Last week Israel-based Oramed unveiled safety data from a Ph IIa trial of its insulin pill candidate – ORMD-0801 – and announced that the drug had met primary and secondary endpoints in the 30-person study. It also promised to present full study results at an upcoming conference.
The claim – which would mean Oramed has taken the lead in the race to develop an insulin pill over rivals like Novo Nordisk and Biocon – was met with a mixed reaction.
Some reports welcomed it as a step forward, while others suggested the safety data were “completely worthless” without the rest of the trial results.
To try and clarify the situation in-Pharmatechnologist.com asked Oramed what impact the drug had had on the 30 type 2 diabetes patients who received it in the trial, however a spokesperson declined to comment and directed us to the publicly available safety data.
We also asked – assuming that the Phase IIa data do indicate what Oramed claim – how important it is to be first to market.
The spokesperson said that: “There will be the investor perspective and the reality of which method of oral insulin is actually the most successful, which only time can tell – and the two, investor opinion versus market reality, may or may not match up.”
Delivery technology
Oramed’s pill ORMD-0801 uses protease inhibitors, absorption enhancers and a pH sensitive coating to protective the drug active from digestive enzymes that would otherwise degrade it
When the safety data were announced last week Oramed CEO Nadav Kidron said they were a solid validation of the firm’s technology platform.
This was echoed by the spokesperson, who stressed the technology’s broad applicability and highlighted biopharmaceuticals as one area of potential application the firm is looking at.
“Our technology can be used to orally administer other proteins, the majority of which are only available via injection, currently, if the protein meets the specifications.”