4B Technologies Limited (“4B Tech”), a neuroscience-focused biotech company, today announced topline results from its Phase 1 Single Ascending Dose (SAD) study of 4B03-04, an investigational humanized monoclonal antibody designed to treat chronic pain without opioid-related risks. The trial demonstrated a favorable safety profile, predictable pharmacokinetics, and a potential monthly dosing regimen, positioning 4B03-04 as a groundbreaking candidate in non-addictive pain management. 4B Tech will present Phase 1 SAD data from 4B03-04 at the upcoming 19th Annual Pain Therapeutics Summit in San Diego, California, USA.
In this randomized, double-blind, placebo-controlled study of healthy participants, 4B03-04 achieved the following key outcomes:
Strong Safety and Tolerability: Compared to drugs with a similar mode of action, 4B03-04 demonstrates superior tolerability with no observed dose-limiting toxicities at doses up to multi-fold higher than that estimated to achieve clinical efficacy.
No Significant Adverse Effects: No clinically meaningful neurological, autonomic, or systemic safety concerns were identified.
Linear Pharmacokinetics: 4B03-04 exhibited a dose-proportional pharmacokinetic profile up to the maximum tested dose, supporting predictable dosing.
Extended Half-Life: Data suggest a monthly (Q4W) dosing regimen, which enhances patient convenience and adherence.
“These results underscore the potential of 4B03-04 to transform the treatment landscape for chronic pain,” said Dr. Katie Su, MD/PhD, CEO of 4B Technologies. “The favorable safety profile at doses exceeding therapeutic thresholds, combined with patient-friendly dosing regimen, highlights 4B03-04’s promise as a safer alternative to opioids. We are accelerating development to address this critical unmet need.”
Building on these encouraging results, 4B Technologies has initiated trials in patients with osteoarthritis pain to obtain efficacy data, with plans to advance into Phase 2 studies in broader chronic pain patients.
About Chronic Pain
Chronic pain currently affects over 20% of the global population, ranking as the third most significant health issue following cardiovascular diseases and cancer. It severely impacts quality of life and imposes a substantial treatment burden. The global chronic pain drug market was valued at 80 billion USD in 2020 and is projected to reach 162 billion USD by 2030. While opioids provide potent pain relief, their severe side effects and addiction risks highlight the urgent need for safer, non-opioid alternatives.
About 4B03-04
4B03-04 is a humanized monoclonal antibody that uniquely addresses chronic pain by selectively inhibiting pain signaling through allosteric modulation of TrkA receptors. Unlike drugs targeting similar pathways, 4B03-04 achieves its analgesic effect without impeding the neurotrophic and other nociception-unrelated functions of nerve growth factor (NGF), thereby reducing side effects associated with broad NGF pathway disruptions. Preclinical studies indicate robust efficacy in pain models without interaction with opioid pathways, offering a potential replacement for opioid-based therapies in chronic pain management.