New York City-based Tonix Pharmaceuticals announced it has in-licensed a Phase II drug, TNX-1300, from Columbia University. TNX-1300 is a recombinant enzyme that degrades and metabolizes cocaine in cocaine abusers.
New York City-based Tonix Pharmaceuticals announced it has in-licensed a Phase II drug, TNX-1300, from Columbia University. The drug, developed by Columbia University, the University of Kentucky and the University of Michigan, was developed for the treatment of cocaine intoxication.
There are no specific drugs approved for cocaine intoxication. TNX-1300 is a recombinant enzyme that degrades and metabolizes cocaine in cocaine abusers. It was produced via rDNA technology in a non-disease-producing strain of E. coli bacteria.
Cocaine Esterase (CocE) was found in the Rhodococcus bacteria and uses cocaine as its sole source of carbon and nitrogen and can grow in soil surrounding coca plants. The researchers identified the gene for CocE and the protein was extensively characterized.
CocE breaks down cocaine into ecgonine methyl ester and benzoic acid. The natural type of CocE is unstable at body temperature, so the researchers introduced mutations into the CocE gene, which resulted in the T172R/G173Q double-mutant CocE, which remains active at body temperature for about six hours.
In a Phase II clinical trial, the drug at 100 mg or 200 mg intravenous doses was well-tolerated and affected the cocaine symptoms after a 50 mg intravenous cocaine challenge.
“TNX-1300 is an excellent strategic fit within our focus on breakthrough psychiatry and non-opiate centrally-acting analgesic treatments and expands our pipeline into addiction treatment with a disruptive therapeutic technology in mid-stage clinical development,” stated Seth Lederman, Tonix’s president and chief executive officer. “TNX-1300 also represents our first in-licensed product, as we have historically developed products and technologies internally through our own discovery and R&D efforts. This transformative product meets our standards for innovation, value and impact.”
In April, Tonix announced that the U.S. Food and Drug Administration (FDA), which had rescinded Breakthrough Therapy designation for Tonmya (cyclobenzaprine HCL) for posttraumatic stress disorder (PTSD), had reversed the decision and granted the company a meeting in June to present more supporting data. The FDA’s original position was that “emerging data” on Tonmya for the HONOR clinical trial didn’t appear to support continuing the designation. At the June meeting, Tonix plans to present additional data and analysis related to HONOR and the AtEase study, which it believes will support continued Breakthrough Therapy designation.
The AtEase Phase II trial in military-related PTSD showed a substantial improvement over existing therapies. The Phase III RECOVERY trial in civilian and military-related PTSD began enrolling in March and Tonix expects topline data in the first half of 2020.
A day later, on April 22, Tonix announced it had received a notice of terminate, effective April 29, that the U.S. Army Medical Materiel Development Activity (USAMMDA) was exercising its contractual right to terminate the Collaborative Research and Development Agreement (CRADA) related to Tonmya for PTSD. The termination didn’t have any effect on Tonix’s finances or the RECOVERY trial.
The primary objective of the CRADA was for the USAMMDA to help Tonix in recruiting active duty military personnel for treatment into Phase II AtEase and Phase III HONOR of military-related PTSD. But, no patients were recruited from military treatment facilities (MTFs) into either study.
As the company and USAMMDA notes, the RECOVERY trial is only recruiting patients whose PTSD came about from trauma inflicted less than nine years before screenings. The largest deployment of U.S. troops into war zones in Iraq and Afghanistan took place more than nine years ago, so the number of potential trial participants was lower than in previous clinical trials.
