Hyderabad-based drug developer Suven Life Sciences said on Thursday that it has completed the phase 1 multiple ascending dose study of SUVN-502 molecule for Alzheimer's disease in healthy volunteers. Suven would present the results from the phase -1 program at the International Conference on Alzheimer's disease (ICAD) at Vienna, Austria during July-2009.
Explaining the results of the phase I trials, the company said the tolerability of SUVN-502 up to the highest dose administered has been excellent. No serious adverse events occurred and no clinically significant changes or study medication related abnormalities were observed with respect to ECGs and laboratory evaluations, the company said in a release to the stock exchanges.
Patent has been granted to SUVN-502 in several countries around the globe with validity until 2023. Suven is in discussions with 8 potential licensing partners for this compound. Timing of the licensing would depend on the deal terms and the ability to move the molecule to the next level of clinical studies.
In a parallel development, for raising around $20 million required for the phase II trials of the molecule, the company is learnt to be in the process of raising funds through a combination of debt, equity and a strategic partner. The strategic partner could be either a private equity player or a pharmaceutical company.
While phase II trials are expected to commence by the end of this year in the U.S. and Europe, the company anticipates that SUVN-502 can be launched in the major regulated markets by 2013. The U.S. and Europe have the largest number of people suffering from Alzheimer's disease.
According to the Alzheimer's Association, a leading voluntary health organization in Alzheimer care, support and research, an estimated 5.3 million Americans have Alzheimer's and the direct and indirect costs of Alzheimer's and other dementias to Medicare, Medicaid and businesses amount to more than $148 billion each year.
Speaking on this development, Venkat Jasti, CEO, Suven Life Sciences said, We are extremely glad with the outcome of the phase-1 trials of SUVN-502. This is a significant development for our organization as this molecule is our first invention and has a potential to be first-in-class and best- in -class for the treatment of Alzheimer's disease and other disorders of memory.
On the Bombay Stock Exchange, Suven Life Sciences was last trading at Rs.16.92, up 20% over the previous close with a volume of 4.36 lakh shares compared to a 2-week average daily volume of 55,852 shares.
For comments and feedback: contact firstname.lastname@example.org