Item 7.01 Regulation FD Disclosure.
On
The information furnished under this Item 7.01, including Exhibit 99.1 and
Exhibit 99.2, shall not be deemed "filed" for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or subject to the liabilities of
that section. The information shall not be deemed incorporated by reference into
any other filing with the
Item 8.01 Other Information.
On
KALM-2 is a Phase 3, global, multicenter, randomized, double-blind,
placebo-controlled, 12-week trial (with a 52-week open label extension phase)
designed to evaluate the safety and efficacy of 0.5 mcg/kg KORSUVA Injection in
473 hemodialysis patients with moderate-to-severe pruritus. The primary efficacy
endpoint is the proportion of patients achieving at least a three-point
improvement from baseline in the weekly mean of the daily 24-hour worst itching
intensity numeric rating scale, or WI-NRS, score at week 12. Secondary endpoints
include assessment of the proportion of patients achieving four-point or greater
improvement from baseline in weekly mean of the daily 24-hour WI-NRS score at
week 12, as well as itch-related quality of life changes measured using the
validated self-assessment
Primary Endpoint: The proportion of patients on 0.5 mcg/kg of KORSUVA Injection achieving a three-point or greater improvement from baseline in the weekly mean of the daily 24 hour WI-NRS score at week 12 was 54% vs. 42% for patients on placebo (p=0.02).
Key Secondary Endpoint: The proportion of patients on 0.5 mcg/kg of KORSUVA Injection achieving a four-point or greater improvement from baseline in the weekly mean of the daily 24 hour WI-NRS score at week 12 was 41% vs. 28% for patients on placebo (p=0.01).
Itch-Related Quality of Life Measures. Patients on KORSUVA Injection experienced
a 12% and 29% numerical improvement in the average total
Safety and Tolerability: KORSUVA was generally well-tolerated with a safety profile consistent with that seen in KALM-1 and in the KORSUVA clinical program in patients with CKD-aP. Overall, the incidence of adverse events ("AEs") and serious AEs were similar across both KORSUVA and placebo groups. The most common treatment-emergent AEs reported in >5% of patients were diarrhea (8.1% KORSUVA vs. 5.5% placebo), fall (6.8% KORSUVA vs. 5.1% placebo), vomiting (6.4% KORSUVA vs. 5.9% placebo), nausea (6.4% KORSUVA vs. 4.2% placebo) and dizziness (5.5% KORSUVA vs. 5.1 % placebo).
The Company remains on track to submit its New Drug Application to the
Forward-looking Statements
Statements contained in this Current Report on Form 8-K regarding matters that
are not historical facts are "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Examples of these
forward-looking statements include statements concerning plans, strategies and
expectations for the future, including the planned timing of future regulatory
submissions. Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or implied by such
forward-looking statements. Risks are described more fully in the Company's
filings with the
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. 99.1 Press release datedApril 21, 2020 . 99.2 Presentation datedApril 21, 2020 .
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