June 23, 2020

Impact: Moderate

  • Researchers at the University of Oxford reported results from a randomized study of patients with severe cases of COVID-19, with either oral or intravenous administration of the widely available steroid dexamethasone, compared to usual care.
  • 2,104 patients were randomized to receive dexamethasone 6 mg once per day (either by mouth or by intravenous injection) for ten days and were compared with 4,321 patients randomized to usual care alone.
  • Dexamethasone reduced deaths by one-third in ventilated patients and by one fifth in other patients receiving oxygen only. There was no benefit among those patients who did not require respiratory support.
  • Full results have not yet been published or peer reviewed.
  • The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was established as a randomized clinical trial to test a range of potential treatments for COVID-19, including low-dose dexamethasone. Over 11,500 patients have been enrolled at over 175 NHS hospitals in the UK.

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June 23, 2020

Impact: High

  • Inventiva has released topline results from the phase 2b NATIVE trial of its pan-PPAR agonist, lanifibranor, for the treatment of NASH.
  • The primary endpoint of the trial, the Steatosis Activity Fibrosis (SAF) score at Week 24 was met, along with all other secondary outcomes at the same time point, including NASH resolution with no worsening of fibrosis and improvement of liver fibrosis with no worsening of NASH.
  • The proportion of patients achieving a reduction in SAF score of ≥2 at Week 24 was 41% and 49% in the lanifibranor 800mg and 1200mg treatment groups respectively, compared with 27% in the placebo group (p=0.061 and p=0.004).

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June 2, 2020

Impact: High

Gilead and Galapagos have announced positive topline results from the phase 2b/3 randomized, double-blind, placebo-controlled of the oral selective JAK1 inhibitor given once-daily. The results were particularly favorable for biologic-naive patients.

The study evaluated filgotinib 200mg, filgotinib 100mg and placebo in 1,348 biologic-naïve or biologic-experienced adult patients with moderate to severe active ulcerative colitis.

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June 2, 2020

Impact: High

During the virtual AAN 2020 conference, Biogen presented the baseline characteristics of participants in its phase 2 SPARK study of cinpanemab in PD. On May 20th, a month after the virtual conference, AAN opened its presentations to be viewed by the public without need for AAN registration, allowing us to view the slides on the SPARK study.

The study design for SPARK includes 3 treatment arms with cinpanemab doses of 250mg, 1250mg, and 3500mg. 357 patients are enrolled, split into two cohorts, the first consisting of 29 patients undergoing an intensive PK evaluation:

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