— First Ever Trial in Pregnant Women at Higher
Risk of Alloimmunization and FNAIT —
— Screening in the Phase 2 Clinical Trial On
Track to Initiate in 4Q 2024 —
Rallybio Corporation (Nasdaq: RLYB), a clinical-stage
biotechnology company translating scientific advances into
transformative therapies for patients with devastating rare
diseases, today announced the approval of its clinical trial
applications (CTAs) for a Phase 2 clinical trial of RLYB212 in
pregnant women at higher risk for HPA-1a alloimmunization and fetal
and neonatal alloimmune thrombocytopenia (FNAIT). With these
approvals from the European Medicines Agency (EMA) and the United
Kingdom’s Medicines and Healthcare products Regulatory Agency
(MHRA), Rallybio will begin to activate Phase 2 clinical sites and
expects to initiate screening of participants in the fourth quarter
of 2024.
“Securing these CTA approvals from European health authorities
to advance RLYB212 into a Phase 2 trial is a significant
achievement. These approvals are a testament to the dedication and
innovation of our team and our partners as we advance this first
ever program to prevent maternal alloimmunization and FNAIT,” said
Stephen Uden, M.D., Chief Executive Officer of Rallybio. “We are
activating clinical sites and expect to initiate screening this
quarter, which will mark another important step toward achieving
our mission to prevent FNAIT and its potentially devastating
consequences.”
The single-arm Phase 2 dose confirmation trial
(2024-512651-20/NCT06435845) will be conducted in Belgium, the
Netherlands, Norway, Sweden, and the UK, and is designed to assess
the pharmacokinetics (PK) and safety of RLYB212, a monoclonal
anti-HPA-1a antibody, in a total of eight pregnant women at higher
risk for HPA-1a alloimmunization and FNAIT. Secondary objectives
include assessments of pregnancy and neonatal/infant outcomes, and
the occurrence of emergent HPA-1a alloimmunization. Subcutaneous
administration of RLYB212 will be initiated by Gestational Week 16
and will continue every 4 weeks through parturition.
“These approvals recognize Rallybio’s commitment to safely and
effectively progress a novel prophylactic approach for preventing
alloimmunization in pregnant women at higher FNAIT risk,” said
Steven Ryder, M.D., Chief Medical Officer at Rallybio. “We are
proud to be leaders in bringing much needed innovation to this area
of women’s health, which has gone unaddressed for far too
long.”
About FNAIT
Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) is a
potentially life-threatening rare disease that can cause
uncontrolled bleeding in fetuses and newborns. FNAIT can arise
during pregnancy due to an immune incompatibility between an
expectant mother and her fetus in a specific platelet antigen
called human platelet antigen 1, or HPA-1.
There are two predominant forms of HPA-1, known as HPA-1a and
HPA-1b, which are expressed on the surface of platelets.
Individuals who are homozygous for HPA-1b, meaning that they have
two copies of the HPA-1b allele and no copies of the HPA-1a allele,
are also known as HPA-1a negative. Upon exposure to the HPA-1a
antigen, these individuals can develop antibodies to that antigen
in a process known as alloimmunization. In HPA-1a-negative
expectant mothers bearing a HPA-1a-positive fetus, alloimmunization
can occur upon mixing of fetal blood with maternal blood. When
alloimmunization occurs in an expectant mother, the anti-HPA-1a
antibodies that develop in the mother can cross the placenta and
destroy platelets in the fetus. The destruction of platelets in the
fetus can result in severely low platelet counts, or
thrombocytopenia, and potentially lead to devastating consequences
including miscarriage, stillbirth, death of the newborn, or severe
lifelong neurological disability in those babies who survive. There
is currently no approved therapy for the prevention or prenatal
treatment of FNAIT.
About Rallybio
Rallybio (NASDAQ: RLYB) is a clinical-stage biotechnology
company with a mission to develop and commercialize
life-transforming therapies for patients with severe and rare
diseases. Rallybio has built a broad pipeline of promising product
candidates aimed at addressing diseases with unmet medical need in
areas of maternal fetal health, complement dysregulation,
hematology, and metabolic disorders. The Company has two clinical
stage programs: RLYB212, an anti-HPA-1a antibody for the prevention
of fetal and neonatal alloimmune thrombocytopenia (FNAIT) and
RLYB116, an inhibitor of complement component 5 (C5), with the
potential to treat several diseases of complement dysregulation, as
well as additional programs in preclinical development. Rallybio is
headquartered in New Haven, Connecticut. For more information,
please visit www.rallybio.com and follow us on LinkedIn and
Twitter.
Forward-Looking Statements
This press release contains forward-looking statements that are
based on our management’s beliefs and assumptions and on currently
available information. All statements, other than statements of
historical facts contained in this press release are
forward-looking statements. In some cases, forward-looking
statements can be identified by terms such as “may,” “will,”
“should,” “expect,” “plan,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplate,” “believe,” “estimate,”
“predict,” “potential” or “continue” or the negative of these terms
or other similar expressions, although not all forward-looking
statements contain these words. Forward-looking statements in this
press release include, but are not limited to, statements
concerning the timing of activating sites and initiating screening
for the Phase 2 RLYB212 clinical trial, and statements concerning
Rallybio’s ability to successfully complete the Phase 2 trial,
advance to a Phase 3 trial and obtain marketing approval of
RLYB212. The forward-looking statements in this press release are
only predictions and are based largely on management’s current
expectations and projections about future events and financial
trends that management believes may affect Rallybio’s business,
financial condition and results of operations. These
forward-looking statements speak only as of the date of this press
release and are subject to a number of known and unknown risks,
uncertainties and assumptions, including, but not limited to, our
ability to successfully initiate and conduct our planned clinical
trials, including the FNAIT natural history study, and the Phase 2
clinical trial for RLYB212, and complete such clinical trials and
obtain results on our expected timelines, or at all, whether our
cash resources will be sufficient to fund our operating expenses
and capital expenditure requirements and whether we will be
successful raising additional capital, our ability to enter into
strategic partnerships or other arrangements, competition from
other biotechnology and pharmaceutical companies, and those risks
and uncertainties described in Rallybio’s filings with the U.S.
Securities and Exchange Commission (SEC), including Rallybio’s
Quarterly Report on Form 10-Q for the period ended June 30, 2024,
and subsequent filings with the SEC. The events and circumstances
reflected in our forward-looking statements may not be achieved or
occur and actual future results, levels of activity, performance
and events and circumstances could differ materially from those
projected in the forward-looking statements. Except as required by
applicable law, we are not obligated to publicly update or revise
any forward-looking statements contained in this press release,
whether as a result of any new information, future events, changed
circumstances or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20241028492736/en/
Investor Contacts Samantha Tracy Rallybio Corporation
(475) 47-RALLY (Ext. 282) investors@rallybio.com
Kevin Lui Precision AQ (212) 698-8691
kevin.lui@precisionaq.com
Media Contact Victoria Reynolds Mission North (760)
579-2134 rallybio@missionnorth.com
Rallybio (NASDAQ:RLYB)
過去 株価チャート
から 12 2024 まで 1 2025
Rallybio (NASDAQ:RLYB)
過去 株価チャート
から 1 2024 まで 1 2025
