Destiny Pharma PLC (LON:DEST) has said it is making good progress with preparations for its phase III trial of a breakthrough new treatment for C. difficile infection (CDI) recurrence, which should get underway in 2022.
This follows November’s successful fundraiser, which brought in £10.4mln and the completion of the acquisition of the drug candidate, known as NTCD-M3.
Key among the early initiatives was the signing of a major new manufacturing contract that will deliver a more efficient process and a lower cost product.
This will be important as Destiny scales up for a final-stage clinical assessment of 800 patients required by the US Food & Drug Administration.
The company has also brought in high-level expertise in the form of Professor Dale Gerding, who has joined the drug developer’s scientific advisory board as well as becoming a “key consultant”.
“His world-leading expertise in C. difficile infections and many years of research and clinical work on NTCD-M3, will be invaluable and he is an important addition to our team,” Destiny said.
In the same statement, the company said it was starting efforts to find commercial partners and grant funding bodies “to raise awareness of the re-activated NTCD-M3 clinical programme”.
In the US, there are around 500,000 cases of CDI a year with a recurrence rate of 25%, which leads to around 29,000 deaths annually.
Treatment options are limited with lower efficacy observed when patients are re-treated with the same antibiotics following the return of the infection.
The extra costs of care, meanwhile, range from $10,000-$20,000 per patient and the total annual CDI-attributable cost in the US alone is estimated to be around US$6.3bn.