Sanofi recruits 4943 patients in three clinical trials

Complementary clinical trials with Efpeglenatide & Metformin, 481 patients enrolled

Registration of 3 subjects in 2 years after the start of clinical trial at the end of 2017

Hanmi Pharmaceutical's new technology, "Efpeglenatide", exported to Sanofi, continues commercializing smoothly..

 

Three cases were recruited out of five phase III trials.

 

In three clinical trials, a total of 4943 patients were recruited, accumulating the scientific evidence to prove the competitiveness of Efpeglenatide.

 

The whole view of Hanmi Pharmaceutical Headquarters

According to Clinical Trials, a clinical information site run by the National Institutes of Health (NIH), Sanofi recently completed a recruitment of one of the Phase III trials of Efpeglenatide.

 

This is a Phase III clinical trial comparing the combination of Efpeglenatide and Metformin with the competing drug Trulicity ( Dulaglutide).

 

Sanofi began the trial in September 2018 and after enrolling 481 subjects, changed the clinical stage to “Active, not recruiting” on the 7th..

 

The target completion date is next February.

 

Sanofi has completed three of the five trials of Efpeglenatide in Phase III trials.

 

Efpeglenatide is a GLP-1-based diabetic drug that extends daily injections from once a week to up to once a month.

 

It is based on Hanmi’s 'Lapscovery' technology.

 

Lapscovery is a platform technology that increases the short half-life of biopharmaceuticals and reduces the number of doses and dosages to reduce side effects and improve efficacy.

 

Hanmi signed a technical export contract with Sanofi’s Efpeglenatide in November 2015, and holds the record of the largest contract ever for four years.

 

In November 2015, Hanmi signed a contract with Sanofi to export technology for a total of €3.9 billion in quantum projects (Efpeglenatide·sustained insulin· Efpeglenatide·sustained insulin).

 

The down payment is €400 million.

 

In December 2016, Hanmi signed an amendment agreement with Sanofi to return one of its technology transfer projects.

 

Hanmi returned €196 million to Sanofi out of the €400 million received from Sanofi.

 

Sanofi announced a detailed development plan at the end of 2017, two years after taking the rights of Efpeglenatide.

 

Sanofi began five clinical trials in late 2017 after the first phase III trial comparing Efpeglenatide to placebo.

 

In last June, 4076 people were enrolled in the AMPLITUDE-O, which is considered the core clinical trial of Efpeglenatide.

 

In last October, the recruitment of AMPLITUDE-M compared to placebo was completed.

 

A total of 4943 patients were enrolled in the three clinical trials that were completed.

 

It is accumulating scientific evidence to secure market competitiveness while demonstrating the safety and effectiveness of Efpeglenatide in large patients.

 

Efpeglenatide survived the reorganization of Sanofi's harsh R&D pipeline.

 

Efpeglenatide is the only diabetic drug among the five R&D pipelines that Sanofi has set for NDA within two years.

 

Sanofi suddenly stopped developing GLP-1 based triple agents (SAR441255) last year.

 

It also returned the rights of the SGLT-1/2 double inhibitor ‘Zynquista(Sotagliflozin)’, which was introduced in 2015.

 

Sanofi announced in last December that Sanofi increased its investment in four areas: cancer, blood disease, rare disease, and nervous system disease and stopped research into cardiovascular disease.

 

Efpeglenatide is in a position to complete development and search for a new vendor.