PharmaDrug Inc. (CSE: BUZZ) (OTC Pink: LMLLF) has filed for an application with the U.S. Food and Drug Administration to receive Orphan Drug Designation (“ODD”) for N,N-Dimethyltryptamine or DMT in the prevention of ischemia-reperfusion injury in patients undergoing kidney transplantation.
The company explained that Ischemia/reperfusion injury (IRI) is caused by a sudden temporary impairment of the blood flow to a particular organ. PharmaDrug noted that research studies have shown that DMT activates the sigma-1 receptor (“Sig-1R”), an intracellular chaperone fulfilling an interface role between the endoplasmic reticulum and mitochondria in cells. Sig-IR ensures the correct transmission of ER stress into the nucleus resulting in the enhanced production of anti-stress and antioxidant proteins. “DMT has also been shown to have anti-inflammatory properties. Consistent with these functions, DMT was found to mitigate ischemia-reperfusion injury (IRI) caused by hypoxia, oxidative stress and inflammation in preclinical models of renal transplantation. The anti-inflammatory protective effects of DMT may provide a novel, more beneficial strategy to attenuate the damage induced by ischemia and reperfusion during kidney transplantation.”
“We have been focused on laying the foundation in becoming an industry leader in the research and development of novel uses for DMT in the treatment of neuropsychiatric, neurological and inflammatory disorders,” said Daniel Cohen, CEO of PharmaDrug. “Although DMT is commonly associated with offering an intense psychedelic experience, the therapeutic potential of DMT is fascinating and remains underexplored. We aim to unlock the potential of DMT in treating unmet medical needs beyond its potential utility in mental health disorders. Our orphan drug designation application for DMT in the prevention of kidney injury during transplant surgery fits with our psychedelic pharmaceutical strategy of creating a unique portfolio of DMT therapies targeting rare disorders while also focusing on foundational research with DMT to explore and evaluate its therapeutic potential both in the brain and other human organs.”
Earlier this month, PharmaDrug filed an application with the FDA to receive Orphan Drug Designation for DMT in the treatment of acute ischemic stroke patients presenting for emergency medical assistance within 3-hours of symptom onset.