Allay Therapeutics has dosed the first subject in the randomised Phase IIb registration trial of its investigational analgesic, ATX101, designed to provide extended pain relief following total knee replacement surgery.
The therapy aims to minimise opioid requirements and enhance patient recovery outcomes.
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Involving 200 subjects undergoing total knee arthroplasty (TKA), the three-arm, controlled trial is being conducted across several sites in the US.
It compares a 1,500mg dosage of the therapy with a placebo and bupivacaine active comparator.
Allay Therapeutics chief medical officer David Hewitt said: “We’re thrilled to achieve this important milestone with the patients dosed in our Phase IIb registration trial of ATX101.
“This trial is a significant step forward on our path to changing the paradigm of postoperative pain management by providing a simplified locally targeted solution that provides sustained analgesia in the weeks following surgeries.”
A previous Phase IIb dose-ranging trial demonstrated the therapy’s potential to decrease pain and opioid use while improving functional activities for up to 60 days post-surgery.
In Japan, the company’s partner Maruishi Pharmaceutical has also dosed the first participant in an open-label, multi-centre Phase I/II safety trial of the therapy.
Initial outcomes from both trials are expected in the second half of this year.
ATX101, which combines bupivacaine with a biopolymer, is designed to provide weeks of pain relief and is easily administered during standard knee replacement surgery.
Its “high” drug density allows for prolonged analgesic effects, eventually dissolving into carbon dioxide and water.
The application of the therapy is straightforward and does not require any training. It is designed to simplify the current complex analgesic regimen for post-surgical pain management.
However, ATX101 is yet to receive approval from the US Food and Drug Administration.
