-- Preliminary Data Support RLYB212 Once
Monthly Subcutaneous Dosing in Phase 2 Study --
-- RLYB212 Toxicology Package Complete,
Including Maternal-Fetal Toxicology; Key Activity to Support Phase
2 and Phase 3 Studies in Pregnant Women --
-- RLYB212 Phase 2 Study Expected To Commence
in 2H 2024 --
Rallybio Corporation (Nasdaq: RLYB) today announced preliminary
data from the completed multiple dose cohort of the Phase 1 safety
and pharmacokinetics (PK) study for RLYB212, an anti-HPA-1a
monoclonal antibody for the prevention of fetal and neonatal
alloimmune thrombocytopenia.
The Phase 1 multiple dose cohort for RLYB212 was initiated in
the first quarter of 2023 to evaluate the safety and PK of
subcutaneous (SC) RLYB212 based on repeat dosing over 12 weeks.
Eight HPA-1a negative subjects participated in the multiple dose
cohort; 6 subjects received RLYB212 every 2 weeks and 2 received
placebo every 2 weeks.
The preliminary data demonstrated that multiple dose PK were
consistent both within and between subjects. The preliminary data
and the Company’s clinical pharmacology modeling predictions
support a once monthly dosing regimen for the planned Phase 2
study. Consistent with previously reported data, RLYB212 was
observed to be generally well-tolerated with no reports of
injection site reactions or serious adverse events.
Rallybio also announced today that the RLYB212 toxicology
package to support the planned Phase 2 and Phase 3 studies,
including the maternal fetal toxicology program, is complete.
“These data support our belief in the potential use of
subcutaneous RLYB212 as a prophylactic therapeutic for the
prevention of HPA-1a alloimmunization and FNAIT,” commented Róisín
Armstrong, Ph.D., Rallybio’s RLYB212 Program Lead. “We are pleased
that the RLYB212 toxicology package is complete, including the
maternal fetal toxicology program. The program, which involved a
novel animal model, is a key step for Phase 2 and Phase 3 clinical
studies in pregnant women. We are now focused on initiating the
Phase 2 dose confirmation study in pregnant women at higher risk of
FNAIT in the second half of 2024. We thank all of our collaborators
and particularly, the Fraunhofer Institute for Translational
Medicine and Pharmacology and the German Red Cross, for their
support and partnership to complete the Phase 1 study.”
Rallybio expects to submit both the RLYB212 clinical
pharmacology model and the Phase 2 dosing approach, including
supportive clinical and nonclinical data, to a peer reviewed
journal in 2024.
About RLYB212 Phase 1 Safety and PK Study
Rallybio’s Phase 1 study is a single-blind, placebo-controlled
study that investigated the safety and PK of SC RLYB212 in HPA-1a
negative healthy participants. The study included two cohorts: a
previously completed single dose cohort and a multiple dose cohort.
In the multiple dose cohort, subjects received SC RLYB212 or
placebo every 2 weeks for 12 weeks.
The Phase 1 study was conducted at the Clinical Research
department of the Fraunhofer Institute for Translational Medicine
and Pharmacology ITMP, in Frankfurt/Main, Germany, in collaboration
with the Institute of Transfusion Medicine and Immunohaematology,
German Red Cross (Deutsches Rotes Kreuz) Blood Transfusion Service
Baden-Württemberg-Hessen gGmbH in Frankfurt/Main, Germany.
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 expectant mothers,
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 with an
additional facility at the University of Connecticut’s Technology
Incubation Program in Farmington, 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 preliminary multiple dose data from the Phase 1
safety and pharmacokinetics study for RLYB212, the expected dosing
regimen for the planned Phase 2 study, whether the completed
toxicology package for RLYB212 will be adequate to initiate the
planned Phase 2 study, statements concerning the substance, design
and timing of our planned or ongoing studies for RLYB212, including
the planned Phase 2 and Phase 3 studies, the timing of the
availability of data from such studies, our expectations regarding
the usefulness of such data, the success of modeling that informs
dosing for future studies, whether the RLYB212 clinical
pharmacology model and the Phase 2 dosing approach will be
published in a peer reviewed journal, our ability to advance
RLYB212 into future clinical studies, and the likelihood that
Rallybio will be successful in developing RLYB212 as an approach to
prevent FNAIT. 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
studies, and complete such clinical studies 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 September 30,
2023, 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/20231121254719/en/
Investor Contacts Ami Bavishi Head of Investor Relations
and Communications 475-47-RALLY (Ext. 282)
abavishi@rallybio.com
Hannah Deresiewicz Stern Investor Relations, Inc. 212-362-1200
hannah.deresiewicz@sternir.com
Media Contact Jorge Gaeta Mission North (516) 430-7659
Rallybio@missionnorth.com
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