Rockwell Medical Receives Important Feedback from FDA on its IND Application for Phase 2 Trial of Ferric Pyrophosphate Citrate in Home Infusion
15 December 2021 - 1:00AM
Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical
company dedicated to transforming the treatment of iron deficiency
and anemia management and improving outcomes for patients around
the world, today announced that it received feedback from the U.S.
Food and Drug Administration (FDA) regarding its Investigational
New Drug (IND) application in support of its proposed Phase 2
clinical trial of Ferric Pyrophosphate Citrate (FPC), designed for
the treatment of iron deficiency anemia and maintenance of
hemoglobin in patients receiving infusion therapy in the home
setting.
“We are breaking new ground with this study,
which is the first of its kind, evaluating the use of parenteral
iron in treating iron deficiency anemia in the rapidly-growing home
infusion setting. The study proposal includes a novel dosing
regimen, one that is fine-tuned to match the preferences of
caregivers and patients receiving health care at home. We are
working closely with FDA to ensure that our planned approach is
well suited for this patient population,” said Russell Ellison,
M.D., President and Chief Executive Officer of Rockwell
Medical.
FDA requested that additional data related to
the microbiology and short-term stability of FPC be submitted to
further support the drug administration method proposed for the
study. The company expects to run these additional studies,
complete the required analysis, and provide the requested data in
the first half of 2022. “We have a clear understanding of the
request from FDA, and we believe there is a well-defined path
forward to generate the data. The effort will help us refine our
study approach, which is carefully designed for the home infusion
application. We expect that these activities will have a minimal
impact on the timing of our planned dosing of the first patient in
this study,” said Marc Hoffman, M.D., Chief Medical Officer of
Rockwell Medical.
“This important feedback from FDA strengthens
our confidence in the potential value of this therapy. We are
working to ensure that this product is studied with the patient and
caregiver preferences in mind. The ultimate success of our project
would mean patients will have access to a treatment for iron
deficiency anemia in the home, so they could potentially avoid
visits to an office or clinic to receive iron. We believe this may
be a significant advance in the care of chronically ill patients
with iron deficiency anemia who wish to avoid visits to healthcare
facilities and the associated risks,” said Dr. Ellison.
Once the additional data is submitted, Rockwell
must wait 30 calendar days before treating any patients in the
clinical trial. During this time, FDA has an opportunity to review
the IND and the additional data that is submitted.
About Rockwell Medical
Rockwell Medical is a commercial-stage
biopharmaceutical company developing and commercializing its
next-generation parenteral iron technology platform, Ferric
Pyrophosphate Citrate (FPC), which has the potential to lead
transformative treatments for iron deficiency in multiple disease
states, reduce healthcare costs and improve patients’ lives. The
Company has two FDA-approved therapies indicated for patients
undergoing hemodialysis, which are the first two products developed
from the FPC platform. Rockwell Medical is also advancing its FPC
platform by developing FPC for the treatment of iron deficiency
anemia in patients outside of dialysis, who are receiving
intravenous medications in the home infusion setting. In addition,
Rockwell Medical is one of two major suppliers of life-saving
hemodialysis concentrate products to kidney dialysis clinics in the
United States. For more information, visit www.RockwellMed.com.
Rockwell Medical Forward-Looking
Statements
Certain statements in this press release,
including without limitation statements relating to the timing of
completion of response activities, the impact of the response
activities on the timing of dosing the first patient in the trial
and the path forward to resolve the FDA’s questions, may constitute
“forward-looking statements” within the meaning of the federal
securities laws. Words such as, “may,” “might,” “will,” “should,”
“believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,”
“can,” “would,” “develop,” “plan,” “potential,” “predict,”
“forecast,” “project,” “intend” or the negative of these terms, and
similar expressions, or statements regarding intent, belief, or
current expectations, are forward looking statements. While
Rockwell Medical believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such
forward-looking statements, which are based on information
available to us on the date of this release. These forward-looking
statements are based upon current estimates and assumptions and are
subject to various risks and uncertainties (including, without
limitation, those set forth in Rockwell Medical’s SEC filings),
many of which are beyond our control and subject to change. Actual
results could be materially different. Risks and uncertainties
include, but are not limited to: Rockwell’s ability to timely lift
the clinical hold for the planned home infusion trial, the impact
of the COVID-19 pandemic on Rockwell’s business, including any
clinical trials, and the FDA’s response time, the risks of current
treatment patterns in the home infusion setting for iron deficiency
anemia and whether the FDA will raise any additional issues with
the IND during its review period; and those risks more fully
discussed in the “Risk Factors” section of our Quarterly Report on
Form 10-Q for the period ended September 30, 2021 and of our Annual
Report on Form 10-K for the year ended December 31, 2020, as such
description may be amended or updated in any future reports we file
with the SEC. Rockwell Medical expressly disclaims any obligation
to update our forward-looking statements, except as may be required
by law.
ROCKWELL MEDICAL CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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