Clinical Trials

 

The Phase 3 Clinical Trial DIA-AID 2 is an open label, 24 month extension study that has been designed to evaluate long term safety, tolerability, and the effect of DiaPep277®on the ability of patients to maintain glycemic control for two additional years following the completion of the DIA-AID 2 confirmatory study.  DIA-AID 2 is scheduled to be completed at the end of 2014. This extension study will be conducted in medical centers in the USA, Europe, and Israel.
Patients who are eligible to be enrolled in the extension study are those who have completed two years of treatment in the DIA-AID 2 trial and have residual beta cell function (stimulated C-peptide not less than 0.2 nmol/L) regardless whether they were on the actual drug or on the placebo.All eligible patients will be treated with subcutaneous injections of 1 mg of DiaPep277® given quarterly for two additional years.

This extension study is part of a clinical development plan which was presented to the regulatory authorities in Europe and in the USA.

 

* On September 18, 2014, Evotec announced after careful evaluation that it will take legal steps against Andromeda Biotech to recover all Evotec claims and potential damages that result from recent incidents in relation to DiaPep277®. Hyperion Therapeutics, recently announced that it uncovered evidence that certain employees of Andromeda in collusion with a third-party biostatistics firm in Israel engaged in serious misconduct with regard to the use of generated data in order to manipulate the analyses to obtain a favourable result of the Phase III trial (see below). In 2007, DeveloGen sold all rights to the drug candidate DiaPep277® to Andromeda, a newly formed wholly owned subsidiary of Clal Biotechnology Industries Ltd. Under the terms of this asset purchase agreement, DeveloGen transferred all rights in DiaPep277® to Andromeda in return for single-digit royalty rates and certain milestones in the single-digit rate upon commercialisation of DiaPep277®. Evotec, which acquired DeveloGen in 2010, had no involvement in any aspect or decision-making regarding the development of DiaPep277®. Similarly, Evotec’s subsidiary DeveloGen, was also not involved in any way in the further development of DiaPep277® after selling it to Andromeda in June 2007, and had absolutely no role in the data generation and analyses. Consequently in light of the recent developments with DiaPep277®, Evotec has decided to take legal steps against Andromeda to recover all Evotec claims and potential damages that result from this recent fraudulent activity.

* On September 8, 2014, Evotec announced that the company was informed that US company Hyperion Therapeutics is terminating the development of DiaPep277® for newly diagnosed Type 1 diabetes. Hyperion has stated that it has uncovered evidence that certain employees of Andromeda Biotech, which Hyperion acquired in June 2014, engaged in serious misconduct, involved with the trial data of DiaPep277®. Hyperion announced that this misconduct included collusion with a third-party biostatistics firm in Israel to improperly receive un-blinded DIA-AID 1 trial data and to use such data in order to manipulate the analyses to obtain a favorable result. Additional evidence indicates that the biostatistics firm and certain Andromeda employees continued the improper practice of sharing and examining un-blinded data from the ongoing DIA-AID 2 trial. All of these acts were concealed from Hyperion and others. Hyperion has suspended the Andromeda employees known to be involved, and the company is notifying relevant regulatory authorities, and continues to investigate in order to explore its legal options. Hyperion employees were not involved in any of the improper conduct.

Hyperion will complete the DIA-AID 2 Phase 3 trial, but will terminate further development in DiaPep277®. "This new information leaves us with no viable regulatory path forward," said Donald J. Santel, president and chief executive officer. "We're shocked and disheartened at the serious misconduct and deceit by the implicated Andromeda employees, both before and after the close of our transaction. Patients and clinical investigators invested years of their lives in the expectation of an honest result. We will be engaging with clinical investigators and are prepared to complete the DIA-AID 2 trial because the data may still yield useful insights into the natural history of Type 1 diabetes. However, we will not invest further in DiaPep277 beyond completing the DIA-AID 2 trial and meeting our obligations to close out the investigational program as a whole." The last patient visit in the DIA-AID 2 trial is anticipated to occur in the fourth quarter of 2014. The company expects to record a non-cash impairment charge in the range of $25 million to 55 million. DiaPep277® is also one of Evotec’s advanced pipeline projects, where Evotec is entitled to royalties and milestones. Given the situation of the programme Evotec does no longer expect this project to hit the market. Therefore, the company expects to record a non-cash impairment charge of € 8.7 million. In addition, Evotec still has an open receivable against Andromeda/Hyperion, which amounts to € 3.4 million, the payment of which is required for Evotec to meet its profitability in 2014. 

* On December 18, 2013, Andromeda Biotech has announced that the first patient was dosed with DiaPep277® for the treatment of type 1 diabetes in its Extension Study to the Phase 3 Clinical Trial DIA-AID 2. Patients who are eligible to be enrolled in the extension study are those who have completed two years of treatment in the DIA-AID 2 trial and have residual beta cell function (stimulated C-peptide not less than 0.2 nmol/L) regardless whether they were on the actual drug or on the placebo. The extension study is expected to be completed at the end of 2016.