting a wide range of autoimmune diseases.”
The LANCL2 pathway, which stands for Lanthionine Synthetase C-Like 2, is a membrane receptor that modulates immune mechanisms tied to autoimmune diseases.
Landos plans to initiate a Phase III trial of BT-11 for ulcerative colitis and a Phase II trial of the drug for moderate to severe Crohn’s disease in the first half of this year.
The company plans to list on the Nasdaq under the LABP ticker symbols. It will remain to be seen if the Phase II trial’s data, which had disappointing p-values, forcing it to miss the primary endpoints, will discourage investors, or if the promise of the company’s overall approach will stimulate intrigue and interest.
In July 2020, Landos dosed the first patient in its Phase I trial of NX-13, its novel, orally administered drug for inflammatory bowel disease. It’s a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort Phase I trial looking at safety, tolerability, and pharmacokinetics of NX-13 in healthy volunteers.
At the time, Jean-Frederic Colombel, a Clinical Advisory Board member for the company’s IBD program and a gastroenterologist and director of the IBD Center at the Icahn School of Medicine at Mount Sinai, stated, “Advancing two first-in-class oral products for Crohn’s disease and ulcerative colitis with new mechanisms of action into clinical development in less than two years is a substantial accomplishment. We continue to see an unmet clinical need for chronic oral therapies to treat UC and CD with improved efficacy, safety, tolerability and convenience, including in the mild to moderate patients.”
