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Monday, February 7, 2022

RedHill COVID-19 Antiviral Cuts Mortality By 70% In Remdesivir Treated Patients

 RedHill Biopharma Ltd 

 has announced results from two recently completed prespecified analyses from the oral opaganib Phase 2/3 study in hospitalized severe COVID-19. 

  • The first analysis showed that opaganib significantly reduced mortality when given to patients who received Gilead Science Inc's  remdesivir and corticosteroids, the best available standard-of-care (SoC) for hospitalized patients. 
  • A second analysis further showed that opaganib delivered a significant benefit in time to recovery.
  • In patients receiving remdesivir and corticosteroids, opaganib demonstrated a significant 70.2% mortality benefit, with a mortality rate of 6.98% for the opaganib arm + SoC versus 23.4% for placebo + SoC by Day 42.
  • The second prespecified analysis showed opaganib delivered a significant 34% benefit in time to recovery, with 37.4% of opaganib-treated patients reaching this event versus 27.9% of patients treated with placebo + SoC.
  • Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with proposed dual anti-inflammatory and antiviral activity. 

Barclays Analyst Is 'Negatively Biased' On Kodiak Sciences

 Barclays has lowered the firm's price target on Kodiak Sciences Inc 

 to $50 from $81 and keeps an Underweight rating on the shares, representing an almost 20% downside.

  • The analyst dropped the price target to reflect a lower probability of success and lower peak penetrations.
  • After conducting a "deep dive" ahead of the "binary catalyst: of the KSI- 301 Phase 2/3 DAZZLE study in wet macular degeneration in late Q1, analyst Gena Wang continues to be "negatively biased." 
  • Last week, the Company completed enrollment in its GLEAM and GLIMMER Phase 3 trials of KSI-301, Kodiak's anti-VEGF antibody biopolymer conjugate, in diabetic macular edema (DME). 
  • The Company says topline data from the DAZZLE trial is expected this quarter and mid-year for BEACON.
  • KSI-301 is an investigational anti-VEGF therapy built on Kodiak's Antibody Biopolymer Conjugate (ABC) Platform. It is designed to maintain potent and effective drug levels in ocular tissues for longer than available agents.