Navigator Medicines Advances Bispecific Antibody Programs for Hidradenitis Suppurativa

Got story updates? Submit your updates here. ›

Navigator Medicines, a clinical-stage biotech company, has announced the initiation of a Phase 2a trial for its bispecific antibody NAV-240 in the treatment of hidradenitis suppurativa (HS). The company has also entered Phase 1 clinical development for its next-generation half-life extended bispecific antibody, NAV-242. This progress follows positive results presented at the American Academy of Dermatology Congress 2026.

Why it matters

HS is a chronic, painful skin condition that affects over 1 million people in the U.S., with only a fraction currently seeking treatment. Navigator's bispecific antibody programs targeting OX40 ligand and TNFα have the potential to significantly improve outcomes for those living with HS, a disease with high unmet medical needs.

The details

The Phase 2a MAINSAIL trial will assess the efficacy and safety of NAV-240 in adults with moderate to severe HS. Results are expected in the second half of 2027. Navigator also presented positive data from a Phase 1b multiple ascending dose study of NAV-240, which demonstrated a favorable safety and tolerability profile, predictable pharmacokinetics, and low rates of immunogenicity. Additionally, the company has initiated a Phase 1 study of its next-generation half-life extended bispecific antibody, NAV-242, which offers the potential for less frequent subcutaneous dosing.

• The Phase 2a MAINSAIL trial of NAV-240 has begun patient dosing.
• Results from the Phase 1a portion of the NAV-242 study are expected in Q4 2026.

What they’re saying

What’s next

Results from the Phase 2a MAINSAIL trial of NAV-240 are expected in the second half of 2027, which will inform future development of both NAV-240 and NAV-242.