Arcturus Therapeutics Announces Approval from Vietnam Ministry of Health to Proceed into Phase 2 and Phase 3a for ARCT-154, Next Generation STARR™ mRNA Vaccine Targeting SARS-CoV-2 Delta Variant and Other Variants of Concern
22 Septiembre 2021 - 6:00AM
Business Wire
Phase 1 (100 participants): both doses
completed
Phase 2 (300 participants) has initiated
Phase 3a (600 participants) on track to
initiate by end of September
Phase 3b (20,000 participants) dosing planned
for first week of October
ARCT-154 remains on track for Emergency Use
Authorization (EUA) filing in December
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”,
Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines
company focused on the development of infectious disease vaccines
and significant opportunities within liver and respiratory rare
diseases, today announced that it has completed dosing of 100
subjects for the Phase 1 portion of the ARCT-154 Phase 1/2/3
clinical trial, which consisted of a two-dose regimen with
injections 28 days apart. The Vietnam Ministry of Health has
reviewed the safety data following both injections in the Phase 1
part of the study and has given permission to proceed with
enrollment of Phase 2 and Phase 3a. Recruitment of these cohorts is
now progressing. Emergency Use Authorization filing in Vietnam
could be as soon as December 2021.
The tolerability profile of ARCT-154 in the Phase 1 study was
favorable. The Phase 2 and Phase 3a studies will evaluate safety
and immunogenicity in an additional 900 subjects in total, and the
subsequent Phase 3b will evaluate safety and efficacy in
approximately 20,000 subjects.
“We are very pleased, together with our partner Vinbiocare, to
have rapidly completed enrollment and dosing of the ARCT-154 Phase
1 study, and to receive approval to proceed into Phase 2/3a. Our
goal is to make ARCT-154 available as quickly as possible in
Vietnam, as well as many other countries where there remains a high
unmet need for effective vaccines against the Delta variant and
other variants of concern,” said Joseph Payne, President and CEO of
Arcturus.
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA
medicines and vaccines company with enabling technologies: (i)
LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology and
(iii) mRNA drug substance along with drug product manufacturing
expertise. Arcturus’ diverse pipeline of RNA therapeutic and
vaccine candidates includes mRNA vaccine programs for SARS-CoV-2
(COVID-19) and Influenza, and other programs to potentially treat
Ornithine Transcarbamylase (OTC) Deficiency, and Cystic Fibrosis
along with partnered programs including Glycogen Storage Disease
Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis
(NASH). Arcturus’ versatile RNA therapeutics platforms can be
applied toward multiple types of nucleic acid medicines including
messenger RNA, small interfering RNA, replicon RNA, antisense RNA,
microRNA, DNA, and gene editing therapeutics. Arcturus’
technologies are covered by its extensive patent portfolio (231
patents and patent applications, issued in the U.S., Europe, Japan,
China and other countries). Arcturus’ commitment to the development
of novel RNA therapeutics has led to collaborations with Janssen
Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies
of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda
Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics
Inc., Duke-NUS Medical School, and the Cystic Fibrosis Foundation.
For more information visit www.ArcturusRx.com. In addition, please
connect with us on Twitter and LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. Any statements, other than statements of historical
fact included in this press release, are forward-looking
statements, including those regarding strategy, future operations,
collaborations, the likelihood of success (including safety and
efficacy) of the Company’s pipeline (including ARCT-154), the
Company’s efforts to develop a vaccine against COVID-19 and
therapeutic potential thereof based on the Company’s mRNA
therapeutics, the planned initiation, design or completion of
clinical trials, the likelihood that the Company will obtain
clearance from regulatory authorities to proceed with future
planned clinical trials, the likelihood that preclinical or
clinical data will be predictive of future clinical results
(including with respect to safety, immunogenicity and efficacy),
the ability to enroll, and timing for enrollment of, subjects in
clinical trials, the timing and nature of any study results, the
likelihood that clinical data will be sufficient for regulatory
approval or completed in time to submit an application for
regulatory approval within a particular timeframe, the likelihood
or timing of any regulatory approval, the likelihood that a patent
will issue from any patent application, its current cash position
and expected cash burn and the impact of general business and
economic conditions. Actual results and performance could differ
materially from those projected in any forward-looking statements
as a result of many factors including, without limitation, the
ability to enroll subjects in clinical trials as a result of the
COVID-19 pandemic, the impact of commercialization of third-party
COVID-19 vaccines on the design, and ability to conduct, clinical
trials, the availability of manufacturing capacity and raw
materials, unexpected clinical results, government regulations
impacting the regulatory environment or intellectual property
landscape, and general market conditions that may prevent such
achievements or performance. Arcturus may not actually achieve the
plans, carry out the intentions or meet the expectations or
projections disclosed in any forward-looking statements such as the
foregoing and you should not place undue reliance on such
forward-looking statements. Such statements are based on
management’s current expectations and involve risks and
uncertainties, including those discussed under the heading "Risk
Factors" in Arcturus’ Annual Report on Form 10-K for the fiscal
year ended December 31, 2020, and in subsequent filings with, or
submissions to, the SEC. Except as otherwise required by law,
Arcturus disclaims any intention or obligation to update or revise
any forward-looking statements, which speak only as of the date
they were made, whether as a result of new information, future
events or circumstances or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20210922005480/en/
IR and Media Contacts Arcturus Therapeutics Neda
Safarzadeh (858) 900-2682 IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008
ctanzi@kendallir.com
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