Reset Pharma is addressing demoralization syndrome in patients suffering from cancer by bringing science to psilocybin.
What is demoralization syndrome?
Demoralization syndrome is a significant mental health condition characterized by loss of hope, purpose, and meaning in one’s life. It can occur in patients facing end-of-life progressive diseases such as cancer.1
Reset Pharma is uniquely focused on improving treatment outcomes in oncology
$250B
Estimated global oncology sales in 20242
$250K
Average cost of treatment course with modern cancer drugs3
Payers are focused on cost containment given the high cost of oncology treatments
Up to 50%
Of patients with cancer may develop demoralization syndrome in the absence of any other mood/anxiety disorder4
Demoralization syndrome is a significant, underserved issue1,4,5
>250K cancer patients
will develop demoralization syndrome every year in the absence of any other mood/anxiety disorder4,6
Zero approved treatments
exist for demoralization syndrome—patients are typically treated with antidepressants that have little effect4
Significantly increased risk of suicide
in people with demoralization syndrome4
“Those who gave up on life, who had lost all hope for a future, were inevitably the first to die.”
Victor E. Frankel
Auschwitz survivor and author of ‘Man’s Search for Meaning’
Demoralization syndrome is not depression
Demoralization syndrome (a morale-based disorder) is frequently mistaken for depression (a mood-based disorder), but there are distinct differences.4,5
Antidepressants have not been shown to be effective for the treatment of demoralization syndrome.4
Victor E. Frankel
Auschwitz survivor and author of ‘Man’s Search for Meaning’
The science of psilocybin
Psilocybin is a novel treatment pathway that holds the potential to deliver rapid, robust, and long-term improvements in people with demoralization syndrome.15-18
The promise of psilocybin
Prodrug
Psychedelic compound that comes from some species of mushrooms, which is converted into its active metabolite, psilocin19
Novel mechanism
Psilocin increases dopamine in the nucleus accumbens, impacting morale, but does not increase serotonin20
Proven potential
In an NYU Langone Health study, a single dose of psilocybin delivered fast (24 hours) and sustained clinical benefit (4.5 years) in demoralization syndrome for patients with cancer15,16
Reset Pharma is developing a commercially differentiated, proprietary drug product (RSTP-1000) with strong IP protections
Victor E. Frankel
Auschwitz survivor and author of ‘Man’s Search for Meaning’
References
1. Robinson S, Kissane, DW, Brooker J, et al. A systematic review of the demoralization syndrome in individuals with progressive disease and cancer: a decade of research. J Pain Symptom Manage. 2015;49(3):595-610. doi:10.1016/j.jpainsymman.2014.07.008
2. Albrecht B, Alfano S, Keane H, Yang G. Delivering innovation: 2020 oncology market outlook. McKinsey & Company. September 2020.
3. Health Affairs Blog. New cancer therapies are great—but are they helping everyone?. Health Affairs Forefront. April 12, 2019. Accessed May 25, 2023. https://www.healthaffairs.org/content/forefront/new-cancer-therapies-great-but-they-helping-everyone
4. Vehling S, Kissane DW, Lo C, et al. The association of demoralization with mental disorders and suicidal ideation in patients with cancer. Cancer. 2017;123(17):3394-3401. doi:10.1002/cncr.30749
5. Jacobsen JC, Maytal M, Stern TA. Demoralization in medical practice. Prim Care Companion J Clin Psychiatry. 2007;9(2):139-143. doi:10.4088/pcc.v09n0208
6. American Cancer Society. Cancer facts and figures 2023. Atlanta: American Cancer Society. 2023.
7. De Figueiredo JM. Depression and demoralization: phenomenologic differences and research perspectives. Compr Psychiatry. 1993;34(5):308-311. doi:10.1016/0010-440x(93)90016-w
8. Tang P, Lin H, Wang H, Hu L, Chou F. Demoralization level fluctuated at various time frame of radiotherapy for patients with different cancers: a longitudinal observational study. BMC Palliat Care. 2022;21:143. doi:10.1186/s12904-022-01033-z
9. Leach J. ‘Give-up-itis’ revisited: neuropathology of extremis. Med Hypotheses. 2018;120:14-21. doi:10.1016/j.mehy.2018.08.009
10. Feder A, Nestler EJ, Charney DS. Psychobiology and molecular genetics of resilience. Nat Rev Neurosci. 2009;10(6):446-457. doi:10.1038/nrn2649
11. Gan LL, Gong S, Kissane DW. Mental state of demoralisation across diverse clinical settings: a systematic review, meta-analysis and proposal for its use as a ‘specifier’ in mental illness. Aust N Z J Psychiatry 2022;56(9):1104-1129. doi:10.1177/00048674211060746
12. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association; 2013.
13. Singh T, Williams K. Atypical depression. Psychiatry (Edgmont). 2006;3(4):33-39.
14. Duan S, Lawrence A, Valmaggia L, Moll J, Zahn R. Maladaptive blame-related action tendencies are associated with vulnerability to major depressive disorder. J Psychiatr Res. 2022;145:70-76. doi:10.1016/j.jpsychires.2021.11.043
15. Ross S, Bossis A, Guss J, et al. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. J Psychopharmacol. 2016;30(12):1165-1180. doi:10.1177/0269881116675512
16. Agin-Liebes GI, Malone T, Yalch MM, et al. Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. J Psychopharmacol. 2020;34(2):155-166. doi:10.1177/0269881119897615
17. Griffiths RR, Johnson MW, Carducci MA, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016;30(12):1181-1197. doi:10.1177/0269881116675513
18. Grob CS, Danforth AL, Chopra GS, et al. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Arch Gen Psychiatry. 2011;68(1):71-78. doi:10.1001/archgenpsychiatry.2010.116
19. Lehto RH, Miller M, Sender J. The role of psilocybin-assisted psychotherapy to support patients with cancer: a critical scoping review of the research. J Holist Nurs. 2022;40(3):265-280. doi:10.1177/08980101211039086
20. Sakashita Y, Abe K, Katagiri N, et al. Effect of psilocin on extracellular dopamine and serotonin levels in the mesoaccumbens and mesocortical pathway in awake rats. Biol Pharm Bull. 2015;38(1):134-138. doi: 10.1248/bpb.b14-00315
