AnaptysBio Faces Another Setback For Imsidolimab, Stalls Work In Skin Scarring Indication

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  • AnaptysBio Inc ANAB announced topline data from its HARP Phase 2 trial of imsidolimab for moderate-to-severe hidradenitis suppurativa (HS). 
  • The trial indicated that imsidolimab was safe and well tolerated. However, it did not demonstrate efficacy over placebo in the trial's primary and key secondary endpoints. 
  • Clinical development of imsidolimab is being discontinued in hidradenitis suppurativa.
  • AnaptysBio stopped working on the drug for acne settings after failed Phase 2 trial.
  • Hidradenitis suppurativa is a painful, long-term skin condition that causes abscesses and scarring on the skin. It occurs near hair follicles with sweat glands, usually around the groin, bottom, breasts, and armpits.
  • Imsidolimab previously demonstrated efficacy and safety in the GALLOP Phase 2 trial in generalized pustular psoriasis (GPP). Enrollment of the GEMINI-1 GPP Phase 3 registrational trial is ongoing, and topline data is anticipated in Q4 2023. 
  • The company plans to out-license investigational imsidolimab before potential FDA approval to treat GPP.
  • AnaptysBio also continues to advance the development of two wholly-owned immune cell modulators targeting PD-1 and BTLA for autoimmune and inflammatory diseases. 
  • Topline data from the AZURE Phase 2 trial of rosnilimab, a PD-1 agonist antibody, in moderate-to-severe alopecia areata is anticipated in Q1 of 2023.
  • The company expects to file a U.S. IND for an initial Phase 2 trial of ANB032, a BTLA agonist antibody, in Q4 of 2022.
  • Price Action: ANAB shares are down 3.88% at $22.32 on the last check Thursday.
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