Noscira Initiates Phase II Clinical Trials With NP 12, Its First Drug For Alzheimer's Disease

Main Category: Alzheimer's / Dementia
Also Included In: Clinical Trials / Drug Trials
Article Date: 28 Oct 2008 - 1:00 PDT

email to a friend   printer friendly   opinions  

Noscira, a company of Zeltia group devoted to the research and development of innovative drugs for the treatment of diseases of the nervous system, has received the approval of the Austrian health authorities and the Ethics Committee for the initiation of the first Phase II study with NP-12 for the treatment of Alzheimer's disease.

NP-12, the first compound of Noscira's product pipeline, is an innovative drug of a new family of compounds. NP12 acts on the two main cellular processes that cause Alzheimer's disease, tau hyperphosphorylation and β-amyloid aggregation. Both in Alzheimer's disease and other neurodegenerative diseases, NP-12 may have a modifier and clinically relevant effect.

In Phase II clinical trials, NP12 will be administered to patients with Alzheimer's disease. Noscira is the only company in the world to have reached the clinical development stage with a compound for Alzheimer's disease, designed to inhibit the GSK3 enzyme.

"This milestone reached by Noscira shows our progress in the search for new treatments, not only against cancer, through PharmaMar research activities, but also against other socially relevant diseases such as Alzheimer's disease" said Jose Maria Fernandez Sousa-Faro, President of Zeltia Group.

In words of Teodoro del Ser, Director of Clinical Development at Noscira, "We are pleased with the outcome of our work and with the efforts made at Noscira and we are confident that Phase II clinical trials results of NP12 will support our clinical expectations"

In May 2006, it was initiated NP-12 clinical development for the treatment of Alzheimer's disease, in order to test NP12's safety and pharmacokinetics. More than 160 healthy subjects of young and old age have been treated with oral NP- 12 in three Phase I studies, the compound being generally well tolerated.

In animal models of Alzheimer's disease, it was demonstrated that NP12 improves cognitive performance and reduces amyloid deposits, hyperphosphorylation and tau aggregation, neuroinflammation and, most importantly, neuron loss, the ultimate cause of the clinical profile of progressive and widespread deterioration.

Consistency of these findings supports the expectation that the compound may have a modifying effect of Alzheimer's disease when administered to patients.

Alzheimer's disease

Alzheimer's disease ('AD') is a neurodegenerative disease characterised clinically by the progressive disorders of cognitive functions, especially memory in initial phases, and autonomy and behaviour. Typical histopathological damages of AD are β- amyloid peptide deposits in the brain cortex and in the subcortical gray matter (extracellular neuritic senile plaques) and tau protein deposits (intraneuronal neurofibrillary tangles), but the main cause of the dementia profile is the progressive and diffuse loss of synapse and neurons.

Around 26 million people are affected by Alzheimer's disease worldwide, of which more than the half is entitled to seven major pharmaceutical markets (USA, Japan, Germany, UK, France, Italy and Spain). It is calculated that the number of AD sufferers worldwide will triple by the year 2050. The increase of the prevalence is a result of the progressive rise in life expectancy, the improvement in health care and diagnosis techniques.

Current treatment for Alzheimer's disease is merely symptomatic, showing slight improvements and effectiveness during a limited period of time. There is an urgent need for the developing a treatment with clinical efficacy, capable of delaying or modifying the neurodegenerative progress associated with AD.

About Noscira

Noscira is a biopharmaceutical company devoted to the research and development of innovative drugs for the treatment and prevention of diseases of the nervous system. Since Noscira was created in 2000, the company has focused its activity on Alzheimer's disease, and more specifically on the search for new approaches capable of modifying the progress of the disease and produce a cognitive and functional improvement in patients.

Our strategy combines a unique, highly specialised primary screening platform of marine samples with a strong chemical optimisation effort to transform the identified compounds with biological activity into candidates for toxicological and clinical development. For this purpose, Noscira has access to Pharmamar's collection of more than 65,000 marine samples.

http://www.noscira.com

Noscira has two compounds in clinical development with different mechanisms of action:

- NP-12, a GSK-3 inhibitor, currently starting phase II clinical trials (4Q08)

- a modulator of the amyloid pathogenic cascade, in phase I clinical trials Noscira currently have several NCEs (New Chemical Entities) relating to three new mechanisms of action in proof of concept. In addition, the first phases of characterisation have been opened for other conditions within the neurodegenerative disease field.

Noscira is a subsidiary of Zeltia (Madrid Stock Exchage: ZEL.MC; Bloomberg: ZEL SM; Reuters: ZEL.MC), Spanish group leader in biotechnology and chemical sector. For Additional information about Noscira contact the website http://www.noscira.com

About NP-12

NP-12 is a molecule originating from a rational design program with inhibitory activity of GSK-3. The effects of chronic administration of NP-12 have been identified in three models of transgenic mice that replicate typical pathological features of AD: a doubletransgenic conditional Tet/GSK-3 that overexpresses GSK-3 and produces hyperphosphorilated tau protein deposits in the brain, a double transgenic of APPV717I x PS1A246E producing β-amyloid and brain senile plaques, and a double-transgenic of APPK670N-M671L x TauVLW that produces fibrillary deposits of hyperphosphorilated tau, amyloid plaques, gliosis and neuron loss.

The chronic oral treatment with NP-12 reduces a) reactive inflammatory gliosis and tau phosphorylation in Tet/GSK-3β transgenic mouse, b) brain amyloid burden and plaque volume in APPV717IxPS1A246E transgenic mouse, and c) amyloid deposit, tau phosphorylation, reactive gliosis and cell death in APPK670N-M671LxTauVLW transgenic mouse. Cognitive improvement was also observed in APPV717IxPS1A246E and APPK670NM671LxTauVLW mice.

NP-12 improves all major neurodegenerative parameters of AD in animal models, particularly neuron loss, which is the ultimate cause of the clinical profile of progressive and widespread deterioration.

In May 2006 clinical development of NP-12 for the treatment of Alzheimer's disease was initiated. More than 160 healthy subjects of young and old age have been orally treated with NP-12 in three Phase I studies, the compound being generally well tolerated. In Phase II clinical trials being currently initiated (3Q2008), NP12 will be administered to patients with Alzheimer's disease and other Tauopathies. Similarly, a Phase II clinical trial of NP12 for the treatment of the Progressive

Supranuclear Palsy (PSP) is planned to be initiated in the first half of 2009.

Other research projects at Noscira:

- Amyloidosis inhibitors

In April 2007 clinical development of NP-61 for the treatment of Alzheimer's disease was commenced, with the aim of testing the safety and pharmacokinetics of the compound.

β-amyloid is a peptide generated in pathological conditions that may aggregate forming insoluble extracellular plaques, which is the first step in the pathogenic cascade that causes neuronal death and dementia. There have been different therapeutic approaches based on this hypothesis that search to regulate the production and/or aggregation of β-amyloid, such as the modulation in acetyl cholinesterase (AChE) or the selective inhibition of β-secretases (BACE).

Noscira is developing NP-61 as a modulator of the β-amyloid aggregation for the treatment of patients with AD, with the potential to provide a modifier effect in the course of the disease, with a symptomatic effect of cognitive improvement in the patients.

- Neuroprotection
- Trophic factors
- Neuro-regeneration. Study of the regenerative capacity of the glial envelope

Source
Belén Sopesén
Managing Director
and
Alfonso Hurtado de Mendoza
Chief Financial Officer
http://www.noscira.com

• Additional
• References
• Citations

Article adapted by Medical News Today from original press release.
Visit our alzheimer's / dementia section for the latest news on this subject.

There are no references listed for this article.

Please use one of the following formats to cite this article in your essay, paper or report:

MLA

Noscira. "Noscira Initiates Phase II Clinical Trials With NP 12, Its First Drug For Alzheimer's Disease." Medical News Today. MediLexicon, Intl., 28 Oct. 2008. Web.
16 Feb. 2012. <http://www.medicalnewstoday.com/releases/126995.php>

---

APA

Noscira. (2008, October 28). "Noscira Initiates Phase II Clinical Trials With NP 12, Its First Drug For Alzheimer's Disease." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/126995.php.

---

Please note: If no author information is provided, the source is cited instead.