NBL-012 monoclonal antibody targeting il23p19 for chronic skin inflammatory diseases
NBL-012 is a novel monoclonal antibody that inhibits IL23p19 binding to IL23R, addressing chronic skin inflammatory conditions such as psoriasis and hidradenitis suppurativa. Phase I results demonstrate an extended half-life of 32-34 days and superior drug exposure, supporting potential six-month dosing intervals and reduced treatment burden.
Overview
NBL-012 is a novel monoclonal antibody developed to treat chronic skin inflammatory diseases by targeting the IL23/IL17 pathway, which plays a critical role in over four hundred conditions, including psoriasis and hidradenitis suppurativa. The antibody works by inhibiting the binding of IL23p19 to its receptor IL23R, interrupting the inflammatory cascade at a well-validated point of intervention. In a Phase I clinical study conducted in healthy volunteers, NBL-012 demonstrated a half-life of 32 to 34 days and achieved drug exposure levels significantly higher than four currently marketed IL23p19 antibody drugs. Clinical pharmacology modeling suggests the potential for extended dosing intervals of up to six months, which could substantially reduce treatment burden for patients with chronic conditions requiring long-term management.
Technical specifications
Key features:
- Mechanism of action: Neutralizes IL23p19, blocking its interaction with IL23R and downstream IL23/IL17 signaling
- Extended half-life: 32 to 34 days in healthy volunteers, surpassing existing marketed IL23p19 antibodies
- Superior drug exposure: Higher area under the curve (AUC) compared to four currently approved competitor antibodies
- Potential dosing flexibility: Clinical pharmacology modeling supports dosing intervals of up to six months between administrations
- Safety profile: Demonstrated safety in Phase I clinical trial with healthy volunteers
- Target indications: Chronic skin inflammatory diseases, with initial focus on psoriasis and hidradenitis suppurativa
Technology readiness level
NBL-012 has completed a Phase I clinical trial in healthy volunteers, where it demonstrated a favorable safety profile, an extended half-life of 32 to 34 days, and superior drug exposure relative to existing IL23p19 antibody therapies. Based on these results, the candidate is ready to advance into a Phase II clinical study in psoriasis patients to evaluate efficacy and further validate the potential for six-month treatment intervals. The program is supported by an active IND and is positioned for partnership as it transitions into patient-based efficacy trials.
About Novarock biotherapeutics
NovaRock Biotherapeutics is a clinical-stage biotechnology company that specializes in the discovery and development of innovative antibody therapies for cancer and autoimmune diseases. Founded in 2018 by veteran scientists, the company focuses on advancing biologics from initial discovery through to commercialization. Their platform utilizes proprietary antibody engineering to create targeted therapeutic solutions, with a pipeline that includes candidates such as NBL-012, NBL-015, NBL-020, and NBL-028, which are designed to address various solid tumors and inflammatory conditions.
By targeting specific markers like Claudin-18.2 and Claudin-6, NovaRock seeks to provide safer and more effective treatment options for patients with significant unmet medical needs. The company actively advances its clinical programs through FDA-cleared investigational new drug (IND) applications and has established strategic partnerships and licensing agreements to expand the development and commercialization of its therapeutic candidates in international markets. These efforts are supported by clinical trials focused on evaluating the safety, pharmacokinetics, and efficacy of their candidates in patients with advanced malignant tumors.
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