• Full Study Results Expected in Q1 2026
• Further Clinical Development of NAV-240 in Hidradenitis Suppurativa to Begin in Early 2026

SCOTCH PLAINS, NJ., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Navigator Medicines Inc., a clinical-stage biotech company pioneering the advancement of best-in-class bispecific antibodies (bsAb) for inflammatory disorders and autoimmune diseases in areas of high unmet need, today announced successful completion of participant visits in the Phase 1b multiple-ascending dose study (MAD) of NAV-240.

The Phase 1b trial of NAV-240 studied its safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity after repeat dosing in 24 healthy volunteers. Navigator plans to share results in Q1 2026 which will inform the clinical path for NAV-240 and NAV-242, the two most advanced bsAb from Navigator’s potential best-in-class anti-OX40L and anti-TNFα bsAb development program.

NAV-240 is a bsAb that targets both OX40L and TNFα, two clinically-validated targets that are key drivers of several complex and difficult-to-treat inflammatory disorders, such as hidradenitis suppurativa (HS). The Phase 1b MAD study of NAV-240 aims to build on the positive safety and tolerability profile demonstrated in the Ph1a single ascending dose (SAD) study presented earlier this year.

“Achieving LPLV in the Phase 1b MAD study of NAV-240 is an exciting step forward in our mission to unlock the potential of OX40L and TNFα dual inhibition, with the goal to raise the efficacy bar for hidradenitis suppurativa treatment,” said Dana McClintock, M.D., Chief Medical Officer of Navigator Medicines. “We are advancing NAV-240 at pace and are on track to share the Phase 1b results in Q1 2026 and proceed with NAV-240 Phase 2 evaluation in HS.”  

Navigator Medicines is pioneering a portfolio of best-in-class treatments for inflammatory and autoimmune diseases, focusing on OX40L combination approaches. Building on the positive profile of NAV-240, the company's next-generation candidate is NAV-242. This OX40L and anti-TNFα bsAb is engineered for extended half-life, promising an optimized exposure and dosing schedule with best-in-class potential. If approved, NAV-242 could offer a highly convenient, differentiated treatment for conditions like hidradenitis suppurativa, 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 NAV-242
NAV-242 is a next-generation, preclinical bispecific antibody designed to simultaneously inhibit OX40L and TNFα. NAV-242 has been engineered by the Navigator Medicines team to extended its half-life and enable optimized dosing offering a potentially highly 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.

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