Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the
“Company”), a clinical-stage biopharmaceutical company focused on
rare diseases, today provided an update on recent program
developments and third quarter 2023 financial information.
Recent Program Developments
Setrusumab (UX143)
On October 14, 2023, Ultragenyx Pharmaceutical Inc. (NASDAQ:
RARE) and Mereo BioPharma Group plc (“Mereo” or the “Company”)
announced interim data from the Phase 2 portion of the Phase 2/3
Orbit study demonstrating that treatment with setrusumab (UX143)
achieved a 67% reduction in annualized fracture rate in patients
with osteogenesis imperfecta (OI) with at least 6 months of
follow-up and continues to demonstrate ongoing and meaningful
improvements in lumbar spine bone mineral density (BMD). The Phase
3 portion of the study is currently enrolling approximately 195
patients at 50 sites across 12 countries.
Alvelestat (MPH-966)
University of Alabama at Birmingham (UAB) and the Company are
reporting on the ATALANTa study, a multi-center, double-blind,
placebo-controlled, proof-of-concept investigator-led study run by
Professor Mark Dransfield, Director of the Division of Pulmonary,
Allergy and Critical Care, UAB, in collaboration with Mereo.
ATALANta investigated the safety and efficacy of alvelestat 120 mg,
or matched placebo, twice daily, for 12 weeks in a broad range of
individuals with Alpha-1 Antitrypsin Deficiency-Associated Lung
Disease, including subjects with less severe phenotypes (Pi*SZ)
than were enrolled in the Company-sponsored ASTRAEUS Phase 2 study,
and those receiving augmentation therapy. The study randomized 63
patients, 32 in the 120 mg alvelestat arm (44% on augmentation
therapy) and 31 in the placebo arm (48% on augmentation
therapy).
The results demonstrated with the 120 mg dose of alvelestat (the
lower dose used in the Phase 2 ASTRAEUS study) are consistent with
those observed in ASTRAEUS on blood neutrophil elastase activity
and changes in the biomarkers desmosine and Aα-val360. The data
from ATALANTa also show the significant effect of alvelestat on the
SGRQ-activity domain in patients not on augmentation (p=0.0106
versus placebo).
There was no difference in the proportion of patients with
treatment-related Adverse Events (AEs) between the alvelestat and
placebo arms. There were no Serious Adverse Events (SAEs) and no
Adverse Events of Special interest (AESIs) of liver, QTC
prolongation or neutropenia observed. AESIs of infection were more
frequent in the placebo arm, driven by an increased number of acute
exacerbations of COPD (one in the alvelestat arm in a patient on
augmentation, and seven exacerbations in the placebo arm in seven
patients, five of whom were on augmentation). There were two
discontinuations in the alvelestat group due to mild and moderate
headache. The data demonstrate that the 120 mg dose of alvelestat
is safe on top of augmentation and support Mereo’s selection of the
240 mg dose to be studied in the planned Phase 3 pivotal trial.
Additional data are expected to be presented by UAB at future
medical conferences.
The ATALANTa study was funded by the National Center for
Advancing Translational Sciences (NCATS) through the National
Institutes of Health (NIH)-Industry Program for discovering new
therapeutic uses for existing molecules.
In Europe, the Company has received guidance from the European
Medicines Agency (EMA) that a Phase 3 primary endpoint of lung
density by computed tomography (CT) scan with a relaxed p value
(p<0.1) may, if the study is successful, be sufficient for full
approval. In the US, the Company is continuing its interactions
with the FDA and the Division of Clinical Outcomes Assessment
(DCOA) regarding the use of a Patient Reported Outcome (PRO) as a
primary Phase 3 endpoint.
The data from the ATALANTa study are expected to further support
the ongoing partnering process for the alvelestat Phase 3
program.
Etigilimab (MPH-313)
On October 21, 2023, an update on the Company’s Phase 1b/2 study
investigating the safety and efficacy of etigilimab (anti-TIGIT) in
combination with nivolumab (anti-PD1) in recurrent/advanced solid
tumors (ACTIVATE) was presented in a mini-oral session at the ESMO
2023 Congress in Madrid, Spain by Dr. Meredith McKean, Sarah Cannon
Research Institute, USA. Of 40 evaluable patients presented in
select cohorts, three complete responses (CRs), seven partial
responses (PRs) and eleven stable disease (SDs) beyond 112 days
(3.7 months) were noted. Seven patients showed clinical benefit for
≥ 335 days (11 months). The data show promising efficacy in PDL1
low patients with six of seven on study ≥ 335 days (11 months)
being PDL1 negative or low and all having high PVR tumoral
expression. Etigilimab in combination with nivolumab continues to
be safe and well tolerated with no new safety signals noted. The
last patient last dose was completed at the end of June 2023. The
cervical cancer and uveal melanoma cohorts cleared the protocol
Simon 2 Stage design interim futility monitoring bar for expansion
to Stage 2 and were endorsed by an independent data monitoring
committee for expansion.
Etigilimab, in combination with nivolumab, is in an ongoing
investigator-led single-arm, two-stage, open-label Phase 1b/2 trial
in a subtype of platinum-resistant recurrent ovarian cancer (clear
cell ovarian cancer) at The University of Texas MD Anderson Cancer
Center, financed by the Cancer Focus Fund. This trial is being led
by Dr. Shannon Westin. Enrollment is currently being expanded from
the initial 10 patients to 20 patients.
The Company continues to seek a partner for further development
of etigilimab.
Third Quarter 2023 Financial Information
As of September 30, 2023, the Company had cash and short-term
deposits of £51.2 million ($62.4 million). Cash and short-term
deposits, net of expenditures, increased by £9.1 million ($11.1
million) during the third quarter of 2023.
In July 2023, the Company received a $9.0 million (£7.1 million)
milestone payment from its partner, Ultragenyx, and gross proceeds
of $12.0 million (£9.3 million) from the issuance of 9,673,419 ADSs
representing 48,367,095 ordinary shares through an “at-the-market”
offering pursuant to its Open Market Sale Agreement with Jefferies
LLC. The Company expects its existing cash and short-term deposits,
excluding income from existing or potential partnerships, will
enable it to fund its currently committed clinical trials,
operating expenses and capital expenditure requirements into
2026.
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the
development of innovative therapeutics for rare diseases. The
Company has two rare disease product candidates, setrusumab for the
treatment of Osteogenesis Imperfecta (OI) and alvelestat primarily
for the treatment of severe alpha-1-antitrypsin
deficiency-associated lung disease (AATD-LD). The Company’s
partner, Ultragenyx Pharmaceutical, Inc., has initiated a pivotal
Phase 2/3 pediatric study in young adults (5 to <26 years old)
for setrusumab in OI and a Phase 3 study in pediatric patients (2
to <7 years old) in the first half of 2023. The partnership with
Ultragenyx includes potential milestone payments of up to $245
million (following the recent $9 million milestone) and royalties
to Mereo on commercial sales in Ultragenyx territories. Mereo has
retained EU and UK commercial rights and will pay Ultragenyx
royalties on commercial sales in those territories. Setrusumab has
received orphan designation for OI from the EMA and FDA, PRIME
designation from the EMA and has pediatric disease designation from
the FDA. Alvelestat has received U.S. Orphan Drug Designation for
the treatment of AATD, Fast Track designation from the FDA, and
positive data were reported from a Phase 2 proof-of-concept study
in North America, Europe and the UK. In addition to the rare
disease programs, Mereo has two oncology product candidates in
clinical development. Etigilimab (anti-TIGIT) has completed
enrollment in a Phase 1b/2 basket study evaluating its safety and
efficacy in combination with an anti-PD-1 in a range of tumor types
including three rare tumors and three gynecological carcinomas -
cervical, ovarian, and endometrial and is in an ongoing Phase 1b/2
investigator led study at the MD Anderson Cancer Center in clear
cell ovarian cancer; navicixizumab, for the treatment of late line
ovarian cancer, has completed a Phase 1 study and has been
partnered with OncXerna Therapeutics, Inc. in a global licensing
agreement that includes payments of up to $300 million in
milestones and royalties.
For more information on Mereo BioPharma, please visit
www.mereobiopharma.com.
Forward-Looking Statements
This press release contains “forward-looking statements.” All
statements other than statements of historical fact contained
herein are forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended (the “Securities
Act”), and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). Forward-looking statements usually
relate to future events and anticipated revenues, earnings, cash
flows or other aspects of our operations or operating results.
Forward-looking statements are often identified by the words
“believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,”
“should,” “would,” “could,” “may,” “estimate,” “outlook” and
similar expressions, including the negative thereof. The absence of
these words, however, does not mean that the statements are not
forward-looking. These forward-looking statements are based on the
Company’s current expectations, beliefs and assumptions concerning
future developments and business conditions and their potential
effect on the Company. While management believes that these
forward-looking statements are reasonable as and when made, there
can be no assurance that future developments affecting the Company
will be those that it anticipates.
All of the Company’s forward-looking statements involve known
and unknown risks and uncertainties some of which are significant
or beyond its control and assumptions that could cause actual
results to differ materially from the Company’s historical
experience and its present expectations or projections. Such risks
and uncertainties include, among others, the uncertainties inherent
in the clinical development process; the Company’s reliance on
third parties to conduct and provide funding for its clinical
trials; the Company’s dependence on enrollment of patients in its
clinical trials; and the Company’s dependence on its key
executives. You should carefully consider the foregoing factors and
the other risks and uncertainties that affect the Company’s
business, including those described in the “Risk Factors” section
of its latest Annual Report on Form 20-F, reports on Form 6-K and
other documents furnished or filed from time to time by the Company
with the Securities and Exchange Commission. The Company wishes to
caution you not to place undue reliance on any forward-looking
statements, which speak only as of the date hereof. The Company
undertakes no obligation to publicly update or revise any of our
forward-looking statements after the date they are made, whether as
a result of new information, future events or otherwise, except to
the extent required by law.
Mereo BioPharma
Contacts: |
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Mereo |
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+44 (0)333 023
7300 |
Denise Scots-Knight, Chief
Executive Officer |
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Christine Fox, Chief Financial
Officer |
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Burns McClellan
(Investor Relations Adviser to Mereo) |
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+01 646 930
4406 |
Lee Roth |
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Investors |
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investors@mereobiopharma.com |
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