Chiasma Phase III acromegaly trial meets all endpoints


Chiasma hopes for approval of its drug, which can be taken orally, by mid-2020.

Israeli drug development company Chiasma Inc. (Nasdaq: CHMA) today announced that it had achieved good results in its Phase III clinical trial of its product for treatment of acromegaly. The trial met its main endpoint and all of its secondary endpoints. Chiasma's current market cap on Nasdaq is $196 million. The share is up 24% on Wall Street today.

The good results have come after the Ness Ziona-based company has overcome innumerable obstacles: a clinical trial that the company was unable to reproduce; replacement of its entire management; restructuring and a strategic change with a focus on the company's new product; a sale of the rights to Chiasma's product to Roche for a sum potentially in the hundreds of millions of dollars, followed by Roche's return of the product to Chiasma; an independent clinical trial by the company; an unexpected answer from the US Food and Drug Administration (FDA) that another trial would be required; another replacement of most of the company's management; and belt-tightening in preparation for performing the extra trial.

The current trial was conducted under a protocol devised together with the FDA, and the company therefore believes that the data will be enough this time for approval of the product.

Acromegaly is a disease that features excessive growth hormone, leading to exaggerated growth, accompanied by side effects. Patients suffer from irregular height and a short life expectancy (the actor who played Fezzik in "The Princess Bride," whose stage name was Andre the Giant, had the disease). The disease is now rare, because it is treated with a drug marketed by Novartis. This drug, however, requires painful injections, while Chiasma's drug contains the same active ingredient, but can be taken orally.

The trial showed that the product is both safe for use on patients and effective. The trial compared the product with a placebo, not with Novartis's product. 90% of the patients who participated in the trial chose to continue with Chiasma's product. The company hopes to submit its product for approval by the end of the year in the hope of receiving approval by mid-2020.

78% of the patients in the trial kept a desirable low level of growth hormone. Only 25% of the patients also asked for an injection of Novartis's drug during the trial.

Chiasma is simultaneously conducting a trial to examine the effect of its product in the long term. This trial compares the product to injections for the first time. Results of the trial are expected towards the end of 2020. Good results in this trial are likely to support the product in Europe, and could also support marketing of the product in the US if it is approved there by mid-2020.

Chiasma had $58 million in cash as of the end of June 2019, after raising $34 million in early April. The company is managed by CEO Raj Kannan, former head of neurology and immunology at Merck.

Published by Globes, Israel business news - - on July 23, 2019

© Copyright of Globes Publisher Itonut (1983) Ltd. 2019

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