Rallybio Presents Phase 1 Single Ascending Dose Data for RLYB116, an Innovative Subcutaneously Injected Inhibitor of Complement Component 5
2023年9月4日 - 1:00AM
ビジネスワイヤ(英語)
-- First-In-Human Single Ascending Dose
Clinical Data for RLYB116 Demonstrated a Reduction in Free C5
Greater than 99% at 24 Hours for the 100 mg dose and at 12, 24, and
72 Hours for the 300 mg dose in Healthy Participants --
-- Mean Estimated Elimination Half-Life for
RLYB116 was > 300 Hours --
-- No Severe or Serious Adverse Events with
Single-Dose Administration of RLYB116 --
-- Phase 1 Multiple Ascending Dose Study of
RLYB116 Ongoing; Preliminary Safety, PK, and PD Data Expected in 4Q
2023 --
Rallybio Corporation (Nasdaq: RLYB), a clinical-stage
biotechnology company committed to identifying and accelerating the
development of life-transforming therapies for patients with severe
and rare diseases, today presented clinical data in a poster from
the Phase 1 first-in-human single ascending dose (SAD) clinical
study in healthy participants of RLYB116. RLYB116 is an innovative
potentially long-acting, subcutaneously injected inhibitor of C5 in
development for the treatment of patients with complement-mediated
diseases. The poster presentation took place at the 29th
International Complement Workshop (ICW), in Newcastle, UK.
The data demonstrated that single-dose administration of RLYB116
at the two higher doses of 100 mg and 300 mg resulted in maximum
exposures of greater than 1 µM and 3 µM, respectively, and greater
than 99% reductions in free C5 concentrations. Subcutaneously
administered RLYB116 was observed to be generally well-tolerated as
a single 100 mg or 300 mg dose, with mild to moderate adverse
events and no drug-related serious adverse events.
“The results presented today at ICW continue to support our
belief in the potential use of RLYB116 for the treatment of a broad
range of complement-mediated diseases. These single-dose data
suggest that RLYB116 could be a highly innovative C5 inhibitor with
the potential to address significant unmet medical need for
patients,” commented Eric Watsky, M.D., Rallybio RLYB116 Program
Lead. “We remain on track to report initial data from the Phase 1
multiple ascending dose study of RLYB116 and disclosing our
indication strategy in the fourth quarter of 2023.”
The poster can be viewed on the Publications & Presentations
page of the company’s website:
https://rallybio.com/publications-presentations/
Additional information about ICW 2023 is available at:
https://icw2023newcastle.co.uk/.
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 results from the Phase 1 first-in-human single ascending
dose clinical study of RLYB116, and statements concerning the
expected progress, results and plans for RLYB116, the timing of the
availability of data from the Phase 1 multiple ascending dose (MAD)
study of RLYB116, our expectations regarding reporting of data from
the MAD study, our expectations regarding the usefulness of such
data and the data from the Phase 1 first-in-human single ascending
dose study, the timing of disclosure of our indication strategy for
RLYB116, and the likelihood that Rallybio will be successful in
developing RLYB116. 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 June 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/20230828368884/en/
Investors 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 Jorge Gaeta Mission North (516) 430-7659
Rallybio@missionnorth.com
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