Positive update from European Medicine Agency on NTCD-M3 phase III development plans to prevent C,difficile
Destiny Pharma plc a late-stage clinical biotechnology company focused on the development of novel products to prevent life-threatening infectious diseases, is pleased to announce that it has received positive feedback from the European Medicine Agency (EMA) on the proposed NTCD-M3 Phase III development programme
NTCD-M3 is the lead clinical candidate being developed by Destiny Pharma for the prevention of the recurrence of infections caused by toxic strains of the gut bacteria Clostridioides difficile, which can cause significant inflammation and damage to the gut leading to an estimated 29,000 deaths annually in the US alone, a number comparable to the yearly deaths from prostate cancer. It is estimated CDI adds an extra $6 billion to US healthcare costs per annum while in Europe, the economic burden caused by CDI is estimated at $3 billion and increasing.
The key points from the EMA’s feedback are that they have agreed: i. With the overall comparability plans relating to the development of the new easy-to-use capsule formulation of NTCD-M3, thus lifting any requirements for human trials to demonstrate such comparability. ii.That the proposed single trial Phase III design to be sufficient for a MAA (Marketing Authorisation Application) also endorsing the primary and secondary endpoints of the proposed Phase III study .iii.That the overall proposed safety database will be collected through the conduct of the proposed Phase III trial and that this would be sufficient for a MAA. iv. To remove the requirement of a thorough QT study (a study which is used to measure the potential impact of a drug on the heart function) for NTCD-M3 development programme.
With EMA’s feedback received, Destiny Pharma is now focused on finalising the manufacturing and formulation of NTCD-M3 clinical trial material and on the detail of the global Phase III study with the aim of enrolling the first patient in the USA and potentially in Europe/rest of the world, towards the end of 2023. The Company is currently seeking partners to co-fund the Phase III clinical programme and take responsibility for the approval and commercialisation of NTCD-M3.
The NTCD-M3 development focuses on patients with a primary episode of CDI and first recurrence. Thus, it is clearly differentiated from other products in development as NTCD-M3 is positioned as an early intervention to reduce the risk of recurrences.
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