A New Hidradenitis Suppurativa Drug Is Now Being Tested in Patients

Biologics that block TNF, a well-known driver of inflammation, help some people with hidradenitis suppurativa (HS). But many don’t get enough relief, or relief that lasts. A new experimental antibody takes aim at two inflammatory pathways at once instead of just one.

As reported by Dermatology Times, Navigator Medicines announced that the FDA had cleared a phase 2a trial of NAV-240 in people with moderate to severe HS. The company has since begun dosing patients in the trial.

How it works

NAV-240 blocks TNF, the same target as some existing HS treatments, along with a second molecule called OX40 ligand, which helps switch on immune cells that keep inflammation going. The idea is that tackling both together could calm inflammation more effectively than hitting a single target, though that still has to be proven in trials.

What early testing showed

In a phase 1 study of 40 healthy volunteers, the drug was generally well tolerated across a range of doses. No serious side effects were reported, and no one stopped treatment because of a reaction. Blood levels of the drug rose in proportion to the dose, which helps researchers plan doses for later trials.

Researchers saw drops in TARC, a blood marker associated with inflammatory skin diseases, a sign the drug was doing what it was designed to do biologically. Those findings don’t show that it helps HS, but they supported further testing in patients.

Navigator has since reported results from a separate study of repeated NAV-240 doses in 24 healthy volunteers. It found no serious adverse events or adverse events that caused participants to stop treatment, and researchers observed dose-dependent drops in inflammatory markers. Neither study tested whether NAV-240 improves HS symptoms.

A longer-lasting version is in the works

The company is also developing NAV-242, a newer version built to stay in the body longer, which could mean less frequent dosing. Its first human study has begun and is evaluating safety and how the drug behaves in the body. Initial results are expected in late 2026.

What’s still unknown

Both NAV-240 and NAV-242 are still investigational, and there’s no data yet on how well either one works for HS. Larger, longer studies will be needed to show whether targeting two pathways offers clear benefits over existing treatments. Navigator expects results from the phase 2a NAV-240 trial in the second half of 2027. For people who haven’t found lasting relief from current biologics, it’s an approach worth keeping an eye on.