Trial for Lead Compound
18 March 2008 - 8:12PM
UK Regulatory
RNS Number:3317Q
Arana Therapeutics Limited
18 March 2008
For Immediate Release 18 March 2008
Arana Therapeutics Limited
Start of Phase II Trial for Lead Compound
- First Phase II clinical trial for Arana
- US Investigational New Drug (IND) application for rheumatoid arthritis
indication planned for Q3/08
17 March 2008 Sydney, Australia: Biotechnology company Arana Therapeutics
Limited (AIM: AAHx; ASX: AAH,) announced that it has commenced recruitment for a
Phase II trial in psoriasis for its lead anti-TNF drug candidate ART621. ART621
is an "anti-TNF" - a class of drugs used for the treatment of inflammatory
diseases such as rheumatoid arthritis, psoriasis and Crohn's disease. ART621
works by blocking the action of TNF (tumour necrosis factor) a protein which is
involved in generation of inflammation.
The study is Arana's inaugural trial following the merger of Peptech and
EvoGenix in August 2007. The study will provide repeat dose, pharmacokinetic,
safety and preliminary anti-TNF efficacy data for ART621 in a psoriasis
population. The results will also be used to inform the design of longer
duration clinical studies in rheumatoid arthritis and other indications.
In November 2007 Arana successfully completed a Phase I clinical trial of ART621
which showed the drug was well tolerated in healthy volunteers. Earlier
pre-clinical trials recorded potency levels at least equivalent to a
market-leading anti-TNF drug in an animal model of rheumatoid arthritis. ART621
was also shown to have design features that make it suitable for commercial
production.
Dr John Chiplin, CEO of Arana said "The commencement of this trial heralds the
start of a very exciting period for Arana as we expand our clinical activities.
This initial study in psoriasis will quickly enable us to obtain the data
necessary to allow our Phase II rheumatoid arthritis program to commence. We
expect to file an IND for ART621 in rheumatoid arthritis with the US Food and
Drug Administration by the end of September 2008. Assuming no delays, we plan to
commence our Phase II rheumatoid arthritis study towards the end of calendar
year 2008, once we have FDA approval for the protocol and positive interim data
from our psoriasis trial."
"Both psoriasis and rheumatoid arthritis are key markets for the currently
registered anti-TNF's. The novel nature of the product should allow ART621, if
successful, to gain a significant share of a very large market," Dr Chiplin
said.
There are currently three major anti-TNF drugs on the market, Remicade(R),
Humira(R) and Enbrel(R). In 2007 these drugs had combined global sales of
US$12.8 billion. With a projected market size of greater than US$20 billion in
2012 this is a rapidly growing market, which is far from saturated.
It is well documented that patients can develop a resistance to one antibody
treatment, but respond to another. The list of indications that can be treated
with anti-TNF drugs is increasing and there is also a trend developing in
diagnosing and treating the inflammatory conditions at a much earlier stage.
Clinical Trial Details
The study known as ART621-201 is designed to evaluate the safety, efficacy and
pharmacokinetics of 3 dose levels of ART621 using a randomised, double-blind,
placebo-controlled design in subjects with plaque psoriasis. The primary
objective is to evaluate the safety and tolerability of subcutaneous injections
of ART621 given every 2 weeks for 6 doses as assessed by adverse events and
clinical laboratory data. Assessments of efficacy will include the Psoriasis
Area and Severity Index (PASI), Physician Global Assessment (PGA), photographs
and the Dermatology Life Quality Index (DLQI).
Each subject will be on-study for 18-20 weeks, consisting of a 2-4 week
screening period, followed by a 12 week treatment period and then a 4 week
follow up. Each subject will receive their designated dose of ART621 on 6
occasions over the 12 week treatment period and will be monitored closely
throughout.
The study will be conducted to ICH GCP standard at two Australian study centres
- Nucleus Network in Melbourne and CMAX in Adelaide - both of which have
experience in psoriasis trials and biological therapies. The study expects to
recruit between 40-60 subjects over a 4-6 month period. The first patient is
expected to be dosed during the next several weeks with the formal results of
the study anticipated approximately 4 months after recruitment closes.
More details are included in the attached Appendix.
About Arana Therapeutics:
Arana Therapeutics (AIM: AAHx ; ASX: AAH) is an international biopharmaceutical
company formed through the merger of Peptech and EvoGenix in August 2007. The
company uses superior technology to develop next generation drugs that will
improve the lives of patients with inflammatory diseases and cancer.
Arana Therapeutics' innovative engineering technologies provide the basis for
clinical development in the antibody space, a market which draws on high demand.
Arana Therapeutics has the financial stability and management expertise to
accelerate its clinical programs, and is on track to have at least 3 clinical
stage assets within three years.
Arana is listed on the Australian Securities Exchange (ASX) and the London Stock
Exchange (AIM).
The pipeline consists of four lead drug programs: ART621 to treat severe
rheumatoid arthritis, psoriasis and other inflammatory diseases; ART010 to treat
osteoporosis and bone cancer; ART104 to treat solid tumours in colorectal
cancer; and ART150 for lung cancer and melanoma. Additionally, the company has
earlier stage products in development for the treatment of a range of conditions
including age related macular degeneration, psoriasis, colorectal cancer, and
leukemia.
Arana has recurring revenues from commercial and development partnerships with
six international companies including GSK, CSL, Centocor (J&J) and Abbott
Laboratories.
For further information: www.arana.com
For further information, please contact:
Arana Therapeutics Limited
Dr John Chiplin, Chief Executive Officer +61 (0)2 8061 9900
Niall Henderson, Chief Financial Officer +61 (0)2 8061 9900
Buchanan Communication
Lisa Baderoon/Rebecca Skye Dietrich +44 (0)20 7466 5000
Nomura Code Securities
Charles Walker +44 (0)20 7776 1206
Clinical Appendix
The following additional information is provided in accordance with the Code of
Best Practice for ASX Reporting by Life Science Companies.
+----------------+-------------------------------------------------------------+
|Protocol No. |ART621-201 |
+----------------+-------------------------------------------------------------+
|Trial title: |A randomised, double-blind, placebo-controlled, study to |
| |evaluate the safety, efficacy and pharmacokinetics of three |
| |doses of ART621 following multiple dose administration in |
| |subjects with stable plaque psoriasis |
+----------------+-------------------------------------------------------------+
|Type of trial: |Phase II dose ranging |
+----------------+-------------------------------------------------------------+
|Sponsor: |Arana Therapeutics Limited |
+----------------+-------------------------------------------------------------+
|Investigational |ART621 |
|Product: | |
+----------------+-------------------------------------------------------------+
|Trial design: |Randomised, double-blind, placebo-controlled, dose ranging |
| |study |
+----------------+-------------------------------------------------------------+
|Trial duration |18-20 weeks: 2-4 weeks screening, 12 week treatment period (6|
| |doses ART621) and 4 week follow-up period |
+----------------+-------------------------------------------------------------+
|Doses to be |Placebo (0mg/kg) or ART621: 0.5 mg/kg, 1 mg/kg or 2 mg/kg |
|studied: | |
| |(1:1:1:1 ratio) |
+----------------+-------------------------------------------------------------+
|Dosage forms: |49 mg/mL solution for parenteral administration (2 mL per |
| |vial) |
+----------------+-------------------------------------------------------------+
|Route: |Subcutaneous injection to lower abdomen |
+----------------+-------------------------------------------------------------+
|Trial centres: |Nucleus Network, Melbourne and CMAX, Adelaide |
+----------------+-------------------------------------------------------------+
|Primary |Evaluate the safety and tolerability of subcutaneous |
|objective: |injections of ART621 given every 2 weeks in subjects with |
| |stable plaque psoriasis |
+----------------+-------------------------------------------------------------+
|Secondary |- Change in Psoriasis Area Severity Index (PASI) and |
|objective: |Physician Global Assessment (PGA) scores between baseline and|
| |Week 12 |
| | |
| |- Change in Dermatology Life Quality Index (DLQI) between |
| |baseline and week 12) |
| | |
| |- Assess ART621 pharmacokinetic parameters following multiple|
| |dosing |
+----------------+-------------------------------------------------------------+
|Quality |Conducted to ICH Good Clinical Practice |
+----------------+-------------------------------------------------------------+
|Recruitment |40 to 60 subjects will be randomised (10 - 15 subjects per |
| |treatment group). Recruitment is expected to take 4-6 months |
+----------------+-------------------------------------------------------------+
|Trial |Subjects with clinically stable plaque psoriasis |
|population: | |
+----------------+-------------------------------------------------------------+
|Dosing regimen: |Subcutaneous injections of ART621 every 2 weeks for 12 weeks |
| |(6 doses) |
+----------------+-------------------------------------------------------------+
|Safety |Adverse event (AE) reports and clinical laboratory parameters|
|parameters: |(haematology, liver function, electrolytes, renal function) |
| |and electrocardiogram (ECG) recording |
+----------------+-------------------------------------------------------------+
|Efficacy |Psoriasis Area Severity Index (PASI) Score, Physician's |
|parameters: |Global Assessment (PGA) and Dermatology Life Quality Index |
| |(DLQI) |
+----------------+-------------------------------------------------------------+
|Statistical |Descriptive statistics will be used to assess selected |
|analysis: |demographic, safety, pharmacokinetic and efficacy endpoints. |
+----------------+-------------------------------------------------------------+
Glossary of Terms:
ART621 - A human domain-based antibody consisting of a domain antibody directed
against TNF combined with an antibody Fc region. The Fc region is the part of an
antibody that provides immune effector function and other characteristics such
as half-life.
Domain antibody - Molecules which exhibit the binding properties to a biological
target characteristic of a full-sized antibody, but are considerably smaller in
size. As such domain antibodies are expected to possess characteristics of both
small molecules and conventional antibodies. Like small molecules, domain
antibodies are small in size and highly stable, resulting in a choice of
therapeutic formats, delivery formulations and manufacture options. And, like
conventional antibodies, domain antibodies can be designed to have specificity
and high affinity for the biological target of interest.
Domain-based antibody - A therapeutic molecule which incorporates a domain
antibody within a larger antibody-derived framework.
Double blind trial - A clinical trial in which the method for analysing data has
been specified in the protocol before the study has begun (prospective), the
patients have been randomly assigned to receive either the study drug or
alternative treatment, and in which neither the patient nor the physician
conducting the study know which treatment is being given to the patient.
Endpoint - The specified disease, symptom, sign or assessment(s) that
constitutes one of the target outcomes of a clinical trial.
ICH GCP - An internationally agreed standard for the conduct of clinical trials
using medicinal products to ensure a) the protection of subjects participating
in the trial b) clarity on responsibilities for all parties involved in
conducting the trial and c) the integrity of the data generated by the trial is
maintained.
Pharmacokinetics - The study of the process by which a drug is absorbed,
distributed, metabolised, and eliminated by the body.
Psoriasis: an inflammatory disease of the skin associated with increased levels
of TNF. Anti-TNF therapy has shown major benefit in the treatment of this
disease.
Randomised Trial - A trial to see if a drug may be effective and safe at
treating a condition. Groups of patients are divided and randomly (by chance)
allocated to either receive the drug being tested or its matching inactive form
(placebo).
Subcutaneous injection - A method of introducing medicinal products into the
body by means of a needle injected into the layer of tissue just under the skin.
Tumour necrosis factor (TNF) - A protein which is up regulated in many
inflammatory diseases. Inhibition of TNF has been shown to have therapeutic
advantages in the treatment of several major human inflammatory diseases such as
rheumatoid arthritis and psoriasis.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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