Anti-inflammatory compound PN0621 to advance to Phase II
SYDNEY, Australia | October 29, 2007 | Biopharmaceutical company, Peptech Limited (ASX: PTD, AIM: PTDx) today announced the completion of the Phase I trial of its lead compound for rheumatoid arthritis PN0621.
Data from the trial completed in 30 healthy volunteers indicates that ascending single doses of PN0621 administered intravenously and subcutaneously were well tolerated in humans.
The results of the trial, which involved the first administration to humans of a domain antibody derived product, will be key to the successful development of PN0621 and will be used in the design of Phase II trials. The Phase II program will examine the safety and efficacy of PN0621 in the treatment of rheumatoid arthritis and other inflammatory diseases. These trials are expected to commence in the first half of 2008. The Company has already manufactured sufficient quantities of PN0621 to proceed to Phase II trials.
Peptech CEO Dr John Chiplin said: “We are delighted that PN0621 has passed its first clinical milestone and this is a great result both for the company and for those suffering from inflammatory disease. We look forward to moving from healthy volunteers to treating patients as we progress the clinical testing of this new generation treatment.”
PN0621 is based on a domain antibody and has been tailored to be smaller than a conventional antibody while retaining similar properties in terms of capacity to bind to other molecules. This is anticipated to provide advantages over existing antibody therapies in the treatment of inflammatory diseases.
There is a need for new treatments for severe rheumatoid arthritis such as PN0621 because some patients develop resistance to prolonged treatment yet respond when switched to an alternate antibody therapy.
The Phase I trial participants each received a single dose of PN0621 by one of two routes: injection into a vein or under the skin. Starting at a low dose, levels were increased until the predicted therapeutic dose level was exceeded. Clinical data indicates dosing at all levels was well tolerated.
“The clinical safety data, taken together with PN0621’s excellent pre-clinical safety profile and advantages in cost of manufacture, place PN0621 in an excellent position. We can now focus on demonstrating PN0621’s efficacy in treating diseases and look to capitalise on the product’s advantages due to its smaller size compared to full-sized, conventional antibodies," Dr Chiplin concluded.
About PN0621
PN0621 is an anti-TNF, a name given to a class of drugs being developed for the treatment of auto-immune diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. Auto-immune diseases occur when an individual’s immune system mistakenly attacks the body’s own tissues. PN0621 works by blocking the action of TNF (tumour necrosis factor) which is involved in this attack.
Peptech has successfully completed pre-clinical trials of PN0621 where the compound recorded potency levels at least as good as a leading blockbuster anti-TNF drug against rheumatoid arthritis in the same model. The compound also shows good potential for cost competitive commercial production with high levels of production and yield of purified material.
Why do we need another anti-TNF drug?
There are currently three anti-TNF drugs on the market, RemicadeTM, HumiraTM and EnbrelTM. In 2006 these drug had combined global sales of US$10.8 billion, with a projected market value 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 to include, asthma, atherosclerosis and atopic dermatitis and there is also a trend developing in diagnosing and treating the inflammatory conditions at a much earlier stage.
About Peptech
Peptech Limited is a biotechnology company dedicated to developing and providing antibody and peptide-based human therapeutic products for the treatment of cancer and inflammatory diseases. The Company has tapped its unique antibody technologies and revenues generated from its pioneering anti-TNF patents to build a range of therapeutic assets to address large and clinically validated markets. Peptech is transitioning to a mid-stage development company as several products move from pre-clinical stages into human trials, starting with the Company’s lead product, PN0621, a differentiated anti-TNF domain antibody construct.
Clinical Appendix
The following additional information is provided in accordance with the Code of Best Practice for ASX Reporting by Life Science Companies.
Trial Title: A Phase I, single ascending dose, safety and pharmacokinetic study of PN0621 in healthy volunteers.
The Goal of the Trial: The primary endpoint of the unblinded trial was to establish the safety of PN0621 in man. Data was also obtained to understand the distribution of PN0621 in the body to allow for the establishment of safe dosing levels for future trials. Proposed future trials will aim to test both the efficacy and safety of PN0621 in patients with rheumatoid arthritis and other disorders of the immune system.
Investigators
Clinical Investigator: Professor Richard Day, St Vincent’s Hospital
Project Manager: Dr Robert Gay, Peptech Limited
Trial Endpoints
Primary Objective: To establish safety of PN0621 in man.
Secondary Objective: To understand the distribution of PN0621 in the body to allow for the establishment of safe dosing levels for future trials.
Method: Thirty volunteers received a single dose of PN0621 by either intravenous infusion or subcutaneous injection. Starting from a very low dose the health and safety of each volunteer was thoroughly checked before further higher dose levels were administered to other volunteers.
Glossary of Terms
Domain antibody – A therapeutic molecule that has the benefits 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.
Endpoint – The disease, symptom or sign that constitutes one of the target outcomes of a clinical trial
Efficacy – The capacity of a treatment to produce the desired therapeutic effect
Intravenous infusion – A method of introducing fluids into the body by means of a needle injected into a vein.
Pharmacokinetics – The study of the process by which a drug is absorbed, distributed, metabolised, and eliminated by the body.
Single ascending dose – A clinical trial design where each patient only receives one dose of the trial drug. As more patients are entered into the trial the dose level each patient receives is increased.
Subcutaneous injection – A method of introducing fluids into the body by means of a needle injected into the fatty layer of tissue just under the skin.
Unblinded trial – A clinical trial design where every patient receives the active drug and no placebo control is used.
SOURCE: Peptech Limited
