The share price of Oramed Pharmaceuticals, an Israeli company listed on the Tel Aviv Stock Exchange and Nasdaq, and which is developing an insulin capsule, has risen 80% within a month, following a successful Phase II clinical trial. The trial results were published on November 12, but Oramed's share price only began rising after the company explained the results and the structure of competition in the market to investors, both in meetings and in its financial statements. The share price has receded from the peak it reached last week, which brought it to double the price before the results were published. At the start of today's session on the Tel Aviv Stock Exchange, Oramed's market cap was NIS 279 million.
In the trial, patients diagnosed with type 2 (adult) diabetes who had not begun injecting insulin were treated with Oramed's insulin capsule. While many experts regard taking insulin at a fairly early stage after diagnosis as beneficial, many patients want to postpone insulin injections as long as possible. Oramed seeks to address this conflict.
Oramed's capsule is not suitable for replacing injections among patients who are completely dependent on insulin, and who are in need of frequent and very accurate treatment. The market of patients in an intermediate state, however, is also a very large one.
The results were statistically significant, and according to Oramed, were also clinically meaningful. Patients treated for 12 weeks with a dosage of one capsule per day reduced their mean A1C score, the primary efficiency endpoint, by 0.60%, or by 0.54% adjusted for placebo (p value = 0.036), while patients treated with a dosage of two capsules achieved a reduction of 0.53% more than the placebo group (both of these results are statistically significant). Oramed said that a 0.54% reduction in A1C would reduce diabetes complications. The safety profile was satisfactory.
The results were not perfect, because a dosage of three times a day did not result in significant improvement. The company says that in view of the results at a lower dosage, it in any case prefers not to opt for a thrice-daily regime. "We are still examining the reason for the difference between the trial arms," Oramed said in its reports.
There is currently no insulin capsule on the market, although a number of companies in the diabetes sector previously attempted to develop such a capsule. Novo Nordisk recently obtained approval for an oral capsule containing the GLP1 drug, which causes the body to secrete more insulin. This capsule is usually used to supplement insulin treatment.
Oramed is scheduled to meet with the US Food and Drug Administration (FDA) next March to design its Phase III trial. It appears that two Phase III trials will be conducted - the usual practice for products in large markets. The patients in these trials will be tested for six months. Oramed believes that success in the two trials could lead to the submission of a request for marketing approval in late 2024.
CEO Nadav Kidron founded Oramed in 2000 on the basis of a technological development by his mother, Prof. Miriam Kidron, a researcher and doctor at Hadassah Medical Center. The company has raised $87 million to date. Oramed was merged into a US over-the-counter stock exchange shell in 2006, and made it to the main Nasdaq exchange in 2013. The company has been listed on the TASE since July 2017, after which its share lost 44% of its value, including the recent surge.
Published by Globes, Israel business news - en.globes.co.il - on December 5, 2019
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