Clinical Trials Arena

Oramed to reinitiate pivotal type 2 diabetes trial after Phase III flop

Following a review of the trial data, Oramed discovered that the oral insulin candidate was effective in a particular subset of patients.

Oramed Pharmaceuticals has announced it is looking to reinitiate a Phase III trial of its oral insulin candidate in type 2 diabetes (T2D) after the previous pivotal trial failed to meet its endpoints.

The company revealed in a letter to shareholders that since the failure, it had completed an in-depth review of the trial data from the trial of its oral insulin candidate ORMD-0801 following the previous failure of its candidate in a US trial in January 2023 (NCT04606576).

The review revealed that subpopulations of patients within specific parameters such as body mass index (BMI), baseline haemoglobin A1C (HbA1c), and age responded well to oral insulin. These patients showed a statistically significant reduction in HbA1c.

As a result of the analysis, the company has started discussions with the US Food and Drug Administration (FDA) to initiate a Phase III trial of the candidate in the US using an amended protocol later this year.

ORMD-0801 is an insulin receptor agonist. Insulin acts by binding to the insulin receptors to reduce blood glucose.

Oramed is in a joint venture partnership with China-based Hefei Tianhui Biotechnology (HTIT). HTIT recently completed a Phase III trial of oral insulin in China and is coming to the final stages of regulatory approval.

Oramed says it hopes the deal will help with the completion of the newly announced Phase III trial in the US, as well as being able to utilise production capabilities.

Type 2 diabetes landscape

The T2D field is strong with both Novo Nordisk and Eli Lilly currently at the helm of glucagon-like peptide-1 receptor agonist (GLP1Ra’s) medications. Novo Nordisk is the market leader in the space with a value market share of 65.2%, according to GlobalData.

Novo Nordisk’s biggest candidate is semaglutide, marketed as Ozempic, with GlobalData predicting a global sales forecast of $44bn in 2029.

Meanwhile, Eli Lilly’s main candidate tirzepatide, which is marketed as Mounjaro has a predicted global sales forecast of $33.4bn in 2029.

Both candidates have also been approved for use in obesity under the names Wegovy and Zepbound respectively. Their sales forecasts also include this market.

GlobalData is the parent company of the Clinical Trials Arena.