Mission Therapeutics gets FDA approval to continue trial with new AKI drug
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Key takeaways:
- Mission Therapeutics received FDA approval to initiate a phase 2 trial for MTX652.
- Up to 160 adults with increased risk for AKI following cardiac surgery are being recruited for the trial.
Mission Therapeutics has received FDA approval to initiate a phase 2 clinical trial for its drug MTX652 to treat AKI after cardiac surgery, according to a press release.
The company said approval to continue the trial came after the FDA approved its investigational new drug application trial for MTX652 in treating AKI.
The phase 2 trial is expected to begin in the early part of 2024 and will include up to 160 patients with AKI following cardiac surgery, according to the release.
“Recent reports suggest that up to 50% of high-risk patients suffer acute kidney injury following heart surgery,” Suhail Nurbhai, MBCHB, MRCP(UK), chief medical officer of Mission Therapeutics, said in the release. “There are no approved drug treatments and the immediate and longer-term consequences can be serious, including continued decline of renal function and/or the requirement for renal replacement therapy.
“We believe MTX652 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,” Nurbhai said in the release.
Paul Thompson, PhD, chief scientific officer of the company, said in the release that MTX652 demonstrated “significant protective effects” in multiple models of kidney injury, and “this breadth of effect is encouraging in indicating potential clinical benefit.”
The double-blind, placebo-controlled trial will take place at multiple sites in North America and Europe. “The trial is expected to begin early 2024 and is intended to show that MTX652 protects this high-risk group of patients from AKI by assessing standard markers of renal function and renal injury over time,” according to the release.
The company said MTX652 is designed to improve mitochondrial quality and function by enhancing mitophagy through inhibition of USP30, a deubiquitylating enzyme localized to mitochondria which is a negative regulator of mitophagy.
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