Oramed's Insulin Capsule Fails Its First Phase III Trial


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Diabetic patients tired of injecting their insulin will have to put up with the mode of delivery for the foreseeable future.

Oramed, a clinical-stage company developing orally available versions of biologic drugs, reported disappointing news regarding its lead candidate, ORMD-0801, on Thursday, Jan. 12th. 

Top-line results of a 710-patient, Phase III study with type 2 diabetes patients failed to meet the trial’s primary endpoint, a reduction in baseline A1C levels compared to a placebo after 26 weeks of treatment.

Oramed develops oral delivery routes for biological drugs that are traditionally injected. In addition to ORMD-0801, it has two candidates in clinical-stage testing. ORMD-0901 is an oral GLP-1 candidate in Phase I testing as a treatment for type 2 diabetes; it’s also developing an oral COVID-19 vaccine in early-stage clinical trials.

"Today's outcome is very disappointing, given the positive results from prior trials,” said Nadav Kidron, Oramed’s CEO, in a prepared statement. 

In a Phase II study that read out top-line results in 2020, patients with type 2 diabetes treated with ORMD-0801 exhibited an A1C reduction that was 0.81% stronger than patients given a placebo.

Kidron said Oramed would share its plans once complete data from its failed Phase III study becomes available.

In September, the company reported successful safety results of a Phase II trial with ORMD-0801 and non-alcoholic steatohepatitis patients. Participants who received the orally available insulin capsules showed a liver fat reduction trend that favored its candidate, but the efficacy results stopped short of statistical significance. 

Oramed’s second most advanced new drug candidate, ORMD-0901, is an orally-available version of AstraZeneca’s aging GLP-1 analog, Bydureon. 

First approved as an injection for type 2 diabetes patients in 2005, Bydureon’s share of the GLP-1 market has fallen in recent years to semaglutide, another GLP-1 that the FDA first approved in 2017. If ORMD-0901 advances, it could eventually contend with Rybelsus, an oral version of semaglutide that Novo Nordisk launched in 2019.

Oramed has a few years to figure out its next steps. 

When the company last reported earnings, it had $160 million in cash and short-term investments after operations burned through $30.9 million during the first nine months of 2022.

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