Arix Bioscience PLC (ARIX) Arix Bioscience PLC: Clinical
development update from portfolio company LogicBio 02-Feb-2022 /
13:05 GMT/BST Dissemination of a Regulatory Announcement,
transmitted by EQS Group. The issuer is solely responsible for the
content of this announcement.
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Arix Bioscience plc
Clinical development update from portfolio company LogicBio
LONDON, 2 February 2021: Arix Bioscience plc ("Arix", LSE:ARIX),
a global venture capital company focused on investing in and
building breakthrough biotech companies, notes the update today
from its portfolio company, LogicBio Therapeutics, Inc. (Nasdaq:
LOGC) on its LB-001 clinical development programme.
LogicBio announced that the U.S. Food and Drug Administration
(FDA) has notified the company that its Phase 1/2 SUNRISE clinical
trial of LB-001 in paediatric patients with methylmalonic acidemia
(MMA) has been placed on clinical hold. The company will host a
conference call and webcast at 08:30 ET (13:30 GMT) to discuss the
update.
As of close of business on 1 February 2022 Arix held 2,716,211
shares in LogicBio.
The full announcement from LogicBio is set out below and can be
accessed here.
[ENDS]
For more information on Arix, please contact:
Arix Bioscience plc
+44 (0)20 7290 1050
ir@arixbioscience.com
Powerscourt Group
Sarah MacLeod, Ibrahim Khalil
+44 (0)20 7250 1446
arix@powerscourt-group.com
About Arix Bioscience plc
Arix Bioscience plc is a global venture capital company focused
on investing in and building breakthrough biotech companies around
cutting-edge advances in life sciences.
We collaborate with exceptional entrepreneurs and provide the
capital, expertise and global networks to help accelerate their
ideas into important new treatments for patients. As a listed
company, we are able to bring this exciting growth phase of our
industry to a broader range of investors.
www.arixbioscience.com
LogicBio Press Release
LogicBio Therapeutics Provides Update on LB-001 clinical
Development Program
- Company to host conference call and webcast today at 8:30 a.m.
ET
LEXINGTON, Mass., Feb. 2, 2022 /PRNewswire/ -- LogicBio
Therapeutics, Inc. (Nasdaq: LOGC), a clinical-stage genetic
medicine company, today provided an update on the LB-001 clinical
development program. The U.S. Food and Drug Administration (FDA)
has notified the company that its Phase 1/2 SUNRISE clinical trial
of LB-001 in pediatric patients with methylmalonic acidemia (MMA)
has been placed on clinical hold. The company will host a
conference call and webcast this morning to discuss this
update.
To date, four patients have been dosed in the SUNRISE trial with
LB-001, LogicBio's investigational, single-administration,
adeno-associated virus (AAV) genome editing therapy. In accordance
with the FDA-cleared protocol, the first two patients dosed were in
the older age group (3 to 12 years old) and received 5 x 1013 vg/kg
of LB-001. These first two patients are doing well, have not
experienced drug-related serious adverse events (SAEs), and are
being monitored in accordance with the protocol.
As previously disclosed, the third patient dosed in the SUNRISE
trial, who received 5 x 1013 vg/kg of LB-001 and is in the younger
age group (6 months to 2 years old), experienced a drug-related
SAE, which was categorized as a case of thrombotic microangiopathy
(TMA). TMA has been previously reported in association with other
AAV genetic therapies. The patient was hospitalized and responded
well to intravenous fluids and parenteral nutrition. Following this
SAE, the company implemented additional safety measures in the
SUNRISE trial, and reported the SAE to the FDA and the Data Safety
Monitoring Board for the trial (DSMB). In December 2021, the
company announced that the SAE experienced by the third patient had
resolved.
In January 2022, the fourth patient dosed in the SUNRISE trial,
who received 5 x 1013 vg/kg of LB-001 and is in the younger age
group, experienced a drug-related SAE, which was categorized as a
case of TMA. The patient is being closely followed by the patient's
care team and has been steadily improving. The company reported the
SAE to the FDA and the DSMB. The FDA subsequently notified the
company that the SUNRISE trial has been placed on clinical hold.
LogicBio will be working closely with the FDA and the DSMB to
determine the next steps for the SUNRISE trial and the LB-001
program.
"Patient safety is our first priority. I would like to thank the
patient and the patient's family for participating in our trial as
well as the on-site team for the excellent care they are
providing," said Fred Chereau, president and chief executive
officer of LogicBio. "We look forward to working closely with the
FDA and the DSMB to determine the next steps for the trial and the
program."
Until the company has more clarity regarding the impact of the
clinical hold, LogicBio is suspending guidance on the timing of
announcing interim data for the SUNRISE trial.
Conference Call and Webcast Details
LogicBio will host a conference call and webcast today,
Wednesday, February 2, 2022, at 8:30 a.m. ET to discuss the program
update. To listen to the conference call, please dial +1 (833)
519-1335 (domestic) or +1 (602) 585-9978 (international) using
conference ID number 7545016. A live webcast of the call can be
accessed via the Investors section of the company's website at
https://investor.logicbio.com. A webcast replay will be available
following the call and archived for approximately 30 days.
About LB-001
LB-001 is an investigational, first-in-class,
single-administration, genome editing therapy for early
intervention in methylmalonic acidemia (MMA) using LogicBio's
proprietary GeneRide(TM) drug development platform. GeneRide
technology utilizes a natural DNA repair process called homologous
recombination that enables precise editing of the genome without
the need for exogenous nucleases and promoters that have been
associated with an increased risk of immune response and cancer.
LB-001 is designed to non-disruptively insert a corrective copy of
the methylmalonyl-CoA mutase (MMUT) gene into the albumin locus to
drive lifelong therapeutic levels of MMUT expression in the liver,
the main site of MMUT expression and activity. LB-001 is delivered
to hepatocytes intravenously via liver-targeted, engineered
recombinant adeno-associated virus vector (rAAV-LK03). Preclinical
studies found that LB-001 was safe and demonstrated transduction of
hepatocytes, site-specific genomic integration, and transgene
expression. LB-001-corrected hepatocytes in a mouse model of MMA
demonstrated preferential survival and expansion (selective
advantage), thus contributing to a progressive increase in hepatic
MMUT expression over time. LB-001 resulted in improved growth,
metabolic stability, and survival in MMA mice. The U.S. Food and
Drug Administration (FDA) granted fast track designation, rare
pediatric disease designation and orphan drug designation for
LB-001 for the treatment of MMA. In addition, the European
Medicines Agency (EMA) granted orphan drug designation for LB-001
for the treatment of MMA.
About LogicBio Therapeutics
LogicBio Therapeutics is a clinical-stage genetic medicine
company pioneering genome editing and gene delivery platforms to
address rare and serious diseases from infancy through adulthood.
The company's genome editing platform, GeneRide(TM), is a new
approach to precise gene insertion harnessing a cell's natural DNA
repair process potentially leading to durable therapeutic protein
expression levels. The company's gene delivery platform, sAAVy(TM),
is an adeno-associated virus (AAV) capsid engineering platform
designed to optimize gene delivery for treatments in a broad range
of indications and tissues. The company is based in Lexington, MA.
For more information, visit www.logicbio.com, which does not form a
part of this release.
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ISIN: GB00BD045071
Category Code: PFU
TIDM: ARIX
LEI Code: 213800OVT3AHQCXNIX43
OAM Categories: 3.1. Additional regulated information required to be disclosed under the laws of a Member State
Sequence No.: 140506
EQS News ID: 1275905
End of Announcement EQS News Service
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