Clinical Trials

* On August 12, 2014, Cortendo announced that the first patient has been enrolled into the Phase 3 SONICS trial, i.e., “Study Of NormoCort In Cushing’s Syndrome.” The patient was enrolled by one of the trial’s lead principal investigators at a Pituitary Center from a prestigious institution in Baltimore, Maryland. Cortendo successfully completed its European Investigator meeting supporting SONICS held in Barcelona, Spain on July 17-18. More than 35 investigators/study coordinators, including many of the world’s leading Cushing’s experts from 24 study sites, were in attendance and received training for the trial. Based on the positive feedback from the meeting, Cortendo has gained further confidence that NormoCort (COR-003) has the potential to be an important future treatment option for patients afflicted with Cushing’s Syndrome. A second US Investigator meeting is also being planned for later this year.

Cortendo has also further strengthened its internal as well as external teams to support the study and to position the trial for an increased recruitment rate. In July, Cortendo added both an experienced physician and internal Clinical Operations Director to the NormoCort development team. Cortendo, working in concert with its CROs supporting the SONICS trial, now has a team of approximately 20 personnel on the NormoCort development program. Cortendo has previously communicated its plan to meet the recruitment goal by increasing the number of study sites from 38 to 45 worldwide. The company is at various levels of activation with more than 30 study sites to date. Therein, Cortendo expects a large proportion of the sites to be activated by the end of the third quarter this year and remains confident that essentially all sites will be open by the end of 2014.

* On July 9, 2014, Cortendo reported continued progress in the implementation of the Phase 3 SONICS trial, i.e., “Study Of NormoCort In Cushing’s Syndrome” for NormoCort®. In addition to the US IND and UK CTA approvals announced previously, Cortendo has now received additional approvals in Spain, Belgium, Netherlands, France, Israel, Sweden and Denmark bringing the total country approvals to nine. Cortendo has also further strengthened its internal as well as external teams to support the study and to position the trial for an increased recruitment rate. Cortendo, working in concert with its CROs for the SONICS trial, now has a team of approximately 20 personnel supporting NormoCort development. In addition, Cortendo’s European Investigator meeting supporting SONICS will occur in the upcoming weeks with 25 study sites being represented (chiefly from the EU and US) by either the investigator and/or the study nurse coordinator at this key meeting. A second US Investigator meeting is also being planned for the early autumn. While Cortendo expected faster implementation of the start-up phase, we believe that the overall effort is bearing fruit and is showing noticeably higher effectiveness. Cortendo plans to meet the recruitment goal by increasing the number of study sites from 38 to 45 worldwide. The company is at various levels of activation with more than 30 study sites to date. Therein, Cortendo expects a large proportion of the sites to be activated by the end of the third quarter this year and remains confident that essentially all sites will be open by the end of 2014. The Company continues to project meeting its recruitment target of 90 patients in total by Q4 2015.

* On July 30, 2013, Cortendo has announced that it has received its first authorization to conduct a clinical study with NormoCort™ (COR-003) in the European Union (EU) from the MHRA in the UK. The authorization is conditional on minor changes to the Phase 3 protocol that have been agreed on and will be implemented by Cortendo. This first authorization in the EU will add to Cortendo’s open IND for NormoCort™ in the US. (see below) Cortendo is in the process of conducting remaining pre-study start up activities necessary to support patient enrollment for trial initiation later this year. During this time period Cortendo will also discuss final protocol study design considerations with regulatory agencies to assure a uniform protocol across the regions. The results from this pivotal trial, if successful, would form the basis of the US NDA and European MAA filings for NormoCort™.

* On June 25, 2013, Cortendo has announced that after receiving EMA scientific advice earlier this year on NormoCort™ in development for Cushing’s syndrome, it has now filed its first European Clinical Trial Application (CTA) for the drug. This first application to the UK’s MHRA will add to Cortendo’s open IND for NormoCort™ in the US. "Cortendo continues to execute on its regulatory strategy to conduct a single pivotal Phase 3 trialin the US, Europe and other countries", said Dr. Theodore Koziol, Cortendo’s COO. 

* On May 30, 2013, Cortendo has announced that it has received regulatory clearance by the FDA to initiate a pivotal Phase 3 trial with NormoCort®, an investigational new drug for Cushing’s Syndrome. Additionally, Cortendo is planning to submit Clinical Trial Applications (CTAs) supporting the pivotal trial in key European countries. The results from this pivotal trial, if successful, would form the basis for the US NDA and European MAA filings for NormoCort® in both regions. Over the next months, Cortendo will be completing remaining pre-study activities necessary to support the planned single US/EU pivotal Phase 3 trial in Cushing’s syndrome.

Cortendo’s business strategy is to commercialize NormoCort® in the US by itself if the development is completed successfully.

In 2012, NormoCort® was granted orphan drug designation by the FDA for the US and by the EMA for the EU. NormoCort® has an issued patent in Europe (EP 1853266B1) and a similar patent has been filed in the US.