MYR301 STUDY INFORMATION

STUDY DESIGN

The MYR301 study was a multicenter, open-label, randomized, Phase 3 study in adults
with chronic HDV with or without cirrhosis (n=100)¹

^a2-mg Hepcludex is the approved dosage. Other doses have been studied as part of the dose-finding study.

BASELINE CHARACTERISTICS

PRIMARY ENDPOINT

A combined response of undetectable
HDV RNA or decrease of ≥2 log₁₀ IU/mL
from baseline and ALT normalization at
48 weeks

SELECT SECONDARY ENDPOINTS

Undetectable HDV RNA at Week 48
ALT normalization at Week 48
Sustained virologic responses at Weeks 24 and 48

PRIMARY ENDPOINT

A combined response of undetectable
HDV RNA or decrease of ≥2 log₁₀ IU/mL
from baseline and ALT normalization at
48 weeks

SELECT SECONDARY ENDPOINTS

Undetectable HDV RNA at Week 48
ALT normalization atWeek 48
Sustained virologic responses at Weeks 24 and 48

HDV RNA REDUCTION

Hepcludex demonstrated a reduction in HDV RNA levels at Week 24
compared to no treatment^1,a

MYR301 ALT

Hepcludex demonstrated an improvement in normalized ALT at
Week 24 compared to no treatment^1,a

MYR301 COMBINED RESPONSE

Hepcludex demonstrated ALT normalization and a significant reduction in
HDV RNA levels at Week 24 compared to no treatment^1,a,b

OVERVIEW OF ADVERSE EVENTS

SAFETY PROFILE

Hepcludex 2 mg demonstrated a favorable safety profile with low discontinuation rates¹

Injection-site reactions were
rare and mostly mild in grade1^1,a

No symptomatic elevations in total
bile salts were observed in the
Hepcludex 2 mg group1¹

REFERENCES:
1. Assessment report: Hepcludex: International non-proprietary name: bulevirtide. Procedure No. EMEA/H/C/004854/0000. May 28, 2020. Accessed November 3, 2021. https://www.ema.europa.eu/en/documents/assessment-report/hepcludex-eparpublic-assessment-report_en.pdf. 2. Wedemeyer H, Aleman S, Andreone P, et al. Bulevirtide monotherapy at low and high doses in patients with chronic hepatitis delta: 24-Week interim data of the Phase 3 MYR301 study. Poster Presentation: International Liver Congress. June 23-26, 2021. Poster # 2730.

READ INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION
Hepcludex is geïndiceerd voor de behandeling van chronische infectie met het hepatitis delta-virus (HDV) bij plasma- (of serum-) HDV-RNA-positieve volwassen patiënten met gecompenseerde leverziekte.

Dit product is onderworpen aan aanvullende monitoring.