WOBURN, Mass. and RAMAT GAN, Israel, Feb. 11 /PRNewswire/ -- Predix Pharmaceuticals Inc., a drug discovery and development company, announced today the initiation of Phase I clinical trials of PRX-00023, the first drug candidate discovered based on computer generated GPCR models and optimized with integrated computational-medicinal chemistry. The compound is a proprietary dual action serotonin 1A (5HT1A) receptor agonist / sigma-1 antagonist intended to treat anxiety, attention deficit hyperactivity (ADHD) and other neuropsychiatric disorders.
"Moving a drug from in-silico discovery, through optimization and into clinical trials in less than two years is a remarkable achievement for the company and validates the power of our platform," said Oren Becker, PhD., co- founder and Chief Scientific Officer at Predix.
The primary objectives of this single dose-escalation study are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound. The first study will include over 40 healthy volunteers and results are expected by the first half of the year. A multiple dose study in healthy volunteers could begin in the next quarter.
"The initiation of this Phase I clinical trial for PRX-00023 represents an important milestone for Predix. We believe PRX-00023 has great potential to become a novel anti-anxiety agent as well as help treat other conditions such as ADHD and depression," said Silvia Noiman, PhD, MBA, co-founder of Predix and Senior VP of Pipeline Management. "Our strategy is to conduct two Phase I trials and then look to out-license this series of compounds for development with a large pharmaceutical partner."
About Predix
Predix Pharmaceuticals Inc. develops proprietary computer-based methods to improve the efficiency of drug discovery and optimization and utilizes these methods exclusively for its in house drug discovery and development. Leveraging its proprietary technology, Predix has created a diverse clinical and pre-clinical stage drug development pipeline focused in the GPCR and ion channel areas. The Company's current pipeline includes one program in Phase I clinical trials, two programs in preclinical stage and four additional programs in lead discovery and early optimization. Predix expects to retain a minority of its clinical programs in house through Phase 2 and Phase 3 clinical trials, while generating early upfront and milestone revenues, as well as royalties from out-licensing most of its novel compounds following Phase I safety studies. Based on its novel technology platform under Drs. Becker and Noiman integrated with medicinal chemistry under Senior VP of Drug Discovery, Dr. Dale Dhanoa, Predix has the capacity to move 1-2 new chemical entities into the clinic each year.
In addition to the 5-HT1A program, Predix is using its proprietary in silico GPCR models and computational platform for optimizing antagonists of serotonin 5-HT2B for pulmonary hypertension and pulmonary fibrosis and serotonin 5-HT4 agonists for Alzheimer's Disease and irritable bowel syndrome. The company is also conducting early work on peptide-based GPCRs and ion channel drug candidates.
Predix was incorporated in December, 2000, with its headquarters, medicinal chemistry, and drug development in Woburn, Massachusetts, and its computational division in Ramat Gan, Israel.
For More Information:
Christine Hayden
(781) 376-0821 Ext. 1010
http://www.predixpharm.com/
Predix Pharmaceuticals Inc.