Tonix Pharmaceuticals Expands Pipeline with Mid-Stage Biologic Candidate

Tonix Pharmaceuticals (NASDAQ:TNXP) has announced that it has in-licensed a Phase 2 asset, TNX-1300 for treating cocaine intoxication.

As quoted in the press release:

TNX-1300 is designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA).

TNX-1300, formerly RBP-8000, is a recombinant enzyme that efficiently degrades and metabolizes cocaine in cocaine abusers, as demonstrated in a Phase 2 randomized, double-blind, placebo-controlled clinical study, providing support of the use of TNX-1300 as a treatment for cocaine intoxication.¹

Currently there is no specific pharmacotherapy indicated for cocaine intoxication, a state characterized by acute agitation, hyperthermia, tachycardia, arrhythmias, and hypertension, with the potential life-threatening sequalae of myocardial infarction, cerebrovascular accident, rhabdomyolysis, respiratory failure, and seizures. Patients are currently managed only by supportive care for the adverse effects of cocaine overdose on the cardiovascular and central nervous systems. By targeting the cause of cocaine intoxication, rather than the symptoms like other medicines in emergency usage, we believe TNX-1300 may offer significant advantages to the current standard of care for cocaine overdose. TNX-1300 was developed by Columbia University, University of Kentucky and University of Michigan, and in-licensed by Tonix from Columbia University. Financial terms were not disclosed.

“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,” said Seth Lederman, M.D., 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.”

Click here to read the full press release.