Check Up: US FDA approves the first clinical trial using naturally derived psychedelic drugs. Picture Getty Image
Health & Biotech
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.
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).
| 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 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.
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 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.
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.
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