Oct. 4, 2025 – 4B Technologies(4B) announced that its independently developed, first-in-class (FIC) monoclonal antibody drug, 4B03-04 injection which features a novel mechanism of action, has been approved for entering clinical trial by the US Food and Drug Administration (FDA).
The phase I clinical trial of 4B03-04 is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and efficacy of a single ascending dose (SAD) of 4B03-04 in patients with osteoarthritis pain. In parallel, a phase I SAD study of 4B03-04 in patients with osteoarthritis pain is ongoing in Australia, and enrollment for the third dose cohort has been completed.
Dr. Bai Lu, Founder of 4B，commented:
Chronic pain represents the third most significant global health burden, following cardio-cerebrovascular diseases and cancer. Currently, the therapeutic option often relies on opioid medications which carry high risks of addiction and side effects, leaving a substantial unmet need for novel, effective treatments for moderate to severe pain. Extensive basic research and human genetic data have demonstrated that the Nerve Growth Factor (NGF) is one of the keys signaling pathways in chronic pain. However, clinical trials of drugs designed to block NGF signaling have failed due to their associated side effects.
4B's investigational drug 4B03-04, an allosteric inhibitor of the NGF receptor, has demonstrated compelling analgesic efficacy in preclinical studies alongside an improved safety profile, potentially circumventing limitations of previous approaches. This promising candidate has the potential to become a breakthrough, non-addictive therapy, offering a new treatment paradigm for patients globally. We eagerly anticipate confirming its therapeutic profile in upcoming clinical trials to bring this much-needed option to patients promptly.
Dr. Ping Liu, CMO of 4B, said:
There is a pressing clinical need for non-opioid analgesics that are highly efficacious, safe, and convenient to administer. In early clinical studies, 4B03-04 demonstrated a favorable safety profile, predictable pharmacokinetics, and the potential for a monthly dosing regimen. We are now advancing the drug into confirmatory trials to expedite its development for patients with chronic pain.
About 4B03-04
4B03-04 is an innovative drug with global rights held by 4B Technologies. Unlike drugs targeting similar pathways, 4B03-04, via its unique and precise mechanism of modulating the TrkA receptor, effectively inhibits pain signal transduction without impeding the neurotrophic and other nociception-unrelated functions of NGF, thereby potentially minimizing side effects associated with broad NGF pathway disruptions.
In phase I SAD study of in healthy participants in Australia, 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.