NASH - January 2021

NASH - January 2021

FDA cleared IND for TERN-501 Phase 1 trial for the treatment of NASH

19 Jan 2021

Terns Pharmaceuticals – TERN-501 (THR-β agonist, Phase 1); TERN-101 (FXR agonist, Phase 2a)

  • TERN-501 will be Terns’ third NASH candidate to enter clinical trials in the US
  • The molecule enhanced metabolic stability and liver distribution, characteristics that are intended to improve safety and efficacy in NASH patients
  • Trial is designed to incorporate both single ascending dose and multiple ascending dose cohorts to assess the safety, tolerability, and pharmacokinetics of TERN-501, as well as the reduction in serum lipid levels as an early marker of target engagement

Jan 12, 2021: Terns completed enrollment in Phase 2a clinical trial of TERN-101 in NASH patients

  • Enrollment was completed in LIFT study. Trial details: TERN-101 vs Placebo; N=101; Primary outcome: Incidence of adverse events; Active, not recruiting; Location: US
  • TERN-101 has demonstrated a differentiated tolerability profile and improved target engagement in the liver

Jan 05, 2021: Terns closed $87 million Series C financing to advance its NASH portfolio.

  • The financing round was led by Deerfield Management Company alongside a strategic equity investment by Eli Lilly with participation from OrbiMed Advisors, Lilly Asia Ventures, Vivo Capital, Samsara Capital, Suvretta Capital Management and several other new investors

Terns expects the initiation of Phase 1 in H1’21 and data in H2’21

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CI Scientists Remarks:

  • With the Series C financing received, Terns’ will be bullish to achieve next milestones.
  • Terns’ NASH pipeline

Molecule

Stage of development

Anticipated milestones

TERN-101

Phase 2

Topline data: H2’21

TERN-201

Phase 1

Phase 1b initiation: H1’21; Topline data: H1’22

TERN-501

Phase 1 (IND cleared)

Trial initiation: H1’21; Topline data: H2’21

  • The company also plans to file for an IPO to raise up to $100 million

– Akshat Gulati, CI Scientists

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