CogState Ltd
Overview
CogState Ltd is a public biotechnology company established in 1999 with headquarters in Melbourne and listed on the Australian Stock Exchange (ASX:CGS).
CogState develops and commercializes products for the diagnosis and treatment of neurodegenerative disorders. The company currently sells six computerized cognitive test diagnostic products in the US, Europe and Australia, five of which were developed internally and one of which was licensed from Pfizer Pharmaceuticals.
The company also has ongoing therapeutic development projects for the treatment of Alzheimer’s Disease and Parkinson’s Disease, both of which involve small molecule drugs licensed to CogState.
Competitive advantages
The therapeutic division of the company finds, evaluates, negotiates and in-licenses Central Nervous System (CNS) compounds in the early preclinical stage of drug development and project manages (via outsourcing) the development of these compounds.
When significant value has been added, the company subsequently on-license these compounds to commercialisation partners. The therapeutic division of the company has two drug development projects under way; one for the treatment of Alzheimer's disease (Cog0192; licensed from Taisho Pharmaceuticals in Japan and from Pacific Northwest Biotechnology in US) and one for the treatment of Parkinson's Disease (Cog0193; licensed from Brain Research Ltd in Israel).
Cog0192 is a program focused upon finding small molecules which stimulate angiotensin 4 (AT4) receptors in the brain, which have been implicated in animal models as potentially having a role in Alzheimer’s Disease.
The company recently announced that it had developed the world’s first bioassay for AT4, which is an in-vitro test that can be used to greatly accelerate the search for a lead compound. Using the bioassay, the company also announced having found a lead tripeptide structure which is being used to model a drug for human clinical trials in the ensuing months.
Cog0193 (NLT) is a program focused on the development of a carrier molecule for tyrosine, a precursor of dopamine which is a drug which is deficient in the brains of people with Parkinson’s Disease. The company recently announced that it had synthesized this molecule and was using it in a series of preparatory animal trials before initiating human clinical trials, with an objective to be in human trials within 18 months.
The diagnostic division of the company sells six branded 15-minute computerized cognitive tests which provide a quantitative, validated, rapid and accurate measurement of cognitive function: CogMaze (a human analog of the Morris Water Maze Test, Maruff Schizophrenia Index, CogState Clinical, CogSport, CogHealth, and CogSafe.
For subtle brain disease, procedures, or injury CogState Ltd diagnostic tools are more reliable, sensitive and time and cost effective than conventional approaches because the technology detects brain dysfunction by comparing the cognitive performance of individuals to themselves, not only to the normal distribution.
CogState’s diagnostics can be used rapidly, distributed widely and are not effected by social, language or educational background. Their application in the target markets can result in high quality and cost effective care of individuals. These tests have been extensively used by several major companies (US pharmaceutical companies as outlined on our website press releases) and agencies such as the Centre for Disease Control (CDC, Atlanta) are using these tests either in all Phase I trials, or as an endpoint in Phase III trials (schizophrenia, ADHD, depression, bipolar disorder, MCI) or as an endpoint in epidemiological trials (HIV dementia, post operative cognitive disorders, post CABG).
Main business focus/
Listing by sector:
- Medical Devices - Neurology Devices
- Clinical Trials
- Diagnostics
Competitive Advantages
The therapeutic division of the company finds, evaluates, negotiates and in-licenses Central Nervous System (CNS) compounds in the early preclinical stage of drug development and project manages (via outsourcing) the development of these compounds.
When significant value has been added, the company subsequently on-license these compounds to commercialisation partners. The therapeutic division of the company has two drug development projects under way; one for the treatment of Alzheimer's disease (Cog0192; licensed from Taisho Pharmaceuticals in Japan and from Pacific Northwest Biotechnology in US) and one for the treatment of Parkinson's Disease (Cog0193; licensed from Brain Research Ltd in Israel).
Cog0192 is a program focused upon finding small molecules which stimulate angiotensin 4 (AT4) receptors in the brain, which have been implicated in animal models as potentially having a role in Alzheimer’s Disease.
The company recently announced that it had developed the world’s first bioassay for AT4, which is an in-vitro test that can be used to greatly accelerate the search for a lead compound. Using the bioassay, the company also announced having found a lead tripeptide structure which is being used to model a drug for human clinical trials in the ensuing months.
Cog0193 (NLT) is a program focused on the development of a carrier molecule for tyrosine, a precursor of dopamine which is a drug which is deficient in the brains of people with Parkinson’s Disease. The company recently announced that it had synthesized this molecule and was using it in a series of preparatory animal trials before initiating human clinical trials, with an objective to be in human trials within 18 months.
The diagnostic division of the company sells six branded 15-minute computerized cognitive tests which provide a quantitative, validated, rapid and accurate measurement of cognitive function: CogMaze (a human analog of the Morris Water Maze Test, Maruff Schizophrenia Index, CogState Clinical, CogSport, CogHealth, and CogSafe.
For subtle brain disease, procedures, or injury CogState Ltd diagnostic tools are more reliable, sensitive and time and cost effective than conventional approaches because the technology detects brain dysfunction by comparing the cognitive performance of individuals to themselves, not only to the normal distribution.
CogState’s diagnostics can be used rapidly, distributed widely and are not effected by social, language or educational background. Their application in the target markets can result in high quality and cost effective care of individuals. These tests have been extensively used by several major companies (US pharmaceutical companies as outlined on our website press releases) and agencies such as the Centre for Disease Control (CDC, Atlanta) are using these tests either in all Phase I trials, or as an endpoint in Phase III trials (schizophrenia, ADHD, depression, bipolar disorder, MCI) or as an endpoint in epidemiological trials (HIV dementia, post operative cognitive disorders, post CABG).
Technology/IP
The six marketed cognitive test products are:
- CogState Clinical— sold to biopharmaceutical companies for use in human clinical trials to detect changes in cognition secondary to drug effects. Specific applications are in Phase I clinical trials to find out at the earliest possible time whether a new drug has harmful or positive effects on brain function, in Phase II-III trials to demonstrate and quantify a cognitive effect in order to support labeling claims, and in Phase IV trials to support marketing. This test uses a computerized display of playing cards to evaluate 300 responses in a 12-15 period and measures attention, memory and executive function. Results are automatically compared statistically to previous results on the test and statistics compute changes in scores of an individual to not only the normal distribution, but also to their own previous scores.
- CogMaze—a human analog of the Morris Water Maze test for spatial memory, a pattern maze executive function test for strategic learning. This test is particularly suitable for measuring the effect of drugs on treating the symptoms of ADHD, schizophrenia and certain disorders of cognition associated with neurodegenerative diseases.
- Maruff Schizophrenia Index, a verbal learning test specifically designed for use in multi-center schizophrenia trials in different countries—where a cross cultural test is required for a pooled analysis. The test can be used in for language.
- CogSport—sold to sporting organizations and through distributors of sporting equipment for the assessment of baseline and the tracking of concussion resolution following head injuries in individuals involved in contact sports.
- CogHealth and Concussion Sentinel— sold to sporting organizations and through distributors of sporting equipment for the assessment of baseline and the tracking of concussion resolution following head injuries in individuals involved in contact sports. In the US this product has the brand name of Concussion Sentinel.
CogHealth—sold to medical practitioners and individuals for the detection of early Alzheimer’s Disease as an annual screening test.
- CogSafe— sold to occupational health organizations for the measurement of cognitive change in workers at risk.
These tests are distributed and analysed via the internet, are independent of language and culture, can be repeated often, do not require a skilled administrator, and provide an accurate measurement of change by comparing an individual's performance to themselves.
Users now number over 50 and include major corporations such as Pfizer, Johnson & Johnson, and elite sporting bodies such as the Australian Football League, South African Rugby Football Union and the Jockey Club of Great Britain. The company has recently signed an agreement with Schutt Sports, the world’s largest manufacturer of helmets for American Football players. Schutt is sponsoring a distribution of free CogSport tests under the brand 'Concussion Sentinel' to up to 1 million football players in 20,000 high schools and 1,200 colleges in the US during 2004-5.
The company also announced that it had been audited by a major US pharmaceutical company and was on the way to reach full compliance, by which time it will be able to pursue a series of major trials with revenues for these trials ranging from US$20-100k each, recognised over the 2-18 month course of these trials.
The two drug technologies being developed are:
Project 1 Preclinical
Cog0192 is directed at developing a small molecule, which will be orally absorbed and cross the blood brain barrier for the treatment of Alzheimer’s Disease. The program is focused on modifying Angiotensin 4 (AT4) receptors which are found predominantly in areas of the brain believed to be crucial for memory formation and are also implicated in Alzheimer’s Disease (the hippocampus). The series of compounds in this project are still in the preclinical stage of development. The company has developed a bioassay for measuring the efficacy of AT4 agonists in cognition enhancement with picomolar sensitivity. The company has also identified a low molecular weight compound with nanomolar affinity and activity in the bioassay (also confirmed in a Morris Water Maze trial) and is in the process of seeking to model a small molecule analog of this structure to bring forward into toxicological studies.
Project 2 Preclinical
Cog0193 is directed at developing a small molecule, which will be orally absorbed and cross the blood brain barrier for the treatment of Parkinson’s Disease. The aim of the program is to increase dopamine available to brain cells by increasing levels of the metabolic precursor to dopamine, tyrosine. Generally tyrosine cannot efficiently cross from the blood into the brain. Experimental results suggest that Cog0392, a tyrosine-fatty acid molecule combination (n-linoleic acid tyrosine) is absorbed orally and distributed easily to the brain. A small human clinical trial of Cog0392 conducted in Israel produced no side effects with a low dose of drug being administered in healthy adults, but the program is still in the preclinical stage of development. The company has manufactured several grams of this compound and is in the process of replicating as series of pharmacology trials in animal models of Parkinson's Disease before beginning toxicological studies in two species. This product was licensed from Brain Research Ltd in Israel and was developed by Professor Shlomo Yehuda from Bar Ilan University in Israel.
Commercialization Strategy & Financing Plans
Please see the company profile. The company is a public company listed on the Australian Stock Exchange (CGS).
| Product Name | Therapeutic Area | Phase | Country(s) Available |
| Cog0192 AT4 | Alzheimer's Disease, Mild Cognitive Impairment, Cognitive Stimulant | Preclinical Testing | Worldwide |
| Cog-0193 NLT | Parkinson's Disease, ADHD | Preclinical Testing | Worldwide |
| CogState Cognitive Tests for clinical trials | schizophrenia, MCI, Alzheimer's Disease, ADHD, HIV, HIV dementia, depression, bipolar disorder, CABG | Currently Marketed | Worldwide |
Key Executives
- Martyn Myer, BE MESc MSM—Coles Myer (CHAIRMAN)
- Dr. Peter Bick MD MBBS MBA ABPN, CEO & Director
- Influence Inc, Skagus Group, VC, Quintiles
- Prof. Paul Maruff, PhD MPsych, CSO
- MHRI, La Trobe University
- Dr. David Darby MBBS FRACP PhD, CMO & Director
- MHRI, Harvard, U. Melbourne
- Dr Adam Whybrew,PhD BSc(Physics), Bus Dev Mgr
- Cambridge/Oxford University, Oxford Lasers, UK
- Brad O’Connor, CPA, CFO and Secretary
- PricewaterhouseCoopers, Nextec, Spherion Group
- Dr. Geoff Brooke, MBBS MBA—GBS Ventures (Director)
- Richard Morgan, Cbiol, MIBiol, Dip RCPath—Glaxo Smith Kline (Director)
- Hon Dr. Michael Wooldridge, MBBS MBA—Ex-Minister of Health (Director)
Contact Details
| Contact person | Mr Brad O'Connor |
|---|---|
| Job Title | CEO |
| Address | Level 7, 21 Victoria Street |
| City/Suburb | Melbourne |
| State | Victoria |
| boconnor@cogstate.com | |
| Phone | +61 3 9664 1300 |
| Fax | +61 3 9664 1301 |
| Website | http://www.cogstate.com |
