Destiny Pharma PLC (AIM:DEST) said it has received some positive feedback for its phase III clinical trial of a new antibiotic treatment from the regulators at the European Medicines Agency (EMA).
Specifically, the EMA has said a single, final-stage study of NTCD-M3 will be enough for it to make a marketing authorisation application.
It has also endorsed a new capsule formulation of the drug, which is being developed to treat the recurrence of C. difficile infection (CDI).
In particular, the watchdog has removed the requirement to show comparability of the new formulation of the treatment to the previous iteration.
The phase III trial is expected to recruit around 800 people with the aim of showing that NTCD-M3 can successfully prevent the recurrence of CDI, a gut infection that can be fatal.
The plan is to make regulatory applications both in Europe and the US, where it expects to make a biological licence application to the US Food & Drug Administration (FDA).
Destiny’s chief medical officer, Dr Yuri Martina, said NTCD-M3 had previously shown ‘impressive efficacy’ with recurrence rates reduced to around 5% when the Destiny drug was used immediately after the antibiotic treatment for CDI had been completed.
“As a physician, being able to prevent patients with CDI to go down the path of multiple recurrences is truly a game changer for the treatment of this disease,” he added in a statement.
In a separate announcement, the company said its chief executive Neil Clark would be presenting at the HC Wainwright 24th Annual Global Investment Conference on September 12, 2022. The event is being held in New York and virtually.