Destiny Pharma receives 'positive feedback' from EMA on NTCD-M3

7th Sep 2022 08:06

(Sharecast News) - Clinical stage biotechnology company Destiny Pharma has received "positive feedback" from the European Medicine Agency regarding the proposed Phase III development programme of its new antibiotic treatment.

Destiny Pharma said on Wednesday that the EMA had declared that a single, final-stage study of NTCD-M3, the group's lead clinical candidate for the prevention of the recurrence of infections caused by toxic strains of the gut bacteria, would be sufficient for it to file a marketing authorisation application.

The AIM-listed group added that the EMA also endorsed a new capsule formulation of the drug, currently in development with an aim to treat the recurrence of Clostridioides difficile.

Destiny will look to recruit around 800 people as part of the phase III trial and hopes to show that NTCD-M3 can successfully prevent the recurrence of CDI - a gut infection that can be fatal. Destiny will then look to make regulatory applications in both Europe and the US.

Chief medical officer Dr Yuri Martina said: "NTCD-M3 is a unique microbiome product being a single strain of non-toxigenic Clostridioides difficile. This targeted mode of action differentiates it from FMT (faecal microbiota transplantation) or other multiple strains or consortia microbiome products and NTCD-M3 also has advantages from a safety and longer-term risk perspective.

"As a physician, being able to prevent patients with CDI to go down the path of multiple recurrence is truly a game changer for the treatment of this disease."

As of 0910 BST, Destiny Pharma shares were up 2.53% at 38.45p.

Reporting by Iain Gilbert at Sharecast.com