Applied Molecular Transport Inc. (NASDAQ: AMTI) announced positive results for its AMT-101 therapy. This treatment is for chronic pouchitis patients. The drug is GI-selective and given to the patient once daily. It contains IL-10 and a molecular therapy, which the company is developing for rheumatoid math and ulcerative colitis.
The purpose of the study was to evaluate the drug’s efficacy and safety. It was also to help researchers find a suitable dose for Phase III. The researchers assessed two endpoints when it came to the drug’s efficacy. These are physiological healing and symptomatic improvement. They measured the latter by stool frequency response.
Patients improved after using AMT-101
According to a medical professor, Dr Brian Feagan, the study demonstrated that AMT-101 is safe and effective for patients with chronic pouchitis. Moreover, the drug gave remarkable results in patients with severe disease symptoms. It improved the lives of patients whose quality of life had been reduced by chronic pouchitis.
Dr Feagan adds that the histological and stool frequency gets the researchers took were positive after the researchers treated patients with AMT-101. For instance, patients experienced decreased stool frequency, improved urgency, reduced abdominal cramps and incontinence.
The company will share its findings with regulators
The company’s CEO Dr Bittoo Kanwar says that the company is glad to have made a breakthrough discovery due to the disease’s severity. Moreover, it is waiting to share its results with regulators like the U.S Food and Drug Administration (FDA). Kanwar adds that the results indicate that the drug could potentially treat patients with mucosal inflammation and immunology.
In the Phase II study, the company administers AMT-101 for 12 weeks. They gave 22 patients either 10mg or 3mg oral doses. Furthermore, they conducted the study in 33 sites in 11 countries. The patients used for the trial had failed one or more antibiotic therapies. The researchers also didn’t allow the use of rescue antibiotics.
Several ulcerative colitis patients (30%) undergo total colectomy. While the surgery is beneficial, about 60,000 people have pouchitis after the procedure. This condition is characterised by inflammation of the pouch lining. In 50% of cases, the condition is acute though other patients don’t respond to antibiotics and develop chronic disease.
