Rallybio to Present Results of Epidemiological Analysis Demonstrating FNAIT Risk Across Racially and Ethnically Diverse Populations at the NORD Breakthrough Summit
10 Septembre 2024 - 2:00PM
Business Wire
Rallybio Corporation (Nasdaq: RLYB), a clinical-stage
biotechnology company translating scientific advances into
transformative therapies for patients with devastating rare
diseases, announced today that full data from an epidemiological
analysis quantifying the proportion of women across diverse
populations at higher risk of a fetal and neonatal alloimmune
thrombocytopenia (FNAIT)-impacted pregnancy will be presented at
the NORD Rare Diseases & Orphan Products Breakthrough Summit to
be held October 20 – 22, 2024 in Washington DC.
“Consistent with the NORD Summit theme of ‘Equitable Access to
Innovation,’ our epidemiological analysis is particularly
pertinent, providing the first clear evidence of the extent to
which non-Caucasian populations can carry a higher risk for FNAIT,”
said Stephen Uden, M.D., Chief Executive Officer of Rallybio. “We
look forward to sharing this data and its implications at the
upcoming conference.”
The poster will be available in the Publications &
Presentations section of Rallybio’s website following the
conclusion of the conference. More information on the NORD Rare
Diseases & Orphan Products Breakthrough Summit can be found
here.
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 publications relating to FNAIT
and RLYB212, our estimates of the extent to which non-Caucasian
populations carry a higher risk for FNAIT, and the potential
success of our pipeline. 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/20240909604044/en/
Investor Samantha Tracy Rallybio Corporation (475)
47-RALLY (Ext. 282) investors@rallybio.com
Kevin Lui Precision AQ (212) 698-8691
kevin.lui@precisionaq.com
Media Victoria Reynolds Mission North (760) 579-2134
rallybio@missionnorth.com
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