U.S. Markets closed
  • S&P 500

    4,026.12
    -1.14 (-0.03%)
     
  • Dow 30

    34,347.03
    +152.97 (+0.45%)
     
  • Nasdaq

    11,226.36
    -58.96 (-0.52%)
     
  • Russell 2000

    1,869.19
    +5.67 (+0.30%)
     
  • Crude Oil

    76.28
    -1.66 (-2.13%)
     
  • Gold

    1,754.00
    +8.40 (+0.48%)
     
  • Silver

    21.43
    +0.06 (+0.29%)
     
  • EUR/USD

    1.0405
    -0.0008 (-0.0728%)
     
  • 10-Yr Bond

    3.6910
    -0.0150 (-0.40%)
     
  • Vix

    20.50
    +0.08 (+0.39%)
     
  • GBP/USD

    1.2091
    -0.0023 (-0.1935%)
     
  • USD/JPY

    139.1000
    +0.5100 (+0.3680%)
     
  • BTC-USD

    16,519.21
    +6.36 (+0.04%)
     
  • CMC Crypto 200

    386.97
    +4.32 (+1.13%)
     
  • FTSE 100

    7,486.67
    +20.07 (+0.27%)
     
  • Nikkei 225

    28,283.03
    -100.06 (-0.35%)
     

Alnylam/Regeneron-Backed NASH Candidate Shows Encouraging Safety Profile In Healthy Volunteers

  • Alnylam Pharmaceuticals Inc (NASDAQ: ALNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGNannounced preliminary Phase 1 data supporting the clinical advancement of ALN-HSD for nonalcoholic steatohepatitis (NASH).

  • ALN-HSD is an investigational RNAi therapeutic targeting HSD17B13.

  • After single-dose evaluation in healthy adult volunteers (Part A), multiple doses of ALN-HSD are being studied in adult patients with NASH (Part B).

  • Patients in the first two Part B cohorts (200 and 400 mg quarterly) have completed at least six months on the study.

  • The remaining cohorts explore a lower dose or a later biopsy time point.

  • Related: Alnylam Posts Mid-Stage Study Data From Regeneron-Partnered Kidney Disease Drug.

  • In the first two Part B cohorts, ALN-HSD was associated with robust target knockdown and numerically lower liver enzymes and nonalcoholic fatty liver disease Activity Score over six months in patients receiving ALN-HSD (N=20) relative to placebo (N=4).

  • The study was not powered to achieve statistical significance on these endpoints, and the primary outcome measure is the frequency of adverse events.

  • ALN-HSD has exhibited an encouraging safety and tolerability profile.

  • The most common treatment-emergent adverse event in healthy subjects treated with ALN-HSD (N=44) was injection site reaction.

  • The companies plan to initiate a Phase 2 study in adult patients with NASH in late 2022.

  • Price Action: REGN shares are down 0.58% at $693.60, and ALNY is down 0.61% at $207.00 on the last check Thursday.

See more from Benzinga

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.