Avalo Therapeutics reports positive Phase 2 LOTUS data in hidradenitis suppurativa

Avalo Therapeutics said its Phase 2 LOTUS trial of abdakibart met the primary endpoint in moderate to severe hidradenitis suppurativa and showed enough promise to move into a registrational Phase 3 program.

The company said the trial enrolled 253 adults and evaluated 150 mg and 300 mg doses. At Week 16, HiSCR75 response rates were 42.2% for the 150 mg dose and 42.9% for the 300 mg dose, compared with 25.6% for placebo.

Avalo said the study also showed statistically significant benefits on key secondary endpoints, including HiSCR50, change in IHS4 and change in draining tunnel count. The company said abdakibart was well tolerated and had a favorable safety profile.

The readout is an important step for Avalo because hidradenitis suppurativa is a chronic inflammatory skin disease with limited treatment options. The company’s next milestone is a registrational Phase 3 program, which would determine whether the drug can advance toward approval.

The topline results were first released on May 5, with follow-on coverage published on May 6. Investors often watch early-stage biotech readouts closely because they can quickly change expectations for pipeline value and future financing needs.