Tuesday, June 14, 2016 11:37:15 AM
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.
Recent ORMP News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/23/2024 12:06:24 PM
- Form SC 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 09/16/2024 08:42:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 08:05:24 PM
- Oramed Letter to Shareholders • PR Newswire (US) • 06/26/2024 01:05:00 PM
- Oramed Pharmaceuticals Inc. Announces the Buy-Back of its Common Stock • PR Newswire (US) • 06/26/2024 01:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 06/20/2024 11:32:05 AM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/20/2024 11:30:08 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/10/2024 09:28:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/10/2024 09:15:29 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 09:00:57 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 01:00:27 PM
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- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/06/2024 10:00:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 01:42:26 PM
- Oramed Letter to Shareholders • PR Newswire (US) • 02/20/2024 01:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/30/2024 10:30:32 PM
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