Since Octreolin is an oral drug, it will be tested to determine if it enables continuation of portal hypertension inhibition once patients are stabilized and discharged from the hospital.
Octreolin is designed to improve patient quality of life, prevent or reduce bleeding events and lower mortality rates of PHT patients, of which there are 80,000 in the US, and an equal number in Europe. Octreolin for PHT will be the subject of Orphan Drug applications in the US and Europe and will be developed under the auspices of the 505(b)(2) regulatory pathway in the US and its EMEA equivalent, the Hybrid Application.
Roni Mamluk, PhD, Chief Operating Officer said, "This first proof-of-concept of the utility of the TPE technology in humans is promising not only for the Octreolin product and potentially the many patients that will benefit from its use if approved, but also for the validation of the platform for other drugs that we are developing. Our research pipeline includes small molecules, peptides and proteins that could not only benefit from a switch to oral delivery but importantly will be studied in new indications as well as in those instances in which improved labels could significantly augment efficacy or reduce side effects."
Fredric Price, Chairman and CEO commented, "Our corporate strategy is two-fold: (1) to develop our own proprietary products and seek out partnerships outside of the US after demonstrating clinical effectiveness and safety; and (2) to enter into arrangements with companies whose important drugs could benefit from the TPE technology.
|SOURCE Chiasma, Inc.|
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