• US FDA approves the first clinical trial using naturally derived psychedelic drugs
  • It could open possibilities for other clinical trials to follow suit
  • Best and worst biotechs over the past month

In a ground-breaking development, the US FDA has just approved a clinical trial studying the effects of naturally derived psychedelic drugs.

The phase one clinical trial, conducted at the University of California, is the first to directly administer psilocin and psilocybin derived from real mushrooms, as opposed to lab-created synthetic substances.

Specifically, the trial will investigate three proprietary botanical drug candidates owned by Filament Health, a biotech company listed on the Neo Exchange in the US.

The drug candidates are naturally extracted and stabilised forms of the psychedelic compounds found in certain mushrooms.

The trial objective is to compare the physiological and psychological effects of orally administered psilocybin, orally administered psilocin, and sublingually administered psilocin among healthy adults over a series of exposures.

Dr. Joshua Woolley, the study’s Principal Investigator, said the trial will provide crucial information about the effects and mechanisms of these compounds that could allow for greatly enhanced psychedelic-assisted therapy.

First steps in a long trip

This is an important step forward because all previous trials had relied on lab-made versions to ensure consistency and purity of the compounds

Although experts say that pure synthetic psilocybin is chemically no different than pure naturally-derived psilocybin, using naturally derived ones may have potential benefits.

For example, pure natural psilocybin contains additional sub metabolites extracted from the magic mushroom, which many believe may offer a potential ‘entourage effect’.

In medicinal cannabis, the entourage effect is a mechanism by which cannabis compounds other than tetrahydrocannabinol (THC) act synergistically with it to modify the overall psychoactive effects of the plant.

Using a naturally extracted psilocybin also has psychological effects, according to experts, as people tend to prefer anything natural.

Some ASX companies will be keen to watch this development very closely.

ASX companies in the psychedelic space include:

Emyria (ASX:EMD), Incannex Healthcare (ASX:IHL), Creso Pharma (ASX:CPH), and Little Green Pharma (ASX: LGP).

Best and worst performing ASX biotechs in the past week

CODE COMPANY PRICE 1 WEEK RETURN % 1 MONTH RETURN % 1 YEAR RETURN % MARKET CAP
EXL Elixinol Wellness 0.053 51% 112% -56% $16,129,544.12
1ST 1St Group Ltd 0.009 50% 80% -55% $11,593,564.34
AGH Althea Group 0.135 47% 96% -59% $43,368,460.83
TRP Tissue Repair 0.34 36% 42% 0% $15,671,418.93
BXN Bioxyne Ltd 0.017 31% 31% -41% $10,882,471.77
M7T Mach7 Tech Limited 0.71 26% 42% -26% $164,789,973.12
ADR Adherium Ltd 0.01 25% 25% -44% $19,874,259.83
RNO Rhinomed Ltd 0.175 25% 30% -16% $45,715,151.04
RAD Radiopharm 0.2375 25% 48% 0% $26,128,668.50
RAD Radiopharm 0.2375 25% 48% 0% $26,128,668.50
IMU Imugene Limited 0.28 24% 100% -14% $1,554,410,485.43
ZLD Zelira Therapeutics 2.45 24% 145% -71% $25,858,213.20
CPH Creso Pharma Ltd 0.048 23% 17% -66% $59,638,675.84
CMP Compumedics Limited 0.19 23% 19% -51% $35,432,589.60
AHK Ark Mines Limited 0.19 23% -27% 459% $6,039,268.03
S66 Star Combo 0.19 23% 27% -34% $20,925,462.06
RHY Rhythm Biosciences 1.45 22% 38% 43% $302,926,235.18
CHM Chimeric Therapeutic 0.14 22% 54% -52% $38,756,487.63
CBL Control Bionics 0.23 21% 84% -63% $11,576,108.38
MVP Medical Developments 2.2 18% 31% -47% $137,618,760.01
IIQ Inoviq Ltd 0.59 18% 36% -68% $54,291,034.18
IVX Invion Ltd 0.0105 17% 31% -25% $64,165,136.44
TD1 Tali Digital Limited 0.007 17% 0% -79% $7,395,783.14
ALC Alcidion Group Ltd 0.1325 15% 20% -62% $158,508,631.63
AHC Austco Healthcare 0.13 13% 40% -7% $37,321,136.97
CU6 Clarity Pharma 0.595 12% 37% 0% $110,466,500.64
EPN Epsilon Healthcare 0.038 12% 65% -74% $9,133,452.30
AC8 Auscann Grp Hlgs Ltd 0.048 12% 9% -54% $20,705,714.17
MXC Mgc Pharmaceuticals 0.02 11% 0% -50% $51,837,583.19
VHT Volpara Health Tech 0.575 11% 20% -50% $137,304,619.15
CAN Cann Group Ltd 0.32 10% 19% -14% $110,068,937.37
MDR Medadvisor Limited 0.16 10% 14% -47% $55,214,541.16
CGS Cogstate Ltd 1.665 10% 6% 22% $285,190,904.50
LDX Lumos Diagnostics 0.056 10% -61% -95% $12,174,573.87
PTX Prescient Ltd 0.17 10% 0% -19% $107,963,303.75
IMC Immuron Limited 0.099 9% 10% -38% $22,552,036.25
ALA Arovella Therapeutic 0.025 9% 4% -56% $15,406,210.20
CYP Cynata Therapeutics 0.39 8% 4% -22% $55,161,488.69
HCT Holista CollTech Ltd 0.042 8% 24% -28% $11,648,661.65
DXB Dimerix Ltd 0.145 7% 4% -40% $48,131,049.90
NEU Neuren Pharmaceut. 4.17 7% 19% 162% $521,497,898.64
ILA Island Pharma 0.155 7% 29% -53% $6,703,180.84
NOX Noxopharm Limited 0.235 7% 12% -62% $67,214,728.50
ATH Alterity Therap Ltd 0.016 7% 0% -53% $38,509,993.25
PNV Polynovo Limited 1.57 6% 18% -26% $982,606,745.34
NTI Neurotech Intl 0.071 6% 29% 27% $48,838,938.82
PXS Pharmaxis Ltd 0.073 6% -1% -11% $37,886,393.25
RSH Respiri Limited 0.056 6% 65% -15% $42,663,395.38
ARX Aroa Biosurgery 0.79 5% 14% -35% $253,615,913.92
IBX Imagion Biosys Ltd 0.042 5% 56% -52% $44,848,741.36
AT1 Atomo Diagnostics 0.067 5% 8% -65% $36,537,023.42
MVF Monash IVF Group Ltd 1.0625 5% 15% 26% $409,116,582.00
TLX Telix Pharmaceutical 5.62 4% 38% 11% $1,758,589,836.42
OPT Opthea Limited 1.2 4% 15% -4% $415,539,999.56
BOT Botanix Pharma Ltd 0.073 4% 20% -4% $70,504,803.65
AVE Avecho Biotech Ltd 0.0125 4% -4% -38% $22,972,656.58
CYC Cyclopharm Limited 1.525 4% 45% -9% $142,396,605.08
ACW Actinogen Medical 0.053 4% 4% -52% $93,386,478.48
SDI SDI Limited 0.85 4% 6% -3% $101,035,700.50
EZZ EZZ Life Science 0.29 4% -3% -33% $3,700,400.00
IMM Immutep Ltd 0.325 3% 5% -36% $281,527,939.88
OIL Optiscan Imaging 0.1 3% -13% -57% $61,340,954.60
PIQ Proteomics Int Lab 0.875 3% 7% -15% $92,534,446.38
OSX Osteopore Limited 0.18 3% 33% -58% $21,108,282.84
ADO Anteotech Ltd 0.078 3% 10% -66% $149,090,610.15
ICR Intelicare Holdings 0.041 3% 3% -77% $5,420,983.82
BDX Bcaldiagnostics 0.084 2% 18% 0% $11,228,050.35
IHL Incannex Healthcare 0.21 2% -22% -24% $262,878,475.74
ANP Antisense Therapeut. 0.085 2% 1% -56% $53,503,518.24
PAA Pharmaust Limited 0.092 2% 15% -4% $27,254,464.94
PGC Paragon Care Limited 0.27 2% -13% -7% $180,395,115.88
PBP Probiotec Limited 2.29 2% 2% 11% $186,230,599.74
UBI Universal Biosensors 0.34 1% 0% -56% $70,967,885.73
4DX 4Dmedical Limited 0.495 1% 24% -67% $101,343,545.06
VTI Vision Tech Inc 0.3025 1% 21% -74% $7,456,778.37
ALT Analytica Limited 0.0015 0% 50% -40% $6,920,701.69
AMT Allegra Orthopaedics 0.18 0% 0% -10% $18,802,656.54
TSN The Sust Nutri Grp 0.14 0% 0% -64% $16,884,893.90
HXL Hexima 0.012 0% -96% -94% $1,916,865.01
SCU Stemcell United Ltd 0.014 0% 0% -22% $14,696,980.89
HGV Hygrovest Limited 0.063 0% -2% -24% $14,487,101.06
MEB Medibio Limited 0.002 0% -33% -75% $5,512,980.23
JTL Jayex Technology Ltd 0.005 0% -29% -83% $1,246,142.70
ICS ICSGlobal Limited 0.575313 0% 0% 0% $6,054,604.94
FFC Farmaforce Ltd 0.035 0% 0% -48% $4,573,834.30
AN1 Anagenics Limited 0.033 0% 27% -44% $7,293,703.00
OVN Oventus Medical Ltd 0.02 0% 0% -82% $4,834,530.70
GLH Global Health Ltd 0.3 0% 15% -43% $17,844,676.61
GTG Genetic Technologies 0.004 0% 33% -56% $32,318,878.00
DVL Dorsavi Ltd 0.011 0% 10% -61% $3,921,368.57
BPH BPH Energy Ltd 0.013 0% -13% -82% $7,979,379.01
NSB Neuroscientific 0.2 0% 5% -39% $28,694,328.60
PAL Palla Pharma Ltd 0.295 0% 0% -20% $47,764,383.09
1AD Adalta Limited 0.048 0% -4% -64% $15,080,867.81
OSP Osprey Med Inc 0.2 0% 0% -86% $5,131,708.40
LCT Living Cell Tech. 0.008 0% 0% -40% $10,282,909.78
RCE Recce Pharmaceutical 0.795 -1% 35% -17% $142,117,528.00
CTE Cryosite Limited 0.62 -1% -9% 55% $30,261,929.06
PAR Paradigm Bio. 1.035 -1% 4% -47% $230,282,582.57
SOM SomnoMed Limited 1.18 -2% -4% -49% $97,655,991.70
OSL Oncosil Medical 0.059 -2% 26% -2% $59,474,535.72
VLS Vita Life Sciences.. 1.945 -2% 4% 83% $104,681,095.64
RAP Resapp Health Ltd 0.1325 -2% -24% 201% $120,357,590.78
TRU Truscreen 0.049 -2% 11% -23% $17,780,446.40
MEM Memphasys Ltd 0.037 -3% 6% -47% $29,310,598.47
RHT Resonance Health 0.07 -3% 23% -59% $31,337,934.71
DOC Doctor Care Anywhere 0.175 -3% 17% -79% $38,627,418.70
NC6 Nanollose Limited 0.078 -3% 20% -10% $11,017,591.23
ZNO Zoono Group Ltd 0.155 -3% 7% -78% $26,625,872.80
IDT IDT Australia Ltd 0.15 -3% 30% -53% $39,768,596.51
BWX BWX Limited 0.705 -3% -39% -86% $127,776,504.08
IPD Impedimed Limited 0.056 -3% -18% -47% $97,899,139.75
CAJ Capitol Health 0.275 -4% -2% -25% $286,609,815.80
ONE Oneview Healthcare 0.135 -4% 4% -63% $72,610,370.42
OCC Orthocell Limited 0.385 -4% 20% -27% $77,865,525.64
CDX Cardiex Limited 0.385 -4% 17% -44% $42,351,424.50
RAC Race Oncology Ltd 2.14 -4% 40% -39% $334,991,542.20
VBS Vectus Biosystems 0.9 -4% -18% -33% $32,639,542.20
PYC PYC Therapeutics 0.064 -4% -10% -57% $203,579,270.59
BIT Biotron Limited 0.064 -4% -6% 8% $43,519,828.21
GSS Genetic Signatures 1 -5% -4% -26% $140,518,276.08
PSQ Pacific Smiles Grp 1.78 -5% 3% -28% $278,470,481.81
MDC Medlab Clinical Ltd 0.08 -6% 45% -50% $26,689,702.34
NXS Next Science Limited 0.78 -6% 8% -51% $163,240,501.84
NYR Nyrada Inc. 0.155 -6% 11% -46% $25,741,435.50
SHG Singular Health 0.092 -6% -3% -69% $6,006,594.35
IRX Inhalerx Limited 0.07 -7% -9% -30% $11,792,686.99
PCK Painchek Ltd 0.028 -7% -20% -52% $35,953,423.96
LBT LBT Innovations 0.083 -7% 11% -28% $26,551,828.15
ACR Acrux Limited 0.053 -7% -17% -59% $14,838,962.79
EYE Nova EYE Medical Ltd 0.19 -7% 3% -37% $27,660,160.29
PAB Patrys Limited 0.023 -8% 10% -53% $47,310,994.41
BNO Bionomics Limited 0.055 -8% 0% -71% $78,494,343.15
MX1 Micro-X Limited 0.14 -10% 12% -56% $64,603,597.24
RGS Regeneus Ltd 0.053 -10% 0% -29% $16,241,156.44
KZA Kazia Therapeutics 0.545 -11% -27% -57% $69,664,373.00
ATX Amplia Therapeutics 0.098 -15% 3% -53% $19,012,542.53

Tissue Repair (ASX:TRP)

Tissue Repair rose after submitting a Type C Meeting request with the FDA which, if endorsed, will provide clarity for the company to progress into a Phase III clinical program for its lead drug candidate TR-987.

At the meeting, Tissue Repairs will seek to clarify a broad set of matters required to facilitate progression into the trial program.

Should the FDA endorse the plans, program and recommendations contained in this meeting request, the company should have sufficient clarity on the substantive items required to obtain Phase III clinical trial approval early in 2023.

Adherium (ASX:ADR)

The respiratory eHealth company announced it has signed a distribution agreement for US patient monitoring with Perigon Health to sell the Hailie platform.

Perigon’s world-class proprietary platform, Medesto, is an enterprise drug and therapy monitoring platform that consolidates remote monitoring services into one portal.

Adherium’s Hailie digital product portfolio has now been incorporated into Perigon’s Medesto drug and therapy monitoring platform.

Rhinomed (ASX:RNO)

Rhinomed has finalised an exclusive supply agreement with SureScreen Australia to supply Rhinoswabs and Rhinoswab Juniors for inclusion in SureScreen’s range point of care test kits.

This covers markets in Australia, New Zealand, Singapore and the South Pacific.

The first product to market will be the ARTG registered SureScreen SARS-CoV-2 Antigen Rapid test Cassette Gold for children, which features Rhinomed’s novel Rhinoswab Junior.

This will be the first SARS-CoV-2 rapid antigen test kit designed specifically for children aged 4-12 on the Australian market.

Radiopharm Theranostics (ASX:RAD)

Radiopharm has extended its agreement with global oncology provider GenesisCare, who will support a second Radiopharm clinical trial in Australia.

The trial will use Radiopharm’s PSA targeting antibody to start a therapeutic Phase 1 in prostate cancer, with an expected commencement in the coming months.

Discovered by Professor David Ulmert, previously at Memorial Sloan Kettering and now UCLA, the proprietary monoclonal antibody is capable of targeting free human prostate kallikrein (PSA) in prostate cancer cells.

Imugene (ASX:IMU)

New data from non-small cell lung cancer patients in Imugene’s Phase I IMPRINTER trial has been selected for a poster presentation at the IASLC 2022 World Conference on Lung Cancer (WCLC) taking place from 6-9 August in Vienna.

WCLC is the world’s largest international gathering of clinicians, researchers and scientists in the field of lung cancer and thoracic oncology.