(Sharecast News) - Clinical-stage biotechnology company Destiny Pharma announced a cooperative research and development agreement with the US Department of Veterans' Affairs on Tuesday, to support studies focusing on identifying new attributes for 'NTCD-M3' - a novel microbiome therapeutic being developed to reduce the recurrence of Clostridioides difficile infections in the gut.
The AIM-traded firm said it would collaborate on the research project with the Edward Hines Jr. VA Hospital in Hines, Illinois, usine its C. difficile research expertise to complete new preclinical studies that could support the administration of NTCD-M3 to a broader patient population, and thus strengthen the market opportunity.
It said the research project was planned to complete in the fourth quarter of 2021, with financial terms not disclosed.
Stuart Johnson, MD Professor of Medicine at the Loyola Stritch School of Medicine, would lead the team conducting further studies of NTCD-M3 at the Edward Hines, Jr. VA Hospital, which Destiny said was recognised for its "advanced research" into the diagnosis, epidemiology, prevention and treatment of C. difficile infection.
C. difficile infection is the leading cause of hospital-acquired infection in the United States, with current treatments leading to significant recurrence.
In the US, there were around 500,000 cases of infection each year, with many of those initial cases then recurring, leading to 29,000 deaths per year.
The company said NTCD-M3 had the potential to become the leading treatment for C. difficile infection prevention, as its phase 2 data demonstrated a "class-leading" 5% rate of recurrence, compared to 30% with placebo.
Destiny Pharma said it was progressing its plans for a single phase 3 clinical study, the design of which had already been discussed with the US Food and Drug Administration (FDA), which needed to be completed before submitting marketing authorisation applications in the US and Europe.
The phase 3 clinical study remained on schedule to start in 2022, the board said.
Destiny Pharma said it had also started discussions with potential licensing partners and collaborators, adding that it was "encouraged" by the level of interest in the programme.
The aim was to secure a partner to support the planned phase 3 clinical study, and participate in the future commercial launch of NTCD-M3.
"We are very pleased to be working with the expert C. difficile infection team at the Edward Hines, Jr. VA Hospital in Chicago," said chief executive officer Neil Clark.
"The planned study will help Destiny Pharma refine our planning for the NTCD-M3 phase 3 study that we aim to start in 2022.
"There is a significant clinical and commercial opportunity for NTCD-M3 as a novel treatment to prevent the recurrence of C. difficile infection."
At 0927 BST, shares in Destiny Pharma were down 1.59% at 136.3p.
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