Oramed Pharmaceuticals Inc (ORMP)

[nyctraydr]

3 Biotechs That Just Announced Successful Phase 2 Trials

Oramed Pharmaceuticals

...Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) is going after one of the holy grails of the biotech/health care space: oral insulin. The company just reported top-line results from a Phase 2b as well, designed to gauge the safety and efficacy of its lead oral insulin candidate, the ORMD-0801 capsule.

The study measured its efficacy against a primary endpoint of a reduction of night-time glucose, as measured by way of a weighted mean. In 180 patients across a 28-day period, the drug demonstrated a mean reduction of night-time glucose to the tune of 6.47% between the active arm of the trial and the control placebo arm. Tolerability proved no real issue, with no serious adverse events reported in any patients — rare in a trial of this size.

Oral insulin has been elusive to biotech companies big and small to date, primarily due to the difficulty of getting the insulin to the liver without it being absorbed and digested on its way through the gastrointestinal tract. Oramed has designed ORMD-0801 to resist premature breakdown, and the trials to date look as though its design may be effective.

We should get some more detailed data across the next few weeks, and while a pivotal Phase 3 trial has not yet been announced, chances are it will be before the close of 2016.