- Treatment with Nypta(R) (Tideglusib) (NP-12) was
tolerated and produced positive effects on Alzheimer's patients in
four of the five efficacy variables examined in the
trial.
- In view of the promising results of this trial, Noscira
is preparing the next Phase IIb trial on Alzheimer's patients in
order to progress with the clinical development of this novel
compound.
MADRID, July 15 /PRNewswire/ -- Noscira, the Grupo Zeltia
(ZEL.MC) subsidiary specialized in researching and developing drugs
for treating neurodegenerative diseases, presented the results of a
Phase IIa clinical trial of Nypta(R) (Tideglusib) on Alzheimer's
disease (AD) at the International Conference on Alzheimer's Disease
(ICAD), held in Honolulu
(Hawaii) from July 10-15, 2010.
Dr. Teodoro del Ser, Director of
Clinical Development at Noscira, gave an oral session in the
"Therapeutic Strategies" symposium in which he reported that
treatment with Nypta(R) (Tideglusib) for 20 weeks was tolerated and
had a positive impact on patients' cognitive performance. In order
for these results to be statistically significant, they must be
confirmed in a Phase IIb trial in which a larger group of patients
will be treated for one year.
The Phase IIa trial, which was conducted at three centers in
Germany based on advice from
experts at the European Medicines Agency (EMA), is the first
clinical trial of Nypta(R) (Tideglusib) on a group of Alzheimer's
patients. The trial was designed with the primary goal of assessing
the safety and tolerability of Nypta(R) (Tideglusib) on these
patients.
The treatment was well tolerated. The drug was also observed to
have a positive effect on patients' cognitive performance, though
this is not statistically significant due to the small sample size
and short treatment period.
Nevertheless, the following findings are indicative of
therapeutic benefit:
- Patients treated with Nypta(R) (Tideglusib) in addition to an
acetylcholinesterase inhibitor as base treatment showed a
consistent improvement in four of the five clinical efficacy
variables that were assessed: Mini Mental State Examination (MMSE),
Alzheimer's Disease Assessment Scale (ADAS-cog), Geriatric
Depression State and Global Clinical Assessment. Those variables
are cognitive-behavioral scales for confirming and quantifying a
person's mental state.
- The improvement was more appreciable in the patients who
attained the highest dose: they improved in the MMSE and ADAS-cog
cognitive scales, the effect being greater than when using
cholinesterase inhibitors alone.
- Moreover, the number of patients that showed stabilization or
improvement in the MMSE scale was significantly greater in the
group treated with Nypta(R) (Tideglusib).
About Zeltia:
Zeltia S.A. is a world-leading biopharmaceutical company
specialized in the development of marine-based drugs for use in
oncology and central nervous system illnesses. Grupo Zeltia
consists mainly of the following companies: PharmaMar, a
biotechnology company that is the world leader in advancing cancer
care through the discovery and development of innovative
marine-derived medicines; Noscira, a biotech firm focused on
discovering and developing new drugs against Alzheimer's disease
and other neurodegenerative diseases of the central nervous system;
Genomica, Spain's leading
molecular diagnostics company; Sylentis, which focuses on
researching therapeutic applications of gene silencing (RNAi); and
a chemical division comprising Zelnova and Xylazel, two highly
profitable companies that are leaders in their respective market
segments.
About Noscira:
Noscira, which is headquartered in Madrid (Spain), is a biopharmaceutical company which
researches and develops innovative drugs for treating and
preventing diseases of the nervous system. Since its inception, the
company has specialized in Alzheimer's disease. Noscira's search
strategy combines a unique, highly-specialized primary screening
platform for marine samples and a strong focus on chemical
optimization.
The company has two clinical compounds (NP-12 and NP-61) which
are well-positioned in the pipeline for treating Alzheimer's
disease. It also has a solid pipeline of products in the
pre-clinical phases. Noscira is a subsidiary of Grupo Zeltia
(Madrid stock exchange: ZEL.MC;
Bloomberg: ZEL SM; Reuters: ZEL.MC), Spain's leading biotechnology and chemical
company.
About Nypta(R) (Tideglusib) (NP-12):
Overexpression of GSK-3 leads to hyperphosphorylation of the tau
protein, an anomaly which occurs in a number of neurodegenerative
diseases known collectively as tauopathies, which include
Alzheimer's disease (AD), progressive supranuclear palsy (PSP) and
Pick disease.
NP-12 is a GSK-3 inhibitor with oral bioavailability and great
therapeutic potential as a disease-modifying treatment for
Alzheimer's disease. NP-12 is currently undergoing Phase II
clinical trials for Alzheimer's disease in the EU.
NP-12, the only GSK-3 inhibitor under clinical development for
AD, has proven to be capable of acting on all of the
histopathological lesions associated with the disease in
experimental models: it reduces phosphorylation of the tau protein
and hippocampal and entorhinal cortex neuron loss, improves spatial
memory deficits and significantly reduces the accumulation of
amyloid plaques in the brain. NP-12 also provides neuroprotection
in vivo and has a potent anti-inflammatory effect in a range of
animal models.
For more information, contact Zeltia at +34 91 444
4500.
This note is also available in the "News" section of the
Zeltia (www.zeltia.com) and Noscira (www.noscira.com)
websites
SOURCE Group Zeltia