SAN MATEO, Calif. — September 29, 2026
Navigator Medicines announced new clinical and translational data from its NAV-240 and NAV-242 bispecific antibody programs in hidradenitis suppurativa (HS) at the European Academy of Dermatology and Venereology Congress 2026 in Vienna. The company reported that its Phase 2a MAINSAIL trial of NAV-240, a bispecific antibody targeting TNFα and OX40L, is recruiting ahead of schedule in adults with moderate-to-severe HS. Navigator also presented early Phase 1 data for NAV-240 and reported that initial cohorts from the Phase 1a/b study of next-generation NAV-242, a half-life-extended subcutaneous TNFα/OX40L bispecific antibody, demonstrated an extended half-life. The company said full NAV-242 Phase 1 results are expected in the second half of 2027, while MAINSAIL results are expected in the third quarter of 2027.
NAV-240 Phase 2a MAINSAIL Trial Advances in HS
The randomized, double-blind, placebo-controlled Phase 2a MAINSAIL trial is evaluating NAV-240 in adults with moderate-to-severe hidradenitis suppurativa. The study is designed to assess efficacy and safety, including changes in abscesses, nodules and draining tunnels, as well as quality-of-life outcomes. Navigator reported that enrollment is progressing ahead of schedule, although the company has not yet disclosed comparative efficacy results from the trial. The program is intended to generate clinical evidence for dual inhibition of TNFα and OX40L, two inflammatory pathways being investigated as potential contributors to HS pathology. MAINSAIL is registered under NCT07384975, and results are expected in Q3 2027 to inform subsequent development of both NAV-240 and NAV-242.
NAV-242 Shows Extended Half-Life in Early Phase 1 Cohorts
Early cohorts in the Phase 1a/b study of NAV-242 have demonstrated an extended half-life, supporting Navigator’s development strategy for a potentially more convenient subcutaneous dosing profile. NAV-242 is a next-generation bispecific antibody designed to simultaneously inhibit TNFα and OX40L and incorporates a half-life-extension approach compared with NAV-240. The ongoing study is evaluating safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity through single-ascending-dose and multiple-ascending-dose cohorts in healthy participants. Navigator also presented preclinical findings showing enhanced stability and extended pharmacokinetics for NAV-242 compared with NAV-240 in vivo. However, the company said the complete Phase 1 dataset is expected in H2 2027, so the clinical significance of the early pharmacokinetic findings remains to be established.
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EADV Data Examine TNFα and OX40L in HS Draining Tunnels
Late-breaking research presented at EADV 2026 examined the spatial distribution of TNFα and OX40L in skin samples from patients with hidradenitis suppurativa. According to the findings reported by Navigator and Associate Professor Johannes Griss of the Medical University of Vienna, both inflammatory targets were localized near cells associated with draining tunnels in HS lesions. The researchers said the findings support further investigation of therapies capable of simultaneously targeting both pathways, including NAV-240 and NAV-242. Additional Phase 1 translational data for NAV-240, presented in healthy volunteers, included safety, tolerability, pharmacokinetic, pharmacodynamic and immunogenicity assessments following repeat dosing in 64 participants. Navigator reported an acceptable safety and tolerability profile, low immunogenicity and retention of antiviral T-cell functionality. These findings are early-stage and require confirmation in patients with HS and controlled clinical studies.
Source :Navigator Medicines press release
