Noscira presents results of Nypta Phase IIa clinical trial for AD at ICAD 2010

Jul 16 2010

- 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.

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).