- First subject dosed with NAV-240 in multiple-ascending dose study in healthy volunteers
- Primary objective of Phase 1b study is safety, tolerability, PK and PD of NAV-240 after repeated administration
- Trial expected to enroll approximately 24 subjects across three dosing cohorts with interim data available before year-end 2025
Navigator Medicines, Inc., a clinical-stage biotech company leading the advancement of biologics for targeted immune regulation and restoration, today announced that it dosed the first subjects in a Phase 1b multiple-ascending dose (MAD) study in healthy volunteers. The Phase 1b study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NAV-240 after repeated administration. Navigator plans to leverage the Phase 1b data set to subsequently initiate studies in patients with inflammatory conditions and autoimmune diseases.
“We are delighted to have successfully dosed the first subjects in our multi-dose study of NAV-240 to support the initiation of our planned patient studies later this year,” said Dana McClintock, Chief Medical Officer of Navigator Medicines. “We see significant opportunity for NAV-240 to target multiple distinct inflammatory and immunological pathways that are pathogenic in patients with difficult-to-treat disease. Given the high unmet need for many patients with autoimmune and inflammatory diseases, we are encouraged that our mechanism of action, specifically the dual inhibition of both TNFα and OX40L in a tetravalent antibody format, may provide an improved approach for patients suffering from these challenging diseases.”
Navigator is also advancing NAV-242, a next-generation, engineered anti-OX40L/TNFα antibody, with half-life-extension, which has the potential for optimized exposure and dosing profile to provide a highly differentiated, convenient treatment approach for patients suffering from conditions such as hidradenitis suppurativa, and several other inflammatory conditions and autoimmune diseases such as Crohn’s disease and Ulcerative Colitis.
“It’s an exciting time for Navigator as we strive to make an impact for patients living with difficult-to-treat autoimmune and inflammatory diseases,” said Tosh Butt, Chief Executive Officer of Navigator. “Our pipeline of anti-OX40L/TNFα bispecifics, including NAV-240 and NAV-242, as well as other OX40L-targeted programs aims to advance new treatment options for patients with high unmet medical needs.”
About NAV-240
NAV-240, formerly known as IMB101, 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.
Prevalence estimates suggest a range of 0.7 to 1.0% (with some estimates as high as 4.0%) in the US – with three times more females affected than males. Well over one million people in the US live with moderate-to-severe HS, with only 350k currently seeking treatment. Given this magnitude of disease burden, and several new biologics set to enter the market in the coming years, the HS market is projected to grow from $2bn in 2025 to over $10bn by 2031.
About Navigator Medicines
Navigator Medicines is a clinical-stage biopharmaceutical company leading the advancement of biologics for targeted immune regulation & restoration. Founded in 2024, as a subsidiary of Sera Medicines, through a $100M Series A financing, co-led by RA Capital Management and Forbion, as a subsidiary of Sera Medicines, the Company is committed to developing new therapies for patients living with complex, heterogeneous autoimmune diseases. For more information, visit navigatormedicines.com.
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