PNB VESPER Signs Agreements with NIH-NIDA, USA to Develop Drugs for Addiction Disorders

Business Wire India
In a significant development, PNB VESPER, a research-based biopharmaceutical company headquartered in Kochi, Kerala has signed agreements with the National Institute on Drug Abuse (NIDA), under NIH USA, the lead federal agency supporting scientific research on drug abuse and addiction disorders, to develop drugs for opioid and cocaine addiction disorders. As per the agreements, NIDA will evaluate Three of the molecules developed by PNB VESPER, PNB 091, PNB 081 and PNB 101 as potential drugs for the treatment of opioid and cocaine addiction-related disorders. 
 
PNB VESPER, which has completed the preclinical studies of the molecules, will soon file the Investigational New Drug applications with the US Food and Drug Administration. The company is planning to start clinical trials of the molecules in the USA as soon as it completes the ongoing studies with NIDA and IND studies, which will be over before end of 2024.

While commenting on the collaboration, P. N. Balaram, Director and CEO, of PNB VESPER, said, “We are very happy and proud to associate with NIDA for developing drugs for opioid and cocaine addiction disorders, which is a major issue in the USA. Our molecules were selected by the US Agency for testing and development after a series of due diligence processes by the senior scientists under NIH and the US government.”

Drug overdose and abuse is a major public health crisis in the USA as well as globally. In the US, Millions of people are suffering from it and Thousands are killed by the same every day. As per a recent report by the Centers for Disease Control and Prevention (CDC), 206,699 people died due to drug overdose, mostly opioid addiction, in 2022. The number of deaths caused by overdose is higher than the toll from gun and car crash deaths combined. The national spending on addiction-related disorders is close to US $700 billion annually. Opioid addiction is a chronic disease that causes major health, social and economic problems. In the past 15 years, various initiatives were launched by the US government and spent billions of dollars to develop safe drugs for the disorders.

Dr. Eric Lattmann, Vice President, PNB VESPER, said, “Our molecules have great potential to treat opioid and cocaine addiction disorders. PNB 091 is being evaluated for opioid addiction disorders and PNB081 for cocaine addiction disorders. We are looking forward to initiating the clinical trials after completing
the studies with NIDA.”

The origin of the opioid crisis in the US dates back to the late 1990s when opioids were increasingly prescribed for pain management, resulting in a rise in overall opioid use in the subsequent years. The commonly used opioids include opiates, oxycodone, hydrocodone and fentanyl. Methadone, buprenorphine and naltrexone are the drugs commonly used for treating opioid addiction.

PNB VESPER Incorporated in 2011 and determined to discover drugs for serious diseases and unmet medical conditions. It is one of very few companies in India that is focused only on research-based NCEs, rather than generics. PNB VESPER was in the limelight at the time of Covid-19 pandemic. One of their molecule PNB 001 successfully completed phase 2 clinical trials in India with serious Covid 19 patients and DCGI approved phase 3 clinical trials. 
 
PNB VESPER’s products arise from Six programs, cholecystokinin receptors (CCK) that have been under development for more than a decade. The company has synthesized hundreds of molecules and systematically characterized them to select lead molecules. The lead molecules have the potential to treat a variety of diseases including pain, cancer, and inflammation such as inflammatory bowel disease (IBD), neurological diseases such as anxiety, and depression, metabolic diseases, and others. PNB VESPER’s assets are well protected by intellectual property filings both in the US and many other countries around the World.