#NKTR "announced the presentation of additional clinical data from the Phase 1b study evaluating multiple ascending doses of NKTR-358, a first-in-class T regulatory cell stimulator, currently in development for the treatment of a range of autoimmune disorders, including systemic lupus erythematosus (SLE).
The randomized, double-blind, multiple-ascending dose Phase 1b data from the study being presented at 2020 ACR evaluated safety, pharmacokinetics (PK) and pharmacodynamics (PD) in a total of 48 SLE patients across 4 separate ascending dose cohorts who received subcutaneous Q2W doses of NKTR-358 (n=9 per cohort) or placebo (n=3 per cohort). Subjects were treated for a total of six weeks.
Key conclusions from today's data presentation at ACR 2020 include:
NKTR-358 was safe and well tolerated with a similar safety profile for single and repeat doses in patients with mild-to-moderate SLE as was observed in healthy volunteers from a prior Phase 1 study
A selective, dose-dependent expansion of CD25bright Tregs was observed, which was maintained through multiple NKTR-358 administrations
Treg induction was further supported by a correlation between the number of Tregs and the extent of demethylated FoxP3
Increases in Treg activation markers (CD25, Helios, and CTLA-4) and genes associated with Treg regulation were observed with NKTR-358
Low-level increases in NK cell numbers occurred in most patients at the highest NKTR-358 dose; the CD56bright NK cell population was more sensitive than the CD56dim
A dose-dependent reduction in CLASI-A1 score was seen with NKTR-358 treatment, which supports further exploration in patients with moderate-to-severe SLE
No observed changes in SLEDAI or joint scores were noted due to the short treatment duration in this study
Nektar will host a call today for analysts and investors to review the data presented at ACR 2020. Details of the call are as follows:
Date and Time: Wednesday, November 4, 2020 at 4:15 p.m. Eastern Standard Time
Dial- in: (877) 881-2183 (toll-free) or (970) 315-0453 (access code 7083115)
Investors and analysts can view slides and listen to the live audio webcast of the presentation at https://edge.media-server.com/mmc/p/yppmbgt9.
See press release HERE.
See our NKTR-358 AmpCard to learn more.