[Edaily Reporter NA EUN-KYUNG ] Inventage Lab Inc.(389470)has received the final clinical study report (CSR) for the Phase 1 clinical trial in Australia of “IVL3004,” a once-monthly drug addiction treatment. Based on results showing a reduction in initial drug over-release and a shorter duration of injection site reactions compared to existing treatments, the company plans to proceed with clinical trials in the U.S. and pursue global technology transfer.

Inventage Lab Inc. announced on the 2nd that it had received the Clinical Study Report (CSR) for the Australian Phase 1 clinical trial of IVL3004, a long-acting treatment for alcohol and opioid dependence. This report includes safety, tolerability, and pharmacokinetic (PK) analysis results observed across various dose groups.

IVL3004 is a naltrexone formulation developed using Inventage Lab Inc.’s microfluidic-based long-acting injectable platform, “IVL-DrugFluidic.” Naltrexone is a compound that binds to opioid receptors in the brain to block the effects of opioid drugs; it is used to treat alcohol dependence and to prevent relapse in opioid-dependent patients who have completed detoxification.

“Vivitrol,” the comparator for IVL3004, is also a once-monthly intramuscular injection containing naltrexone. It is used in the United States to treat alcohol dependence and opioid dependence, with a 380 mg dose administered every four weeks. Inventage Lab Inc. is developing an improved new drug that uses the same active ingredient while enhancing the rate of drug release and tolerability at the injection site.

Inventage Lab Inc. received approval for its Phase 1 clinical trial plan for IVL3004 in Australia in January 2023 and released topline data—the key results—last September. The company has now completed the analysis of all dose groups and secured the final Clinical Study Report (CSR).

In the clinical trial, healthy adult Namsangs received single intramuscular injections of 300 mg and 380 mg of IVL3004, respectively, and the drug was exploratively compared with 380 mg of Vivitrol in terms of pharmacokinetics, safety, and tolerability.

Pharmacokinetic evaluation results showed that IVL3004 demonstrated sustained drug exposure for four weeks following administration at both doses. Notably, in the 380 mg dose group—which matched the dose of Vivitrol—the total drug exposure (AUC) was similar, while the phenomenon of rapid drug release immediately after administration was suppressed.

Initial over-release refers to the phenomenon where an excessive amount of drug is released within a short period immediately after administration of a long-acting injectable formulation. Since a rapid increase in blood drug concentration can heighten the risk of adverse reactions, controlling the drug to release at a constant rate is considered a core technology in the development of long-acting formulations.

Even in the group administered 300 mg of IVL3004—a dose approximately 21% lower than that of Vivitrol—blood drug concentrations remained above the company’s target therapeutic level for four weeks. Inventage Lab Inc. explained that this confirmed the potential to develop an improved new drug that maintains drug exposure with a lower dose than existing products.

In safety and tolerability evaluations, IVL3004 exhibited a profile of adverse reactions that was generally similar to that of Vivitrol. In particular, the average duration of injection site reactions (ISRs) for IVL3004 was 4.3 days, approximately 75% shorter than the 17.2 days observed with Vivitrol. Injection site reactions are local adverse reactions—such as pain, swelling, and redness—that may occur following administration of long-acting intramuscular injections. Since injection site reactions are also a key safety monitoring parameter for Vivitrol, Inventage Lab Inc. expects these results to serve as a differentiating factor for IVL3004 in terms of tolerability.

However, this clinical trial was a single-dose study conducted in healthy adults. The results confirm the drug’s exposure profile and tolerability but do not demonstrate therapeutic efficacy in patients with alcohol or opioid dependence, nor do they prove clinical superiority over existing products.

Based on this CSR, Inventage Lab Inc. plans to pursue follow-up development and expand indications. Even with the same naltrexone active ingredient, the required dosage and drug exposure levels may vary depending on the target indication; therefore, the company plans to utilize the results from the low-dose administration in the development of additional indications.

The company is also accelerating its efforts to secure patents in the United States. Following a U.S. patent protecting the composition and particle characteristics of naltrexone microparticles, the company received a decision in September to grant an additional U.S. patent for a “sustained-release injectable composition containing naltrexone and a method for its manufacture.”

The company has also secured government R&D funding. The IVL3004 development project was selected in August for the “2026 Policy-Designated Global TIPS” program and will receive R&D funding of 6 billion won over a maximum of four years.

An Inventage Lab Inc. official stated, “Based on the CSR we have secured, we plan to discuss follow-up development plans with the U.S. Food and Drug Administration (FDA) and proceed with the global Phase 2 clinical trial for IVL3004.” The official added, “Since we have confirmed the unique advantages of our platform-based product compared to the marketed drug Vivitrol, we will intensify discussions on technology transfer and joint development with pharmaceutical companies that possess expertise in this therapeutic area.”