Clinical Development of Novel CCK Receptor Antagonists for the Treatment of Inflammatory Pain

Introduction

PNB-001 is the lead molecule that belongs to the 4 chemical series of PNB Vesper Cholecystokinin CCK program. PNB-001 demonstrated, in both in vitro and in vivo preclinical pharmacology models, excellent CCK inhibitory and anti-nociceptive activities to pain resulting from inflammation. All required safety evaluation and PK studies have been completed in GLP certified facilities. The product has excellent stability. DCGI has accorded permission to carry out Phase- I clinical trial.

Stage of Development

Proof of Concept.

Unique Features of the Product/Technology

Successful in synthesizing the molecule with high purity in large scale. The molecule has shown excellent efficacy and safety in studies conducted in variety of animal models. PNB-001 has excellent CCK inhibitory and anti-nociceptive activities to treat variety of pain. Manufacturing process of PNB-001 is not completed but they succeeded in achieving very high purity and could establish stringent QC in the GMP scenario.

Market Potential

Global market potential for pain medication was $50 billion (Global pain relieving drug market analysis 2010-2025, report publication date April 2010). Of this, inflammatory pain market alone is close to $15 billion. Few products are available in market but have huge side effect for example celecoxib.

National/Societal Relevance

Pain is a significant public health problem that costs society at least $560-$635 billion annually.

Pain is currently treated with opiods, which are considered as a major reason for several deaths.

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