Intec Pharma Advances Medical Cannabinoid Development Program With Dosing of First Patient in a Phase 1 Pharmacokinetic Study of Accordion Pill-THC
January 02, 2019 at 07:00 am EST
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Intec Pharma Ltd. announced the dosing of the first patient in a Phase 1 pharmacokinetic (PK) study of AP-THC, its proprietary Accordion Pill™ platform containing synthetic tetrahydrocannabinol (THC), one of the primary cannabinoids contained in cannabis. The Phase 1 PK study is a single-center, single-dose, randomized, open-label three-way crossover study to investigate the PK, safety and tolerability of AP-THC in up to 18 normal healthy volunteers. The Accordion Pill has the potential to address several major drawbacks of current methods of use and treatment with cannabis and cannabinoids, such as short duration of effect, delayed onset, variability of exposure, variable potency batch to batch, variability of the administered dose and adverse events that correlate with rate of rise and peak levels. An earlier Phase I trial of the Accordion pill formulated with plant derived THC and CBD together in a 1:1 ratio (AP-CBD/THC) compared the PK, safety and tolerability of two different AP formulations of AP-CBD/THC with Sativex® in 21 normal healthy volunteers. The results showed that patients in the AP- CBD/THC arm demonstrated significant improvements in the bioavailability of CBD (290% - 330%) and THC (25% - 50%) when compared with Sativex sublingual spray. The median time to reach peak THC concentration was 2-3 times longer with AP-CBD/THC as compared to Sativex. Importantly, the formation of THC metabolites was meaningfully reduced (>25%) and AP-CBD/THC was well tolerated with no serious adverse events reported. The Cannabis plant has traditionally been used for the treatment of chronic pain and a variety of other indications. Previous clinical studies conducted using the whole plant or specific extracts generated evidence of the cannabis analgesic activity. Furthermore, extracts containing known amounts of the active plant driven compounds (mainly THC and CBD) or diverse synthetic THC derivatives are thought to be promising treatments for painful conditions that do not respond well to currently available treatments, such as chronic, neuropathic and inflammatory pain.
Indaptus Therapeutics, Inc. is a clinical-stage biotechnology company, which specializes in cancer and viral infection treatments. The Companyâs approach is based on the hypothesis that activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Its technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The Company's lead clinical candidate is Decoy20. Its Decoy product candidates have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
INDAPTUS THERAPEUTICS, INC. 
