– Preliminary Phase 2 SOLSTICE trial data
reinforce the potential of both regimens to be transformative
treatments in an area of high unmet medical need –
– Conference call scheduled for June 5, 2024,
at 6:00 a.m. ET / 12:00 p.m. CEST –
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new
preliminary data from its Phase 2 SOLSTICE hepatitis delta clinical
trial evaluating tobevibart, an investigational monoclonal
antibody, and elebsiran, an investigational small interfering
ribonucleic acid, for the treatment of people living with chronic
hepatitis delta. Preliminary data from the Phase 2 trial show
treatment with tobevibart alone or in combination with elebsiran
was generally well tolerated and participants achieved high rates
of virologic response at weeks 12 and 24, durable virologic
response through 48 weeks, and high rates of ALT normalization.
The Company will host an investor conference call on June 5 at
6:00 a.m. ET / 12:00 p.m. CEST to discuss these data. Originally
accepted as a late-breaker poster, these data will be presented in
more detail in an oral presentation on June 8 at the European
Association for the Study of the Liver, EASL™ Congress 2024.
Preliminary data from the six participants reported on at the
2023 American Association for the Study of Liver Diseases (AASLD)
The Liver Meeting® demonstrated sustained virologic
response:
- These participants received 12 weeks of either tobevibart or
elebsiran monotherapy and then rolled over into combination
therapy. All 6 participants remain on treatment. At the time of the
analysis, 5 out of the 6 participants had reached 48 weeks of
combination therapy and 1 had reached 40 weeks of combination
therapy.
- All 6 participants showed sustained virologic response at time
of last visit
- 100% (6 of 6) achieved HDV RNA < limit of detection (LOD) or
≥ 2 log10 IU/mL decrease from baseline
- 50% (3 of 6) achieved ALT normalization
- 50% (3 of 6) achieved the combined endpoint*
- Furthermore, 100% (6 of 6) achieved HDV RNA < the lower
limit of quantification (LLOQ), 100% (6 of 6) achieved HDV RNA <
LOD, and 83% (5 of 6) achieved HDV RNA target not detected
(TND)
- The majority of adverse events were Grade 1-2 and transient in
nature with no reported serious adverse events, no ALT flares and
no Grade 2 or higher elevations in liver function tests (LFTs) were
observed.
Preliminary de novo combination of tobevibart + elebsiran
(monthly dosing) data demonstrated rapid and high rates of
virologic suppression and ALT normalization:
- Week 12: Among 27 participants
- 100% (27 of 27) achieved HDV RNA < LOD or ≥ 2 log10 IU/mL
decrease from baseline
- 44% (12 of 27) achieved ALT normalization
- 44% (12 of 27) achieved the combined endpoint*
- Furthermore, 52% (14 of 27) achieved HDV RNA < LLOQ, 37% (10
of 27) achieved HDV RNA < LOD, and 15% (4 of 27) achieved HDV
RNA TND
- Week 24: Among 11 participants
- 100% (11 of 11) achieved HDV RNA < LOD or ≥ 2 log10 IU/mL
decrease from baseline
- 64% (7 of 11) achieved ALT normalization
- 64% (7 of 11) achieved the combined endpoint*
- Furthermore, 100% (11/11) achieved HDV RNA < LLOQ, 91% (10
of 11) achieved HDV RNA < LOD, and 55% (6 of 11) achieved HDV
RNA TND
- Similar rates of virologic suppression and ALT normalization
were observed in participants who are non-cirrhotic (n=6) and those
with compensated cirrhosis (CPT-A, n=5).
- The majority of adverse events were Grade 1-2 and transient in
nature with no treatment-related serious adverse events, no ALT
flares and no Grade 2 or higher elevations in LFTs were
observed.
Preliminary tobevibart monotherapy (twice monthly dosing)
data demonstrated high rates of virologic suppression and ALT
normalization:
- Week 12: Among 26 participants
- 73% (19 of 26) achieved HDV RNA < LOD or ≥ 2 log10 IU/mL
decrease from baseline
- 54% (14 of 26) achieved ALT normalization
- 38% (10 of 26) achieved the combined endpoint*
- Furthermore, 27% (7 of 26) achieved HDV RNA < LLOQ, 19% (5
of 26) achieved HDV RNA < LOD, and 8% (2 of 26) achieved HDV RNA
TND
- Week 24: Among 11 participants
- 55% (6 of 11) achieved HDV RNA < LOD or ≥ 2 log10 IU/mL
decrease from baseline
- 64% (7 of 11) achieved ALT normalization
- 55% (6 of 11) achieved the combined endpoint*
- Furthermore, 55% (6 of 11) achieved HDV RNA < LLOQ, 46% (5
of 11) achieved HDV RNA <LOD, and 18% (2 of 11) achieved HDV RNA
TND
- The majority of adverse events were Grade 1-2 and transient in
nature with no serious adverse events, no ALT flares and no Grade 2
or higher elevations in LFTs were observed.
“As the most severe form of viral hepatitis, chronic hepatitis
delta poses a significant threat to millions worldwide and often
leads to life-threatening complications such as cirrhosis and liver
cancer. Despite the urgent need for effective and convenient
therapies, the options for patients remain limited,” said Tarik
Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital
Beaujon, APHP, Clichy, France, and at the University of Paris, and
Head of Viral Hepatitis at INSERM UMR1149, France. “The impressive
reduction in HDV RNA observed in the preliminary SOLSTICE trial
data surpasses any previous therapy reported to date and highlights
the promise of tobevibart and elebsiran in addressing this critical
unmet need.”
Phase 2 SOLSTICE Trial Preliminary Data
Summary Table:
Combo Q4W rollover
(monthly)1
N = 6
De novo
combination of
tobevibart +
elebsiran (monthly)
N = 32
tobevibart
monotherapy (Q2W)
N = 33
Week
12
n=6
Week
24
n=6
Week
48
n=52
Week
12
n=27
Week
24
n=11
Week
12
n=263
Week
24
n=113
1) n (%) Virologic Response
(HDV RNA < LOD or ≥ 2 log10 IU/mL decrease from
baseline)
6/6
(100%)
6/6
(100%)
5/5
(100%)
27/27
(100%)
11/11
(100%)
19/26
(73%)
6/11
(55%)
2) n (%) HDV RNA <
LLOQ
6/6
(100%)
6/6
(100%)
5/5
(100%)
14/27
(52%)
11/11
(100%)
7/26
(27%)
6/11
(55%)
3) n (%) HDV RNA <
LOD
5/6
(83%)
5/6
(83%)
5/5
(100%)
10/27
(37%)
10/11
(91%)
5/26
(19%)
5/11
(46%)
4) n (%) HDV RNA TND
4/6
(67%)
3/6
(50%)
4/5
(80%)
4/27
(15%)
6/11
(55%)
2/26
(8%)
2/11
(18%)
5) n (%) ALT
normalization
2/6
(33%)
2/6
(33%)
2/5
(40%)
12/27
(44%)
7/11
(64%)
14/26
(54%)
7/11
(64%)
6) n (%) Combined Endpoint
(CE)
(Rows 1 + 5)
2/6
(33%)
2/6
(33%)
2/5
(40%)
12/27
(44%)
7/11
(64%)
10/26
(38%)
6/11
(55%)
1 For Combo Q4W rollover baseline: Day 1
of combination therapy, 12 weeks additionally on monotherapy
2 Rollover cohort: All 6 participants
remain on therapy. At the time of analysis, 5 participants were at
week 48 and 1 was at week 40 of the combination therapy. The
participant at week 40 has achieved HDV RNA TND, ALT normalization,
and the CE
3 Responses on ITT basis and includes 4
participants who discontinued treatment, 2 due to adverse events
and 2 who withdrew from the trial
HDV: Hepatitis Delta Virus
RNA: RiboNucleic Acid
LLOQ: lower limit of quantification = 63
IU/mL
LOD: limit of detection = 14 IU/mL
TND: target not detected (undetectable
viral load)
The Company is on track to report additional 24-week treatment
data for all approximately 60 SOLSTICE participants in the fourth
quarter of 2024.
“The preliminary data from our Phase 2 hepatitis delta trial
provide compelling evidence that either tobevibart and elebsiran in
combination or tobevibart as monotherapy could represent a
transformative treatment option for individuals living with this
devastating disease,” said Marianne De Backer, M.Sc., Ph.D., MBA,
Vir’s Chief Executive Officer. “Recognizing the critical need for
improved treatment options, we are committed to working closely
with regulatory authorities to determine the next steps to bring
these promising candidates to patients in need as expeditiously as
possible.”
EASL oral presentation details:
- Title: Efficacy and safety of tobevibart (VIR-3434)
alone or in combination with elebsiran (VIR-2218) in participants
with chronic hepatitis delta virus infection: preliminary results
from the phase 2 SOLSTICE trial in non-cirrhotic and compensated
cirrhotic participants (OS-127) Session: Viral hepatitis
B/D: Therapy Date: Saturday, June 8 Time: 11:45 a.m.
CEST (5:45 a.m. EDT) Presenter: Tarik Asselah, M.D., Ph.D.,
Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy,
France, and at the University of Paris, and Head of Viral Hepatitis
at INSERM UMR1149, France
A live webcast of the June 5 investor call will be made
available on https://investors.vir.bio and a recording will be
archived there for 30 days.
The EASL oral scientific presentation will be made available
under Events & Presentations in the Investors section of the
Vir website following the presentation on June 8th.
About the Phase 2 SOLSTICE Trial
The SOLSTICE trial (NCT05461170) is evaluating the safety,
tolerability and efficacy of tobevibart and elebsiran for the
treatment of people living with chronic hepatitis delta. One cohort
is evaluating the combination of tobevibart and elebsiran dosed
every 4 weeks with a second cohort evaluating tobevibart
monotherapy every 2 weeks. Approximately 50% of participants have
compensated cirrhosis.
About Tobevibart (VIR-3434)
Tobevibart is an investigational subcutaneously administered
antibody designed to inhibit entry of hepatitis B and hepatitis
delta viruses into hepatocytes, neutralize both hepatitis B virus
and hepatitis delta virus virions and to reduce the level of
virions and subviral particles in the blood. Tobevibart, which
incorporates Xencor’s Xtend™ and other Fc technologies, has been
engineered to have an extended half-life and was identified using
Vir’s proprietary monoclonal antibody discovery platform.
About Elebsiran (VIR-2218)
Elebsiran is an investigational subcutaneously administered
hepatitis B virus-targeting small interfering ribonucleic acid
(siRNA) designed to degrade hepatitis B virus RNA transcripts and
limit the production of hepatitis B surface antigen. Vir believes
it has the potential to have direct antiviral activity against
hepatitis B virus and hepatitis delta virus. It is the first siRNA
in the clinic to include Enhanced Stabilization Chemistry Plus
(ESC+) technology to enhance stability and minimize off-target
activity, which potentially could result in an increased
therapeutic index. Elebsiran is the first asset in the Company’s
collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical
trials.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is an immunology company focused on
powering the immune system to transform lives by treating and
preventing infectious diseases and other serious conditions,
including viral-associated diseases. Vir has assembled two
technology platforms that are designed to modulate the immune
system by exploiting critical observations of natural immune
processes. Its current clinical development pipeline consists of
product candidates targeting hepatitis delta and hepatitis B
viruses, and human immunodeficiency virus. Vir has several
preclinical candidates in its pipeline, including those targeting
influenza A and B, COVID-19, RSV/MPV and HPV. Vir routinely posts
information that may be important to investors on its website.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “may,” “will,” “plan,” “potential,” “aim,”
“expect,” “anticipate,” “promising” and similar expressions (as
well as other words or expressions referencing future events,
conditions or circumstances) are intended to identify
forward-looking statements. These forward-looking statements are
based on Vir’s expectations and assumptions as of the date of this
press release. Forward-looking statements contained in this press
release include, but are not limited to, statements regarding Vir’s
strategy and plans, the potential clinical effects of tobevibart
and elebsiran, the potential benefits, safety and efficacy of
tobevibart and elebsiran, data from Vir’s multiple ongoing trials
evaluating tobevibart and elebsiran, Vir’s plans and expectations
for its CHD and CHB programs, and risks and uncertainties
associated with drug development and commercialization. Many
factors may cause differences between current expectations and
actual results, including unexpected safety or efficacy data or
results observed during clinical trials or in data readouts; the
occurrence of adverse safety events; risks of unexpected costs,
delays or other unexpected hurdles; difficulties in collaborating
with other companies; successful development and/or
commercialization of alternative product candidates by Vir’s
competitors; changes in expected or existing competition; delays in
or disruptions to Vir’s business or clinical trials due to
geopolitical changes or other external factors; and unexpected
litigation or other disputes. Drug development and
commercialization involve a high degree of risk, and only a small
number of research and development programs result in
commercialization of a product. Results in early-stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. You should not place undue reliance on these statements,
or the scientific data presented. Other factors that may cause
actual results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
Vir’s filings with the U.S. Securities and Exchange Commission,
including the section titled “Risk Factors” contained therein.
Except as required by law, Vir assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
* The combined endpoint (CE) is a combined response of an
undetectable HDV RNA level, or a level that decreased by at least 2
log10 IU per milliliter from baseline, and normalization of the
alanine aminotransferase (ALT) level.
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version on businesswire.com: https://www.businesswire.com/news/home/20240605189185/en/
Media Carly Scaduto Senior Director, External
Communications cscaduto@vir.bio +1 314-368-5189
Investors Richard Lepke Senior Director, Investor
Relations rlepke@vir.bio +1 978-973-9986
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