Autonomix Medical, Inc. (NASDAQ: AMIX) announced plans to expand its innovative cancer pain management clinical trial to include additional cancer types beyond pancreatic cancer. The company's follow-on phase of its proof-of-concept trial, designated as "PoC 2," is scheduled to begin in the second quarter of 2025.
The expansion follows positive results from the initial phase of the company's first-in-human trial, which evaluated the safety and effectiveness of delivering transvascular energy to ablate problematic nerves and mitigate severe pain in pancreatic cancer patients.
"We are thrilled with the compelling results of our PoC 1 phase in late-stage pancreatic cancer patients, which demonstrated a significant reduction in pain, substantially decreased opioid use, and showed a meaningful improvement in quality of life for these patients," said Brad Hauser, CEO of Autonomix. "Building on this success, we are expanding our investigation to include gall bladder, liver, and bile duct cancers—effectively doubling our addressable potential market."
Expanding the Treatment Landscape
The follow-on study will evaluate additional visceral cancers that signal pain through the Celiac Plexus, as well as earlier stage pancreatic cancers with moderate to severe pain. This strategic expansion aims to address a significant unmet need in cancer pain management.
Cancer pain, particularly in abdominal malignancies, remains a challenging aspect of patient care. Current treatment options often rely heavily on opioid medications, which can lead to side effects and diminished quality of life. Autonomix's approach offers a potential alternative by directly targeting the nerves responsible for transmitting pain signals.
Innovative Technology Platform
At the core of Autonomix's approach is a proprietary catheter-based microchip sensing array that can detect and differentiate neural signals with greater sensitivity than currently available technologies. This platform enables transvascular diagnosis and treatment of diseases involving the peripheral nervous system.
The technology constitutes a platform with potential applications across dozens of indications, including cardiology, hypertension, and chronic pain management. However, the PoC 2 phase will maintain a concentrated focus on interventional cancer pain management applications.
Market Impact and Future Directions
The expansion into additional cancer types represents a significant market opportunity for Autonomix. Pancreatic cancer affects approximately 60,000 Americans annually, with pain management being a critical component of care. By including gallbladder, liver, and bile duct cancers, the company aims to double its addressable market.
The technology's potential extends beyond oncology pain management. Autonomix has indicated interest in further expansion into other areas of oncology, gastroenterology, and additional sectors where the company has established relationships with key opinion leaders and has emerging preclinical evidence.
Clinical Trial Details
The PoC 2 phase will build upon the methodology established in the initial trial. The company's approach involves a minimally invasive procedure to deliver targeted energy to specific nerve pathways, potentially offering longer-lasting pain relief with fewer systemic side effects compared to conventional pharmacological approaches.
While specific enrollment targets have not been disclosed, the trial is expected to include patients with various visceral cancers experiencing moderate to severe pain. The primary endpoints will likely focus on pain reduction, quality of life improvements, and decreased reliance on opioid medications.
Regulatory Status
It's important to note that Autonomix's technology remains investigational and has not yet received marketing clearance from the U.S. Food and Drug Administration. The upcoming PoC 2 trial represents an important step in the company's clinical development program and regulatory pathway.
The company continues to advance its platform while maintaining compliance with regulatory requirements. Autonomix filed its Annual Report on Form 10-K with the U.S. Securities and Exchange Commission on May 31, 2024, providing detailed information about the company's operations and risk factors.
As Autonomix prepares for this next phase of clinical development, the medical community will be watching closely to see if the promising results from the initial trial can be replicated and expanded to benefit a broader population of cancer patients suffering from debilitating pain.
