Destiny Pharma PLC on Wednesday announced that it had received positive feedback from the European Medicine Agency on its NTCD-M3 phase 3 development plans.
NTCD-M3 is the lead clinical candidate being developed by the Brighton-based biotechnology company for the prevention of the recurrence of infections caused by toxic strains of the gut bacteria clostridioides difficile.
The European Medicine Agency’s agreed with the overall comparability plans relating to the development of the new easy-to-use capsule formulation of NTCD-M3, lifting any requirements for human trials to demonstrate such comparability.
Additionally, they agreed that the proposed single trial phase three design is sufficient for a marketing authorisation application taking away the need for further trials.
Clostridioides difficile infection is estimated to cause 29,000 deaths annually in the US alone, a number comparable to the yearly deaths from prostate cancer.
It is estimated the infection adds an extra $6 billion to US healthcare costs per annum while in Europe, the economic burden is estimated at $3 billion and increasing.
If NTCD-M3 is successful in its planned phase three trials in around 800 patients, it will be approved under a biological licence application by the food and drug administration in the US for the prevention of recurrence in clostridioides difficile infection and under a market authorisation application in Europe.
Chief Medical Officer Yuri Martina said: ‘The NTCD-M3 strain only transiently colonises the patient’s intestine which means it protects from clostridioides difficile infection while allowing the normal microbiome to be rebuilt after antibiotic treatment.
‘Additionally, NTCD-M3 delivers an impressive efficacy with recurrence rates reduced to around 5% when used immediately after the antibiotic treatment for clostridioides difficile infection has been completed. As a physician, being able to prevent patients with clostridioides difficile infection to go down the path of multiple recurrence is truly a game changer for the treatment of this disease.’
Shares in Destiny closed 0.3% higher at 37.60 pence each in London on Wednesday.
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