Arix Bioscience
plc
Positive clinical
progression in Group Businesses
Further
expansion of Arix pipeline with three new clinical trials
initiated
LONDON, 10 August 2018: Arix Bioscience plc
("Arix") (LSE: ARIX), a global healthcare and life science company
supporting medical innovation, is pleased to note the positive
clinical progression in its following three Group Businesses –
Iterum Therapeutics plc (“Iterum”) (Nasdaq: ITRM), Harpoon
Therapeutics, Inc (“Harpoon”) and Verona Pharma plc (“Verona”)
(AIM: VRP) (Nasdaq: VRNA).
- Iterum Therapeutics, a clinical-stage pharmaceutical company
developing antibiotics against multi-drug resistant pathogens,
initiated a Phase 3 clinical trial of oral sulopenem in
uncomplicated urinary tract Infections, the first of three planned
Phase 3 pivotal trials. Sulopenem is Iterum’s lead compound
and novel oral antibiotic for the treatment of gram-negative,
multi-drug resistant infections. If approved, this could be the
first antibiotic for uncomplicated urinary tract infections in over
20 years and would provide a much-needed treatment option in a
large and growing market. Top-line results are expected in 2H 2019
and NDA submission anticipated by the end of 2019.
- Harpoon Therapeutics, an immuno-oncology company pioneering a
new class of T cell engaging therapeutics, treats first patient
with HPN424 in its Phase 1 clinical study of metastatic
castration-resistant prostate cancer (mCRPC) patients. This is an
important milestone for Harpoon as it transitions to a clinical
stage company.
-
Verona Pharma, a clinical-stage biopharmaceutical company
focused on developing and commercializing innovative therapies for
respiratory diseases, has initiated a Phase 2 clinical trial to
evaluate Nebulized RPL554 as an add on to Dual Bronchodilator
Therapy for COPD Maintenance Treatment. Top line data is expected
in Q1 2019.
Commenting on the news, Joe
Anderson, CEO of Arix Bioscience, said: “We are pleased
to note the initiation of new trials by Iterum Therapeutics,
Harpoon Therapeutics and Verona Pharma. These are important
milestones for the companies that showcase innovative science
across all stages of development, and represent positive
progression in our core portfolio.
“These companies have the potential to create important new
treatments for patients and we look forward to providing further
expertise and capital support to enable them to progress their
products to market.”
Group Business press releases
Please find links to the Iterum
Therapeutics, Harpoon Therapeutics and Verona Pharma announcements
below.
Iterum Initiates
SURE 1, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated
Urinary Tract Infections
DUBLIN and CHICAGO, August 9,
2018 -- Iterum Therapeutics plc (Nasdaq: ITRM), a
clinical-stage pharmaceutical company developing antibiotics
against multi-drug resistant pathogens, today announced its
initiation of the first of three Phase 3 clinical trials. In this
trial, known as Sulopenem for Resistant Enterobacteriaceae (SURE)
1, oral sulopenem etzadroxil combined with probenecid in a bilayer
tablet (oral sulopenem) is compared to oral ciprofloxacin in women
with uncomplicated urinary tract infections (uUTI). Sulopenem is
Iterum’s lead compound and novel antibiotic for the treatment of
gram-negative, multi-drug resistant infections.
Press release available here:
https://www.iterumtx.com/news/press-releases
Harpoon
Therapeutics Treats First Patient with HPN424 in Phase 1 Clinical
Trial of Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Patients
South San Francisco – August 6,
2018 – Harpoon Therapeutics, an immuno-oncology company
pioneering a new class of T cell engaging therapeutics, announced
today that the first patient has been treated with HPN424 in a
Phase 1 clinical study of metastatic castration-resistant prostate
cancer (mCRPC) patients. HPN424 is the first of multiple compounds
in development that are based on the company’s TriTAC (Tri-specific
T cell Activating Construct) platform and designed to penetrate
solid tumors, have extended serum half-life, and recruit patients’
own T cells to destroy malignant tumor cells. The Phase 1 trial is
a multicenter, multinational, open-label, ascending dose study
designed to evaluate the safety, tolerability and pharmacokinetics
of HPN424 in approximately 40 patients with metastatic prostate
cancer.
Press release available here:
https://www.harpoontx.com/news/080618/
Verona Pharma
Initiates Phase 2 Clinical Trial Evaluating Nebulized RPL554 as
Add-on to Dual Bronchodilator Therapy for COPD Maintenance
Treatment
LONDON, Aug. 01, 2018 -- Verona Pharma plc (AIM:VRP)
(Nasdaq:VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical
company focused on developing and commercializing innovative
therapies for respiratory diseases, announces the initiation of a
Phase 2 clinical trial evaluating the effect of nebulized RPL554 as
an add-on to treatment with dual long-acting anti-muscarinic /
long-acting beta2-agonist drugs (“LAMA/LABA”), which are commonly
used in the maintenance treatment of patients with moderate to
severe chronic obstructive pulmonary disease (“COPD”). The first
patients have been enrolled and dosed in the study, and top line
data are expected in the first quarter of 2019.
Press release available here:
http://investors.veronapharma.com/news-releases/news-release-details/verona-pharma-initiates-phase-2-clinical-trial-evaluating
[ENDS]
Enquiries
For more information on Arix, please contact:
Arix Bioscience plc
Charlotte Parry, Head of Investor
Relations
+44 (0)20 7290 1072
charlotte@arixbioscience.com
Optimum Strategic Communications
Mary Clark, Supriya Mathur, Hollie
Vile
+44 203 714 1787
optimum.arix@optimumcomms.com
Burns McClellan (US Media & IR
Enquiries)
Lisa Burns, John Grimaldi, Bill
Slattery Jr., Nancie
Steinberg
+1 212-213-0006
arix@burnsmc.com
About Arix Bioscience plc
Arix Bioscience plc is a global healthcare and life science
company supporting medical innovation. Headquartered in
London and with an office in
New York, Arix Bioscience sources,
finances and builds world class healthcare and life science
businesses addressing medical innovation at all stages of
development. Operations are supported by privileged access to
breakthrough academic science and strategic relationships with
leading research accelerators and global pharmaceutical
companies.
Arix Bioscience plc is listed on the Main Market of the London
Stock Exchange. For further information, please visit
www.arixbioscience.com
About Harpoon Therapeutics, Inc
Harpoon Therapeutics is a clinical-stage immuno-oncology company
founded by Patrick Baeuerle, PhD, a
pioneer in the development of T cell engaging therapies, and MPM
Capital. The company is focused on the discovery and development of
novel T cell engaging biologics for the treatment of cancer.
Harpoon Therapeutics created a novel T cell redirection platform
called TriTAC (Tri-specific T cell Activating Construct) to unleash
the targeted cell-killing properties of a patient's own immune
system through T cell activation. This approach has been optimized
to overcome the limitations of existing immunotherapies to
penetrate tissues and extend serum exposure for superior efficacy
in solid tumors. Harpoon is developing a robust pipeline of TriTAC
candidates. Harpoon has initiated a Phase 1 clinical trial for lead
candidate HPN424, a prostate-specific membrane antigen
(PSMA)-targeting TriTAC, and expects to file an investigational new
drug application for HPN536, a mesothelin-targeting TriTAC soon.
For more information, please visit www.harpoontx.com
About Iterum Therapeutics plc
Iterum Therapeutics plc is a clinical-stage pharmaceutical
company dedicated to developing differentiated antibiotics aimed at
combatting the global crisis of multi-drug resistant pathogens to
significantly improve the lives of people affected by serious and
life-threatening diseases around the world. Iterum Therapeutics is
advancing its first compound, sulopenem, a novel penem antibiotic
compound with oral and IV formulations that has demonstrated potent
in vitro activity against a wide variety of gram-negative,
gram-positive and anaerobic bacteria resistant to other
antibiotics. For more information, please visit
http://www.iterumtx.com
About Verona Pharma plc
Verona Pharma is a clinical-stage biopharmaceutical company
focused on developing and commercializing innovative therapies for
the treatment of respiratory diseases with significant unmet
medical needs. Verona Pharma's product candidate, RPL554, is a
first-in-class, inhaled, dual inhibitor of the enzymes
phosphodiesterase 3 and 4 that acts as both a bronchodilator and an
anti-inflammatory agent in a single compound. In clinical trials,
treatment with RPL554 has been observed to result in statistically
significant improvements in lung function as compared to placebo,
and has shown clinically meaningful and statistically significant
improvements in lung function when administered in addition to
frequently used short- and long-acting bronchodilators as compared
to such bronchodilators administered as a single agent. Verona
Pharma is developing RPL554 for the treatment of chronic
obstructive pulmonary disease (COPD), cystic fibrosis (CF), and
potentially asthma. http://www.veronapharma.com/