Allay Therapeutics Raises $60 Million to Finance its Non-Opioid Pain Management Platform

On September 15th, California-based Allay Therapeutics announced securing $60 million in an oversubscribed Series C financing. The money will be used to fund the Phase 2b clinical trial of its most advanced therapeutic, ATX-101, in the US and support the advancement of its pipeline, the company said.

Allay’s goal is to advance at least one candidate to clinical trials every year, and they intend to increase manufacturing capabilities in California to support product launches.

The latest round of funding brings the total amount of money raised to $92 million. The Series C was led by Arboretum Ventures with participation from NEA, Temasek, Pavilion Capital, Brandon Capital Partners, Vertex Growth, Vertex Ventures HC, and WTT Investment Ltd.

“Demand for total knee replacement surgery is growing dramatically, and with it, desire for non-opioid solutions providing lasting pain relief. We believe that Allay’s technology platform offers unprecedented potential breadth in terms of applicability and therapeutic profile for pain management, an area in need of innovation,” said Nicole J. Walker, Managing Partner, Arboretum Ventures.

Non-Opioid Pain Relief

The number of total knee replacement surgeries is projected to grow by almost 700% to 3.5 million surgeries per year by 2030. At the same time, the opioid crisis has created a need for long-lasting, non-addictive, and non-opioid-based pain management treatments. 

Medications such as localized analgesics such as Zynrelef from Heron Therapeutics provide an alternative for pain management; however, this type of post-surgical analgesics has a demonstrated short effectiveness of only three days. Additionally, they often need to be supplemented with opioids to manage pain. Therefore, there is a need for better therapeutics to support optimal recovery for patients. 

Ally Therapeutics has developed a non-opioid pain relief technology that lasts up to two weeks with a single administration.

“Pain management innovation has stalled for too long in the face of the enormous need created by the opioid crisis and a growing number of patients undergoing painful surgeries where rapid recuperation is crucial for long-term outcomes…” Adam Gridley, CEO of Allay Therapeutics, summarized the unmet need of patients in a press statement last May.

ATX-101 for Pain Management

Allay specializes in developing ultra-sustained non-opioid-based analgesics to help with pain management post-surgery. Their proprietary technology combines bupivacaine, a local non-opioid anesthetic, with naturally degradable polymers. 

ATX-101 is a small dissolvable product, which is placed inside the surgical site following total knee replacement. The implant continuously releases analgesics for weeks. The amount of drugs released decreases over time to match the level for pain relief, the highest dose is released immediately after surgery when the levels of pain are greatest, and the levels decrease over time. 

A Phase 1b/2a clinical trial showed that ATX-101 reduced the number of opioids patients took for pain management, it outperformed the standard of care for both duration and magnitude of the effect as measured using proprietary data sets of pain scores, it delivered predictable doses, and it was well-tolerated.

Additionally, Allay is working on developing new formulations, injectables, and new formulations that incorporate a variety of small molecules and other analgesics. All of which are in preclinical development.

Author

Daniel Ojeda