SOUTH SAN FRANCISCO, Calif.,
Sept. 1, 2021 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced
the publication of results from a Phase 2 clinical trial evaluating
the safety of fostamatinib for the treatment of hospitalized
patients with COVID-19, in Clinical Infectious Diseases, an
official publication of the Infectious Disease Society of America.
The study was sponsored by the National Heart, Lung, and Blood
Institute (NHLBI), part of the National Institutes of Health (NIH),
in collaboration with Inova Health System.
"As cases of COVID continue to surge across the world, improved
therapies for patients hospitalized with COVID-19 are urgently
needed," said Richard Childs, M.D.,
Clinical Director of the NHLBI at the NIH. "We are encouraged
to see that for COVID-19 patients requiring hospitalization,
fostamatinib in combination with the standard of care was shown to
be well tolerated in the study. Patients treated with fostamatinib
not only had less severe adverse events, but were observed to have
improved clinical outcomes compared to those receiving placebo and
standard of care."
The results from the 59 patient Phase 2 trial demonstrated that
the addition of fostamatinib to standard of care (SOC), which
included the antiviral remdesivir and the steroid dexamethasone,
was well tolerated and associated with clinically meaningful
improvement in clinical outcomes in hospitalized COVID-19 patients
who required supplemental oxygen. While the study was not powered
to test clinical efficacy, numerous prespecified secondary
endpoints consistently favored fostamatinib, including mortality,
time to sustained recovery, change in ordinal scale assessment,
number of days on oxygen, and number of days in the ICU, suggesting
that fostamatinib may provide an additional therapeutic benefit
compared to current SOC alone.
"It's reassuring to see that fostamatinib demonstrated a
consistently well-tolerated safety profile for hospitalized
patients with COVID-19 in this trial," said Jeffrey R. Strich,
M.D., principal investigator of the study and a physician
at the NIH Clinical Center. "Additional studies are needed to
confirm the efficacy findings and show how fostamatinib may address
the dysregulated immune response observed in COVID-19
patients."
Results were published online in a manuscript titled
"Fostamatinib for the treatment of hospitalized adults with
COVD-19, A randomized trial" and can be accessed here:
https://doi.org/10.1093/cid/ciab732.
Key findings within the fostamatinib Phase 2 trial include:
- The study met the primary endpoint showing fostamatinib did
not increase the incidence of serious adverse events (SAEs)
compared with placebo.
- The overall incidence of SAEs by Day 29 was approximately
50% less in the fostamatinib group (10.5%) compared with the
placebo group (22.0%) (p=0.2) . The most frequent SAE
reported by Day 29 was hypoxia, occurring in 1 patient receiving
fostamatinib and 3 patients receiving placebo.
- At Day 29, in the overall population there were zero deaths
in the fostamatinib group compared to 3 in the placebo group
(p=0.07). In more severe patients (ordinal scale 6 or 7), the
difference was 0/19 patients in the fostamatinib group compared to
3/17 patients in the placebo group (p=0.049).
- There were 4 intubated patients in the trial on mechanical
ventilation (ordinal scale 7) upon enrollment with 2 patients
randomized to each treatment group. Both patients in the
fostamatinib group were extubated and discharged from the hospital,
while both patients in the placebo group deceased.
- The median number of days in the ICU was reduced by 4 days,
from 7 days (IQR* 2-10) in the placebo group to 3 days (IQR 2-5) in
the fostamatinib group (p=0.07).
- The median number of days on oxygen was 8 (IQR 5-10) in the
fostamatinib group compared to 20 (IQR 14-27) in the placebo group
(p=0.2). The difference was even greater in more severe patients
with the fostamatinib group at 10 days compared to placebo at 28
days (p=0.027).
- At Day 15, 65.5% of patients were free of supplemental
oxygen in the fostamatinib group compared to 39.9% in the placebo
group (p=0.08). In more severe patients, the difference was 57.9%
compared to 20% (p=0.016).
- Fostamatinib was superior to placebo in accelerating
improvement in clinical status from baseline by Day 15 (mean change
-3.6 + 0.3 vs. -2.6 + 0.4; p=0.035) using ordinal scale
assessments.
- The median time to recovery was 8 days in both groups. The
greatest benefits were observed in more severe patients where the
median time to recovery was reduced from 13 days (IQR 11-19) in the
placebo group to 10 days (IQR 6-13) in the fostamatinib
group.
- Despite general SOC use of both steroids and remdesivir in
all 59 patients, there was a consistently greater reduction in
NETosis and other inflammatory biomarkers (CRP, Ferritin, D-Dimer,
Fibrinogen) in the fostamatinib group compared to the placebo
group.
*IQR = Interquartile Range, is the range of the first and
third quartiles of the range as a measure of spread.
"With the need remaining so great, we are very pleased with the
growing body of evidence that suggests fostamatinib may provide
clinical benefit for those patients hospitalized with COVID-19,"
said Raul Rodriguez, president and
CEO of Rigel. "Our larger Phase 3 clinical trial in COVID-19, which
we expect to complete later this year, will provide us with further
understanding of the safety and efficacy of fostamatinib and its
potential as a new therapy for these patients."
Phase 2 Clinical Trial Design
The Phase 2
double-blind, placebo-controlled clinical trial sponsored by the
NHLBI, part of the NIH, in collaboration with Inova Health System,
enrolled fifty-nine hospitalized patients with COVID-19 who were a
5 to 7 on the 8-point ordinal scale (requiring supplemental oxygen
via nasal cannula or non-invasive ventilation, requiring mechanical
ventilation or extracorporeal membrane oxygenation). Patients were
randomly assigned to one of two cohorts: fostamatinib plus SOC and
matched placebo plus SOC (1:1). Treatment was administered orally
twice daily for 14 days, with a follow-up period through day 60.
The primary outcome was the cumulative incidence of SAEs by Day 29.
Notably, all patients received dexamethasone (or other steroid) and
remdesivir.
About Clinical Infectious Diseases
Clinical Infectious Diseases is a leading journal in
the field of infectious diseases with a broad international
readership. The journal publishes articles on a variety of subjects
of interest to practitioners and researchers. Topics range from
clinical descriptions of infections, public health, microbiology,
and immunology to the prevention of infection, the evaluation of
current and novel treatments, and the promotion of optimal
practices for diagnosis and treatment. Clinical Infectious
Diseases is an official publication of the Infectious
Diseases Society of America. Learn more
at https://academic.oup.com/cid.
About Rigel
Rigel Pharmaceuticals, Inc., is a
biotechnology company dedicated to discovering, developing, and
providing novel small molecule drugs that significantly improve the
lives of patients with hematologic disorders, cancer, and rare
immune diseases. Rigel's pioneering research focuses on signaling
pathways that are critical to disease mechanisms. The company's
first FDA-approved product is
TAVALISSE® (fostamatinib disodium hexahydrate)
tablets, the only oral spleen tyrosine kinase (SYK) inhibitor for
the treatment of adult patients with chronic immune
thrombocytopenia who have had an insufficient response to a
previous treatment. The product is also commercially available in
Europe (TAVLESSE) and Canada (TAVALISSE) for the treatment of
chronic immune thrombocytopenia in adult patients.
Fostamatinib is currently being studied in a Phase 3 clinical
trial (NCT03764618) for the treatment of warm autoimmune hemolytic
anemia (wAIHA)1; a Phase 3 clinical trial (NCT04629703)
for the treatment of hospitalized high-risk patients with
mild-to-moderate COVID-191; an NIH/NHLBI-sponsored Phase
3 ACTIV-4 Host Tissue Study for the treatment of COVID-19 in
hospitalized patients on oxygen therapy, and a Phase 2 clinical
trial for the treatment of COVID-19 being conducted by Imperial
College London.
Rigel's other clinical programs include its interleukin
receptor-associated kinase (IRAK) inhibitor program, and a
receptor-interacting serine/threonine-protein kinase (RIP1)
inhibitor program in clinical development with partner Eli Lilly
and Company. In addition, Rigel has product candidates in
development with partners AstraZeneca, BerGenBio ASA, and Daiichi
Sankyo.
For further information, visit www.rigel.com or follow us on
Twitter or LinkedIn.
Please see www.TAVALISSEUSPI.com for the full
Prescribing Information.
1. The product for this use or indication is
investigational and has not been proven safe or effective by any
regulatory authority.
Forward Looking Statements
This press release and
other publicly available documents, including the documents
incorporated herein by reference, contain " forward-looking
statements" within the meaning of the safe harbor provisions of the
U.S. Private Securities Litigation Reform Act of 1995. Examples of
forward-looking statements include statements relating to, among
other things, the continuing need for therapies to treat the
health impacts and complications from COVID-19; the plans of Rigel
and other parties to complete further confirmatory studies of
fostamatinib's safety and efficacy in COVID-19 patients; and
Rigel's plans to seek regulatory and marketing approvals of
fostamatinib's use for treating COVID-19 patients. Forward-looking
statements can be identified by words such as "plan", "potential",
"may", "expects", "will" and similar expressions in reference to
future periods. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based
on Rigel's current beliefs, expectations, and assumptions regarding
the future of our business, future plans and strategies,
projections, anticipated events and trends, the economy and other
future conditions, and hence they inherently involve significant
risks, uncertainties and changes in circumstances that are
difficult to predict and many of which are outside of our
control. Therefore, you should not rely on any of these
forward-looking statements. Actual results and the timing of events
could differ materially from those anticipated in such forward
looking statements as a result of these risks and uncertainties,
which include, without limitation, risks and uncertainties
associated with whether there is an ongoing need for COVID-19
therapies; risks that the FDA, EMA or other regulatory authorities
may make adverse decisions regarding fostamatinib; risks that
fostamatinib clinical trials may not be predictive of real-world
results or of results in subsequent clinical trials; risks that
fostamatinib may have unintended side effects, adverse reactions or
incidents of misuses; the availability of resources to develop
Rigel's product candidates; market competition; as well as other
risks detailed from time to time in Rigel's reports filed with the
Securities and Exchange Commission, including its Quarterly Report
on Form 10-Q for the quarter ended June 30,
2021. Any forward-looking statement made by us in this press
release is based only on information currently available to
us and speaks only as of the date on which it is made. Rigel does
not undertake any obligation to update forward-looking statements,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise, and expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein.
Contacts:
For Investors
Jodi Sievers – Rigel Pharmaceuticals
Phone: 650.624.1232
Email: ir@rigel.com
For Media
Emily
Correia – Syneos Health
Phone: 508.314.3157
Email: emily.correia@syneoshealth.com
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SOURCE Rigel Pharmaceuticals, Inc.