Allay Therapeutics has exited stealth armed with clinical pain data, cash from backers including NEA and plans to move its lead candidate into phase 2b this year.
The lead candidate, ATX-101, consists of the well-established intracellular sodium ion channel blocker bupivacaine and a bioresorbable polymer. When implanted during total knee replacement surgery, the candidate is designed to release half of the suspended bupivacaine over the first few days to allay breakthrough pain and then issue less and less of the painkiller as the patient recovers.
Allay now has clinical data from a 22-patient phase 1b/2a trial to back up its belief in the approach. In describing the data, Allay focused on the patients who received 1,500 mg of ATX-101, the highest dose used in the trial.
While the trial lacked a control arm, Allay calculated patients on 1,500 mg of ATX-101 used “between half to two-thirds less opioids than a typical [total knee arthroplasty] patient.” Eighty percent of the patients were off opioids by Day 14. Based on the published literature, Allay would expect half of people treated with standard of care to be off opioids by that time.
Allay also said ATX-101 significantly outperformed standard of care in terms of the duration and magnitude of effect. However, the statement lacks the numbers and is again based on comparison to historical controls.
Armed with the data, Allay is now planning more rigorous tests of the performance of ATX-101. The biotech plans to start a phase 2b study this year with a view to being in a position to file for approval from the FDA in 2024.
Allay has reached this point with the support of The Foundry incubator and Lightstone Ventures’ Singapore fund, which founded it in 2017, as well as investors that participated in the NEA-led $25 million series B in 2019. Between those two events, Allay bought Orchid Medical for its polymer technology.
The bioresorbable polymer is central to Allay’s strategy. Using the polymer, Allay plans to tailor the local release of validated painkillers to the pain trajectories of different patient populations and, in doing so, reduce the need for systemic opioids.