SCOTCH PLAINS, NJ. — November 20, 2025 — Leads & Copy — Navigator Medicines Inc. has successfully completed participant visits in the Phase 1b multiple-ascending dose study (MAD) of NAV-240. Results from the full study are expected in Q1 2026, with further clinical development of NAV-240 in hidradenitis suppurativa slated to begin in early 2026.
The Phase 1b trial assessed the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of NAV-240 after repeat doses in 24 healthy volunteers. Navigator plans to share the study’s results in the first quarter of 2026, which will inform the clinical path for NAV-240 and NAV-242. These two bispecific antibodies are the most advanced in Navigator’s anti-OX40L and anti-TNFα bispecific antibody development program.
NAV-240 targets both OX40L and TNFα, two clinically-validated targets that drive complex inflammatory disorders, including hidradenitis suppurativa (HS). The Phase 1b MAD study builds on the positive safety and tolerability profile demonstrated in the Phase 1a single ascending dose (SAD) study presented earlier this year.
According to Dr. Dana McClintock, Chief Medical Officer of Navigator Medicines, achieving Last Patient Last Visit (LPLV) in the Phase 1b MAD study is an exciting step forward in the company’s mission to unlock the potential of OX40L and TNFα dual inhibition and raise the efficacy bar for hidradenitis suppurativa treatment. The company is advancing NAV-240 at pace and is on track to share Phase 1b results in Q1 2026 and proceed with NAV-240 Phase 2 evaluation in HS.
Navigator Medicines is developing a portfolio of best-in-class treatments for inflammatory and autoimmune diseases, focusing on OX40L combination approaches. The company’s next-generation candidate, NAV-242, builds on the positive profile of NAV-240. This bispecific antibody, targeting OX40L and TNFα, is engineered for extended half-life, offering optimized exposure and a convenient dosing schedule with the potential to be best-in-class. If approved, NAV-242 could offer a differentiated treatment for conditions like hidradenitis suppurativa, Crohn’s disease, and ulcerative colitis.
NAV-240 is a clinical-stage bispecific antibody targeting OX40L and TNFα, which are critical in the pathogenesis of difficult-to-treat inflammatory diseases. Dual targeting of OX40L and TNFα-driven signaling pathways may improve the efficacy of either monotherapy alone as a potential treatment option for heterogeneous diseases with unmet medical needs.
NAV-242 is a preclinical bispecific antibody designed to simultaneously inhibit OX40L and TNFα. Navigator Medicines has engineered NAV-242 to extend its half-life and enable optimized dosing, offering a potentially differentiated and convenient treatment option for people living with complex inflammatory disorders and autoimmune diseases such as hidradenitis suppurativa, Crohn’s disease, and ulcerative colitis.
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by painful, recurrent abscesses and lesions. Individuals with HS experience flare-ups of the disease and severe pain, which can significantly impact their quality of life.
HS affects three times more women than men, with prevalence estimates reaching as high as 4% in the U.S. Over one million people in the U.S. live with moderate-to-severe HS, but only 350,000 are currently seeking treatment. The opportunity to assist individuals with HS is projected to increase significantly over the next five years, given the magnitude of disease burden and the potential introduction of new biologics.
Navigator Medicines aims to bring new hope to people facing inflammatory disorders and autoimmune disease with high unmet needs, advancing best-in-class bispecific antibodies to address the daily challenges of chronic inflammation. Founded in 2024 as a subsidiary of Sera Medicines, Navigator Medicines is supported by a $100 million Series A financing, co-led by RA Capital Management and Forbion.
Business or Investor Inquiries:
Mark McLaughlin
info@navigatormedicines.com
Media Inquiries:
Arran Attridge
arran@attridgecomms.com
Source: Navigator Medicines Inc.
