Tonix Pharmaceuticals has announced a licensing deal with Katana Pharmaceuticals for its intranasal potentiated oxytocin to expand its use into metabolic disorders, in particular insulin resistance, diabetes, and obesity. The licensing deal is an addition to the company’s original purchase of oxytocin-potentiated therapy from Trigemina in June 2020, with preclinical data demonstrating the efficacy of the intranasal oxytocin product TNX-1900 in disorders of the central nervous system, with migraine chosen as the lead indication by Tonix.

The administration of therapies through oral or related methods, such as intranasal, is likely to be welcomed, as key opinion leaders (KOLs) interviewed by GlobalData have expressed the continuous challenge of patient compliance, in type 2 diabetes (T2D) patients for example, where many traditional drug classes consist of subcutaneously administered biological therapies. Where patients may be struggling with, or poorly adhering to, their subcutaneously administered therapy for T2D or other metabolic disorders, TNX-1900 could potentially improve compliance and obtain significant market share from subcutaneously and intravenously administered therapies.

The deal provides Tonix with exclusive rights to technology developed by the University of Geneva and held by Katana Pharmaceuticals, regarding oxytocin-based treatments. Studies from the University of Geneva have demonstrated the use of oxytocin in animal models leads to increased lipolysis and fatty-acid beta-oxidation, which led to improvements in lipid metabolism, glucose intolerance, and insulin resistance. Additional evidence around intranasal oxytocin includes weight reduction benefit, improved glucose homeostasis, and increased pancreatic beta-cell responsivity. With the evidence collected from these studies, Tonix believes that TNX-1900 may prove effective in addressing a variety of metabolic disorders.

There is a need for novel therapies that address the fundamental dysfunction that leads to the development of T2D, such as the decreased responsiveness of pancreatic-beta cells, as achieving optimal glycemic control with the current therapy regimens remains elusive to many patients. Obesity, common comorbidity and precursor of T2D, is increasing significantly, with GlobalData’s Pharma Intelligence Center Epidemiology database stating there will be 80.75 million sufferers of obesity by 2022 in the US market. With a critical need for therapeutics that induce weight loss, Tonix’s intranasal oxytocin has a significant opportunity to gain market share in the obesity and T2D disease space.

GlobalData predicts an intranasal administered therapy will be significant for the metabolic market and in particular T2D, where it can lead to improved compliance due to its route of administration and potential to improve glycemic control and beta-cell responsivity. This technology provides a novel opportunity for Tonix Pharmaceuticals to become a significant player in the T2D, obesity, and wider metabolic market, capturing significant market share from less-innovative market incumbents. There are increasingly novel therapeutics entering the metabolic pipeline, specifically with regard to T2D, where technologies are in development that will allow the oral delivery of therapies such as insulin and glucagon-like peptide-1 receptor agonists (GLP-1RAs). These include Biocon’s Phase III oral insulin tregopil, estimated to launch in 2022/2023, Oramed Pharmaceuticals’ Phase II oral insulin ORMD-0801, and Pfizer’s oral GLP-1RAs, Phase II PF-06882961 and Phase I PF-07081532.