STATISTICALLY SIGNIFICANT IMPROVEMENT IN
KIDNEY FUNCTION OBSERVED IN PATIENTS WITH FOCAL SEGMENTAL
GLOMERULOSCLEROSIS AFTER 12 WEEKS OF TREATMENT
Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage
biopharmaceutical company, today announced positive, final results
from the focal segmental glomerulosclerosis (FSGS) cohort of
PHOENIX, a Phase 2 study of bardoxolone methyl (bardoxolone) in
patients with rare forms of chronic kidney disease (CKD).
Compared to baseline, bardoxolone significantly improved kidney
function as measured by patients’ estimated glomerular filtration
rate (eGFR) at Week 12, which was the primary endpoint of the
PHOENIX study.
Patients treated with bardoxolone experienced a
significant increase in eGFR of 7.8 mL/min/1.73 m2 (n=18; p=0.003)
at Week 12 compared to baseline. Reata collected historical
eGFR data for 17 of the 18 patients, which demonstrated that these
patients’ kidney function was declining at an average annual rate
of 2.6 mL/min/1.73 m2 prior to study entry. The observed 7.8
mL/min/1.73 m2 improvement after 12 weeks of treatment with
bardoxolone represents a recovery of three years of average eGFR
loss. With respect to safety, no treatment-related serious
adverse events were reported, and the reported adverse events were
generally mild to moderate in intensity.
Overall, the PHOENIX trial studied 103 patients
who had one of four rare forms of CKD, including autosomal dominant
polycystic kidney disease (ADPKD) (n=31), IgA nephropathy (n=26),
type 1 diabetic CKD (n=28), and FSGS (n=18). Historical eGFR
data collected from 91 of the 103 patients demonstrated that these
patients’ kidney function was declining at an average annual rate
of 2.8 mL/min/1.73 m2 prior to study entry. After 12 weeks of
once-daily, oral administration of bardoxolone, the mean change in
eGFR from baseline across all four cohorts was 7.8 mL/min/1.73 m2
(n=103; p<0.00001). Notably, 88% of patients who reached
Week 12 demonstrated an improvement in eGFR. Bardoxolone
significantly reduced mean systolic blood pressure by 3.8 mmHg
(n=103; p=0.002) and mean diastolic blood pressure by 2.8 mmHg
(n=103; p=0.0009). Urinary albumin excretion was low upon
study entry and remained unchanged by bardoxolone treatment (n=103;
p=0.6). Bardoxolone was well-tolerated, with 89% of patients
in PHOENIX completing treatment through Week 12, and no
treatment-related serious adverse events were reported.
“In studies to date, bardoxolone has
significantly improved kidney function in a high proportion of
patients across six distinct forms of CKD. This supports the
hypothesis that bardoxolone addresses a final common pathway of CKD
progression,” said Colin Meyer, M.D., Reata’s Chief Medical
Officer. “Additionally, in PHOENIX, bardoxolone treatment was
well tolerated, did not increase proteinuria, and significantly
reduced blood pressure. In three prior longer-term trials,
bardoxolone treatment produced eGFR improvements that were
maintained for at least one year and were associated with a
retained eGFR benefit after drug withdrawal. We believe that
these clinical data suggest that bardoxolone treatment may prevent
or delay kidney failure and the need for dialysis or a kidney
transplant in many forms of CKD.”
Reata management will host a conference call and
webcast to discuss these results on Wednesday, February 20, 2019,
at 8:00 a.m. ET at the following:
CONFERENCE CALL
INFORMATION |
Date: |
Wednesday, February 20, 2019 |
Time: |
8:00
a.m. ET |
Audience
Dial-in (toll-free): |
(844)
348-3946 |
Audience
Dial-in (international): |
(213)
358-0892 |
Conference ID: |
6555059 |
Webcast
Link: |
https://edge.media-server.com/m6/p/pcxmgtgj |
|
|
About the PHOENIX Study
The Phase 2 PHOENIX program studied bardoxolone
in patients with ADPKD, IgA nephropathy, FSGS, and type 1 diabetic
CKD. Patients received bardoxolone open-label, orally, once
daily for 12 weeks, and the primary efficacy endpoint was change
from baseline in eGFR after 12 weeks of treatment. Endpoints
were assessed for each cohort separately. PHOENIX is
complete, and results from all four cohorts have now been
released.
About Focal Segmental
Glomerulosclerosis
FSGS is a rare form of CKD that is characterized
by progressive scarring of kidney glomeruli in a focal and
segmental pattern, such that not all glomeruli (focal) and only a
part of the glomerular tuft (segmental) are affected.
Abnormal leakage of proteins through the glomerular basement
membrane (GBM) and excessive reabsorption of protein in the
proximal tubules of the kidney induce oxidative stress, chronic
inflammation, fibrosis, and loss of kidney function. FSGS is
one of the most common primary glomerular disorders causing
end-stage renal disease and affects approximately 40,000 people in
the United States. There are currently no U.S. Food and Drug
Administration (FDA)-approved therapies for FSGS.
About Bardoxolone Methyl
Bardoxolone is an experimental, oral, once-daily
activator of Nrf2, a transcription factor that induces molecular
pathways that promote the resolution of inflammation by restoring
mitochondrial function, reducing oxidative stress, and inhibiting
pro-inflammatory signaling. The FDA has granted Orphan Drug
designation to bardoxolone for the treatment of Alport syndrome and
pulmonary arterial hypertension. The European Commission has
granted Orphan Drug designation in Europe to bardoxolone for the
treatment of Alport syndrome. Bardoxolone is currently being
studied in CARDINAL, a Phase 3 study for the treatment of Alport
syndrome, CATALYST, a Phase 3 study for the treatment of connective
tissue disease-associated pulmonary arterial hypertension, and
AYAME, a Phase 3 study for the treatment of diabetic kidney disease
in Japan. AYAME is being conducted by our licensee Kyowa
Hakko Kirin Co., Ltd.
About Reata Pharmaceuticals,
Inc.
Reata is a clinical-stage biopharmaceutical
company that develops novel therapeutics for patients with serious
or life-threatening diseases by targeting molecular pathways
involved in the regulation of cellular metabolism and inflammation.
Reata’s two most advanced clinical candidates, bardoxolone
and omaveloxolone, target the important transcription factor Nrf2
that promotes the resolution of inflammation by restoring
mitochondrial function, reducing oxidative stress, and inhibiting
pro-inflammatory signaling.
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements,” including, without
limitation, statements regarding the success, cost and timing of
our product development activities and clinical trials, our plans
to research, develop and commercialize our product candidates, and
our ability to obtain and retain regulatory approval of our product
candidates. You can identify forward-looking statements
because they contain words such as “believes,” “will,” “may,”
“aims,” “plans,” and “expects.” Forward-looking statements
are based on Reata’s current expectations and assumptions.
Because forward-looking statements relate to the future, they are
subject to inherent uncertainties, risks, and changes in
circumstances that may differ materially from those contemplated by
the forward-looking statements, which are neither statements of
historical fact nor guarantees or assurances of future
performance. Important factors that could cause actual
results to differ materially from those in the forward-looking
statements include, but are not limited to; (i) the timing, costs,
conduct, and outcome of our clinical trials and future preclinical
studies and clinical trials, including the timing of the initiation
and availability of data from such trials; (ii) the timing and
likelihood of regulatory filings and approvals for our product
candidates; (iii) the potential market size and the size of the
patient populations for our product candidates, if approved for
commercial use, and the market opportunities for our product
candidates; and (iv) other factors set forth in Reata’s filings
with the U.S. Securities and Exchange Commission, including its
Annual Report on Form 10-K, under the caption “Risk Factors.”
The forward-looking statements speak only as of the date made and,
other than as required by law, we undertake no obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events, or otherwise.
Contact:Reata Pharmaceuticals, Inc.(972)
865-2219info@reatapharma.comhttp://news.reatapharma.com
Investor Relations:Vinny JindalVice President,
Strategy(469) 374-8721ir@reatapharma.com
Media:Matt Middleman, M.D.LifeSci Public
Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
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