FDA approves Mission Therapeutics’ phase 2 clinical trial for acute kidney injury treatment
Betsy Goodfellow | December 14, 2023 | News story | Medical Communications |Â Â FDA, Mission Therapeutics, Nephrology, acute kidney injury, clinical trialÂ
Mission Therapeutics has announced that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for MTX652, allowing the company to initiate its phase 2 clinical trial.
The trial aims to include up to 160 adult patients at an increased risk for Acute Kidney Injury (AKI) following cardiac surgery, and will take place at multiple sites across North America and Europe. It is expected that the double-blind, placebo-controlled trial will begin early in 2024 and will assess the extent to which MTX652 can prevent AKI in these patients by assessing standard markers of renal function and injury throughout the duration of the trial.
Dr Anker Lundemose, chief executive officer of Mission Therapeutics, commented: “The FDA’s approval of our phase 2 clinical study for our lead asset MTX652 marks a major milestone for Mission. We now have two USP30 inhibitors advancing through clinical trials, MTX652 for acute kidney injury and MTX325 for Parkinson’s Disease, validating our unique approach and the breadth of our assets.”
Dr Suhail Nurbhai, chief medical officer of Mission Therapeutics, added: “Recent reports suggest that up to 50% of high-risk patients suffer AKI following heart surgery. There are no approved drug treatments and the immediate and longer-term consequences can be very serious, including continued decline of renal function and/or the requirement for renal replacement therapy. We believe MTX562 has the potential to alleviate these outcomes and to meet this serious and important unmet medical need. We are delighted to have received this approval and look forward to starting this trial in 2024.”
Betsy Goodfellow
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