US-based biotech Allay Therapeutics has closed a $57.5 million Series D round co-led by ClavystBio, a life sciences venture builder established by Temasek, and biotech venture capital firm Lightstone Ventures.
The firm will use the proceeds to fund clinical trials of its next-generation analgesic for post-surgical pain and recovery.
The round saw participation by existing investors NEA, Arboretum Ventures, Vertex Growth, Vertex Ventures Healthcare, and Brandon Capital.
IPD Capital, EDBI and SGInnovate, and HSBC Innovation Banking also joined the round as new investors.
The proceeds will fund the Phase 2b registration trial for its lead asset ATX101, designed to offer long-lasting pain relief after total knee replacement and reduce reliance on opioids.
The trial started in February this year with 200 patients who had total knee replacement surgery. The study compares Allay’s drug ATX101 to a placebo and a commonly used pain medication called bupivacaine.
The drug received a breakthrough therapy designation from the FDA after earlier trials showed the drug eased pain for up to four weeks and improved patients’ mobility for up to two months following surgery.
The company expects to release results from its ongoing trial by the end of 2025. A Phase 3 trial is expected in 2026.
Japan’s Maruishi Pharmaceutical, which holds rights to ATX101 in Japan, has expanded its licensing territory to include South Korea and Taiwan, and has made an additional equity investment as part of the Series D. Maruishi is also conducting a Phase I/II study of ATX101 in Japan.
Allay has appointed veteran pharma executive Joe Zakrzewski as chairman of its board, while Anselm Tan, representing ClavystBio, will also take a board seat.