KPL-716

KPL-716

Phase 2

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Rationale

Studies link many pruritic and inflammatory diseases to both IL-31 and OSM via signaling through OSMRβ. By targeting both pathways simultaneously, KPL-716 may disrupt the pathologic cycle in patients afflicted by a variety of pruritic diseases.

  • Internal research shows IL-31, OSM, and OSMRβ mRNA are all upregulated in lesional biopsies of PN subjects with severe pruritus versus normal healthy controls.
  • In our single-dose Phase 1b study in 20 subjects (randomized 1:1) with atopic dermatitis, a disease that links IL-31 to pruritus, a single dose of KPL-716 resulted in 50% of subjects achieving a ≥4 point reduction on the Worst-Itch Numeric Rating Scale (WI-NRS) (considered clinically meaningful) versus 10% on placebo at week 4.
  • In our repeated-single-dose Phase 1b in 43 subjects (randomized 1:1) with atopic dermatitis, repeated-single-doses of KPL-716 resulted in 53% subjects achieving a ≥ 4-point reduction on the WI-NRS versus 26% on placebo at week 12. In an interim analysis of the data through the 12-week treatment period, KPL-716 showed a rapid and sustained reduction in WI-NRS in subjects with moderate-to-severe atopic dermatitis.

Status: Phase 2

We are currently enrolling a randomized, double-blind, placebo-controlled, adaptive design Phase 2a clinical trial of KPL-716 in subjects with PN.

  • The Phase 2a will randomize approximately 80 subjects with PN who will receive a loading dose of 720 mg of KPL-716 or placebo injected subcutaneously followed by a 360-mg dose of KPL-716 or placebo injected subcutaneously weekly for a total of 8 doses. The primary efficacy endpoint is percent change in weekly average WI-NRS.  Topline data expected in the first half of 2020.

We are currently enrolling an exploratory Phase 2 clinical trial of KPL-716 in diseases characterized by chronic pruritus.

  • The study populations include chronic idiopathic urticaria, chronic idiopathic pruritus, plaque psoriasis, lichen planus, and lichen simplex chronicus.
  • The trial is designed to identify chronic pruritic conditions where signaling through OSMRβ may be playing a role and to investigate the efficacy, safety, and tolerability of KPL-716 in reducing the moderate-to-severe pruritus experienced by these subjects.
  • We expect each cohort to enroll up to approximately 26 subjects with each subject entering with a WI-NRS at or above 7. A loading dose of 720 mg of KPL-716 or placebo injected subcutaneously followed by a 360-mg dose of KPL-716 or placebo injected subcutaneously weekly for a total of 8 doses. Interim data in a limited number of cohorts are expected in the first half of 2020.

Unmet Need

We are not aware of any current therapies approved by the FDA for the treatment of PN.

  • The treatment approach for PN ranges from topical corticosteroids and occlusive corticosteroid-containing bandages for patients who have milder forms of PN to systemic corticosteroids, ultraviolet phototherapy, and systemic therapies such as thalidomide, methotrexate, and cyclosporine for those patients whose conditions don’t improve on initial treatments. Patients have reported using opioid pain medications to attempt to control the disease in its most severe form.
  • Based on market research, we believe ~25% to 30% of subjects are refractory to treatment.

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Explore Our Pipeline

We are intent on developing an array of innovative therapies that answer the many and varied needs of patients.