- Phase 2a MAINSAIL Trial of NAV-240 in Hidradenitis Suppurativa (HS) Recruiting Ahead of Schedule
- Early Cohorts in Phase 1 Study of Next-Generation Subcutaneous Bispecific Antibody NAV-242 Indicate Extended Half Life (HLE) on Path to Goal of Delivering Best in Disease Efficacy, and Preferred Patient-Friendly Dosing in HS
- Navigator Presents New Emerging Data Across NAV-240 and NAV-242 Development Program
- Late-Breaking Data on Spatial Mapping of HS Skin Shows TNFα and OX40L Localized Near Draining Tunnels
SAN MATEO, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Navigator Medicines Inc., a clinical-stage biotech company pioneering best-in-class bispecific antibodies (bsAb) for inflammatory disorders and autoimmune diseases in areas of high unmet need, today announced rapid progress and new data from across its bsAb development program. New data will be presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026, in Vienna, Austria expanding the growing body of evidence that dual inhibition of TNFα and OX40L has the potential to raise the bar in the treatment of Hidradenitis Suppurativa (HS).
Emerging data characterizing the location of TNFα and OX40L at the sites of HS draining tunnels will also be presented by Associate Professor Johannes Griss, from the Medical University of Vienna, during a late-breaking session at the conference, further indicating a role for TNFα and OX40L as key drivers of inflammation in HS tunnel development.
“The Phase 2a MAINSAIL trial of our TNFα and OX40L bispecific NAV-240, is enrolling ahead of schedule, reflecting the significant need for new treatments in HS and growing anticipation for bispecific treatment approaches. At EADV, we’re sharing Phase 1 data for NAV-240, demonstrating a favorable safety profile, while preserving T-cell functionality,” said Tosh Butt, Chief Executive Officer, Navigator Medicines. “We are also advancing NAV-242, a half-life extended TNFα and OX40L bispecific antibody with potential for differentiated dosing. Its Phase 1 study is underway and already showing promising data in early cohorts with full data expected in H2 2027.”
NAV-240 Development in HS Progressing Ahead of Schedule
MAINSAIL, is a multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of NAV-240 in adults living with moderate to severe HS. Efficacy including a reduction in abscesses, nodules, draining tunnels, as well as improvement in quality-of-life outcomes will be assessed. The program is recruiting patients ahead of schedule, reflecting the need for novel therapies in HS. Results are expected in Q3 2027 to inform future development of both NAV-240 and NAV-242. Full details of the Phase 2a MAINSAIL trial can be accessed at www.clinicaltrials.gov (NCT07384975).
New Insights on NAV-242, a Next-Generation, Half-Life Extended Bispecific Antibody
Early cohorts in the Phase 1a/b study of Navigator’s next-generation subcutaneous therapeutic, NAV-242 have confirmed an extended half-life. The study assesses safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity through single and multiple ascending doses (SAD and MAD) in healthy participants, with full study results expected in H2 2027.
At EADV Congress, Navigator Presents Emerging Data For NAV-240 and NAV-242 Development Program
New translational data from the Phase 1 SAD and MAD studies of NAV-240 (Poster P1749) to be presented at EADV 2026, assess the safety, tolerability, PK, PD and immunogenicity of NAV-240 after repeat dosing in 64 healthy volunteers at various doses. NAV-240 demonstrated an acceptable safety and tolerability profile with results consistent with the dual-targeting mechanism, low immunogenicity and retention of anti-viral T-cell functionality needed for long-term immune health.
Pre-clinical data to be presented for NAV-242 (Poster P1782) show enhanced stability and extended PK in vivo compared with NAV-240, further supporting the potential for extended subcutaneous dosing of NAV-242.
Late-Breaking Data on the Role of TNFα and OX40L in Draining Tunnel Lesions
(D2T01.4B, Thursday, October 1, 16:30-16:45 CEST)
Emerging data from skin sections collected from patients living with HS demonstrates that spatially TNFα and OX40L were both found close to tunnel-associated cells suggesting they both play important roles in HS pathology. This research was conducted by Johannes Griss, from the Medical University of Vienna with support from Navigator Medicines, and presented during a late-breaking session. These data suggest that bsAb that can act on both TNFα and OX40L, like Navigator’s NAV-240 and NAV-242 program, could reduce inflammation with specificity at the site of tunnel development. In more advanced HS disease, draining tunnels, also known as sinus tracts or fistulas, can form under the skin connecting lesions and leaking fluid and pus, leading to pain, scarring and a heavier daily disease burden for patients.1
“Understanding where the immune response is happening in hidradenitis suppurativa is important for developing better treatments. These new data show that TNFα and OX40L are concentrated at draining tunnel sites, which indicates they act together to sustain inflammation. These findings support further exploration of treatments like NAV-240 and NAV-242 that can target both drivers of inflammation,” said Associate Professor Griss, Medical University of Vienna.
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease, characterized by painful, recurrent abscesses and lesions. People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.
HS affects three times more women than men, with global prevalence estimates2 of ~1% of the population based upon a meta-analysis of 25 trials across 23 countries, with recognized regional variability. Over one million people in the U.S. live with moderate-to-severe HS, with only 350,000 currently seeking treatment. Given the magnitude of disease burden and the potential introduction of several new biologics in the coming years, the opportunity to help people living with HS is projected to increase significantly over the next 5 years.
About Navigator Medicines
At Navigator Medicines, our mission is to bring new hope to people facing inflammatory disorders and autoimmune disease with high unmet needs. We advance best-in-class bispecific antibodies to address the daily challenge of chronic inflammation. Navigator Medicines was founded in 2024 as a subsidiary of Sera Medicines. To learn more visit www.navigatormedicines.com
Contacts:
Business or Investor Inquiries:
Mark McLaughlin
mmclaughlin@navigatormeds.com
Media Inquiries:
Arran Attridge
arran.attridge@navigatormeds.com
References
1. Krajewski PK, Szepietowski JC, Martorell A. Tunnels in hidradenitis suppurativa: active inflammatory entities with specific molecular and genetic profiles: a narrative review. Dermatology. 2023;239(3):323-327. doi:10.1159/000529848
2. Bouazzi D, Nielsen SM, Hagan PG, et al. Prevalence of Hidradenitis Suppurativa: A Meta-Analysis of Global Hidradenitis Suppurativa Atlas Studies. JAMA Dermatol. Published online August 27, 2025. doi:10.1001/jamadermatol.2025.2373
