Tryp Therapeuatics (TRYPF) Coverage Report
Exhibit 12: Dose-normalized plasma psilocin AUC and C max Dotted black line represents least squares regression. Source: Clin Pharmacokinet. 2017;56(12): 1543 Exhibit 13: Comparison of psilocin AUC and C max by weight Blue circles represent the observed AUC and C max in subjects; the dashed, black lines and grey shading show the least-squares fit and 95% prediction interval for the subject results following their psilocybin 0.3 mg/kg oral dose; and the solid black lines and green shading show the respective AUC and C max following the psilocybin 25 mg dose, based on the 500 simulations of the final pharmacokinetic model. Source: Clin Pharmacokinet. 2017;56(12): 1543 Psilocybin’s safety profile and abuse potential. For hallucinogens to become a part of mainstream mental health treatments, we believe the medical community, patients, payers and regulatory bodies will need to become comfortable that these medicines do not generate unnecessary risks. With their removal from mainstream medical care ~50 years ago, and a heightened risk of addiction and abuse from opioids, we consider hallucinogens’ abuse potential area of attention by the parties mentioned. Following our review, we have high confidence that there is little-to-no underlying potential for dependence or abuse of hallucinogens based on real world evidence (from NSDUH noted earlier and others) or the mechanism of action of hallucinogens. Research on abuse potential based on animal and human testing, along with real world evidence, has been widely shared among researchers and is provided in Exhibit 14. In rodent model assays, including intracranial self-stimulation (ICSS), a standard procedure to evaluate drug abuse liability, LSD, mescaline, and psilocybin have failed to generate detrimental effects (Biochem Pharmacol. 2008; 75(1): 17; Exp Clin Psychopharmacol. 2019; 27(3): 215; http://addictionscience.net/MARPADc01.htm) . Also, in the most recent Phase 3 clinical trial data for the use of MDMA-assisted psychotherapy Michael Higgins 212.409.2074 Tryp Therapeutics, Inc. (TRYPF) Page 20
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