PTG-100 inhibits a protein known as alpha-4-beta-7 integrin that is associated with IBDs. Scientists consider it one of the most important targets for therapies to alleviate the conditions.
Protagonist is conducting a global Phase 2b clinical trial (NCT02895100) to assess PTG-100 capsules’ ability to improve moderate to severe ulcerative colitis. The 240 patients are receiving one of three doses of PTG-100 a day — 150, 300 or 900 mgs — or a placebo, for 12 weeks. Researchers are still recruiting participants.
“These new patents further strengthen the long-term intellectual property protection for these clinical-stage assets, both of which have emerged from our innovative peptide technology platform,” Dr. Dinesh Patel, the president and CEO of Protagonist, said in a press release.
In a related development, Protagonist announced a second patent on its development of synthetic peptides that can mimic hepcidin, a hormone that regulates the body’s iron levels. A peptide is a small protein.
These peptides, which include PTG-300, are designed to regulate iron disorders that cause anemia.
Protagonist has completed a Phase 1 trial of PTG-300 in healthy people. It plans to start Phase 2 studies this year of PTG-300’s ability to treat patients with beta-thalassemia or a myelodysplastic syndrome.
Beta thalassemia reduces the production of hemoglobin, the iron-containing protein in red blood cells that carries oxygen throughout the body. Myelodysplastic syndromes are cancers that stem from the failure of immature blood cells in bone marrow to develop into healthy blood cells.
In addition to PTG-100, Protagonist is developing a bowel disorder therapy called PTG-200 that it initially intends as a treatment for Crohn’s disease. It believes the medications can significantly improve treatment of the conditions.
PTG-200 is an oral therapy that blocks the interleukin-23 receptor linked to bowel disease. Protagonist is testing it in a Phase 1 trial.
The company has formed a partnership with Janssen to develop and market PTG-200 for bowel disease and other disorders.