Drug company Kamada Ltd. (TASE: KMDA) announced today that it had attained positive results, meeting the primary endpoint, in a phase 2 trial of its Alpha-1 Antitrypsin Deficiency (AATD) treatment. Following this announcement, Kamada's stock jumped 13%, and the company is traded at a market cap of NIS 680 million.
The trial was carried out in the US, and is aimed at future registration of the product there. However, this success will also have an effect on Kamada operations in Europe, which might take shape earlier than expected.
Two years ago, the company had an unsuccessful phase II/III trial of an inhaled AATD treatment drug, after failing to meet the primary endpoint of the trial (preventing seizures). As a result, the company's share price dropped 35% and it is yet to recover fully. Kamada claimed that it attained one of the trial's secondary endpoints (improving routine lung functions), that the original test outline had become outdated, and that the secondary goal should have been the primary one. The European Medicines Agency (EMA) authorized Kamada to file its application, while focusing on lung functions, an objective that, as mentioned, had been attained in the trial.
The current trial, which involved only 36 patients, but included both a control group and a test group, did not measure lung functions or seizures, but rather the amount of Alpha-1 Antitrypsin (AAT) protein that Kamada's product managed to bring to the lungs
AATD is characterized by a deficiency in AAT protein, and the rationale for all treatments, already marketed worldwide for hundreds of millions of dollars, is that reclaiming the protein is beneficial to AATD treatment (although this has never been proven in an official clinical trial). Kamada's product managed to use inhalation to more effectively increase AAT levels in the lungs, compared with available transfusion treatments. As part of the EMA's dialogue with Kamada on the drug's approval, it inquired in the past about the drug's operation mechanism and the amount of AAT that reaches the lungs.
In the past, Kamada has reported that it expects the EMA to provide a response no earlier than mid-2017. In early 2017, further results from the current trial are expected, which will enable the company to reach an understanding with the US Food and Drug Administration (FDA) on further development of the treatment.
Published by Globes [online], Israel business news - www.globes-online.com - on August 30, 2016
© Copyright of Globes Publisher Itonut (1983) Ltd. 2016