The development of DiaPep277, a type 1 diabetes drug, has been temporarily halted due to the manipulation of trial data.
Hyperion, a United States-based company, had agreed to complete the Phase III trial for the drug upon purchasing Andromeda Biotech from Clal Biotech in June 2014. The milestone payments of the deal meant that Hyperion parted with sums of up to $570 million.
In September, Hyperion found that employees of Andromeda were engaged in “serious misconduct” which led to data being falsified in order for the trial to display a favourable result.
Citing the allegedly tainted results, Hyperion cancelled its acquisition of Andromeda from Clal Biotech. Subsequently, Clal have sued Hyperion in a US court for $200 million, with both companies agreeing to resolve their dispute after Hyperion halted development.
Clal will now appoint an independent party to evaluate any clinical efficiency in a freshly assessed study of DiaPep277 to analyse a potential regulatory path for the drug.
What is DiaPep277?
The DiaPep277 drug is a peptide designed to protect the internal production of insulin in patients who have recently been diagnosed with type 1 diabetes. It works by stimulation of regulatory responses to prevent the immune destruction of insulin-producing beta cells in the pancreas.
These revelations …read more
Source:: News from Diabetes.co.uk