• Positive safety and tolerability profile of NAV-240 in Phase 1a study support further development
• Phase 1b study fully enrolled and data expected in early 2026
• Further clinical development of NAV-240 to begin in early 2026
  

SCOTCH PLAINS, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Navigator Medicines Inc., a clinical-stage biotech company pioneering the advancement of best-in-class bispecific antibodies for inflammatory disorders and autoimmune diseases in areas of high unmet need, today announced further data from a Phase 1a double-blind, placebo-controlled, single ascending dose (SAD) study of its lead therapeutic candidate, NAV-240.

In this Phase 1a study of 40 healthy volunteers, NAV-240 demonstrated a good safety and tolerability profile across dose cohorts. All participants remained in the study with no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) leading to discontinuation. The concentration of NAV-240 in the bloodstream increased in proportion to the dose over a range from 0.1 to 10 mg/kg, a key finding to support predictable dosing in further development. Concentration-dependent reductions were noted in thymus and activation-regulated chemokine (TARC), a signaling protein associated with several inflammatory skin conditions.

“By targeting both OX40L and TNFα we aim to deliver a synergistic and more durable response to unlock potential benefits for patients well beyond TNFα therapy alone, which remains the most widely used treatment for inflammatory conditions,” said Tosh Butt, Chief Executive Officer of Navigator Medicines. “These data provide a strong foundation for the continued clinical development of NAV-240, as an important part of our OX-40L/TNFα bispecific program of potentially best-in-class therapies for complex inflammatory disorders like hidradenitis suppurativa (HS), a debilitating inflammatory skin disease with a significant need for new treatment options.”

NAV-240 is a bispecific antibody designed to inhibit overactivation of the immune system and inflammation by blocking OX40L and TNFα. It is currently being investigated in an ongoing Phase 1b multiple ascending dose (MAD) study in healthy volunteers, which has now completed enrollment. Full results from this study will be available in early 2026.

Navigator Medicines is also advancing NAV-242, a next-generation engineered anti-OX40L/TNFα antibody with half-life-extension, delivering an optimized exposure and dosing profile with best-in-class potential. This would enable a highly differentiated, convenient treatment approach for people living with a range of autoimmune and inflammatory conditions such as HS, Crohn’s disease and ulcerative colitis.

About NAV-240
NAV-240, is a clinical-stage bispecific antibody against OX40L and TNFα, two clinically-validated targets that are critical in the pathogenesis of several difficult-to-treat inflammatory diseases. Dual targeting of both OX40L and TNFα-driven signaling pathways may improve upon the efficacy of either monotherapy alone as a potential treatment option for complex, heterogeneous diseases with unmet medical needs.

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 overall prevalence estimates as high as 4% in the U.S. Over one million people in the US 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, our mission is powered by a $100M Series A financing, co-led by RA Capital Management and Forbion, giving us the resources to pursue therapies for those who need them most.

Contacts:
Business or Investor Inquiries:
Mark McLaughlin
info@navigatormedicines.com

Media Inquiries:
Arran Attridge
arran@attridgecomms.com