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On October 16, Oramed announced to its shareholders that based on guidance from the FDA, as part of the end-of-Phase II meeting process, the company has submitted FDA protocols for two upcoming pivotal Phase III studies for its oral human insulin candidate, ORMD-0801. ORMD-0801 is a prandial/short-acting insulin that is administered orally in pill form. The first study will treat type 2 diabetes (T2D) patients with poor glycemic control who are currently on 1–3 oral glucose-lowering agents, to evaluate the efficacy of ORMD-0801 compared to placebo in terms of glycemic control (A1c) with a secondary endpoint of change in fasting plasma glucose at 26 weeks.

The second Phase III study will treat patients with poor glycemic control who are managing T2D with just diet or with diet and metformin monotherapy, to evaluate the efficacy of ORMD-0801 compared to placebo in terms of glycemic control (A1c) with a secondary endpoint of change in fasting plasma glucose at 26 weeks. Oramed plans to begin patient enrollment for both studies this quarter across multiple sites throughout the US, EU, and Israel, and will have a treatment period of 6–12 months.

GlobalData believes that oral insulins could disrupt the major players in the insulin market due to their potential for greater compliance, which could allow them to displace subcutaneous prandial insulins, as patients tend to be injection-averse and would benefit from an oral option.

Phase II ORMD-0801 trials (with all patients on metformin) revealed a significant A1c lowering with a once-daily treatment, with no increase in adverse or hypoglycemic events compared to placebo. However, it will be important to observe the effects of ORMD-0801 in sequence with other oral glucose-lowering agents such as sodium-dependent glucose cotransporter inhibitors, to ultimately realize the potential for the oral insulin. Key opinion leaders (KOLs) have stated that there is a large need, and opportunity, for insulins that will cause less hypoglycemia. Oramed’s Phase IIb trial showed no increase in hypoglycemic events compared to placebo.

An additional benefit of the oral insulin is the lower cost to manufacture. Oramed CEO Nadav Kidron is confident that the cost of the oral insulin pill will be significantly lower than the cost of insulin injections. In the US especially, researchers found that many diabetic patients ration their insulin due to their high cost.

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Currently, MannKind’s Afrezza is the only marketed non-injectable (inhaled) mealtime insulin in the US. Generex recently launched Oral-lyn, an oral insulin spray, in India through Shreya Life Sciences, and is currently in Phase III in the US. Diasome Pharmaceuticals also has an oral insulin based on its hepatic-directed vesicle technology that completed Phase II and has FDA approval for Phase III trials in the US.