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First in Human: LSD for ADHD; microbiomes for brain cancer; snake venom


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First in Human: LSD for ADHD; microbiomes for brain cancer; snake venom

This is a recurring column on clinical research in the early stages of development, which is referred to as phase 1. These are treatments being used for the first time in a small number of human patients to determine safety, dosing and general pharmacological activity.

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First came horse tranquilizer, sometime anesthetic and illegal party drug ketamine's surprising effectiveness in treating depression, and now LSD is being investigated to address mental health disorders. Mind Medicine (MindMed) Inc., the first publicly listed psychedelic pharmaceutical company, is embarking on an expanded trial of microdoses of the hallucinogenic drug in adults with attention deficit and hyperactivity disorder, or ADHD.

"I think we, as a company and as an industry, are pioneering a totally new asset class in the mental health space," co-founder and co-CEO JR Rahn said in an interview with S&P Global Market Intelligence. "What psychedelic-inspired medicines offer is an opportunity to look at the interconnectedness of mental health and I think traditionally, the typical pharmaceutical approach or drug development approach was to look at these indications in isolation," he said.

Rahn, who previously worked at tech companies like Uber Technologies Inc., said he is optimistic that Reno, Nev.-based MindMed, which went public in March on Toronto's NEO exchange, can overcome the stigma related to psychedelic drugs. Rahn set the company up after hearing anecdotal evidence from fellow executives in Silicon Valley that microdosing was helping them to stop using stimulant-based ADHD medications. He recruited Stephen Hurst, who had 40 years of experience in drug development, to be co-CEO.

MindMed is working on the clinical development of sub-hallucinogenic doses of psychedelic substances including LSD which was first discovered in 1938 by scientists at Sandoz, now the generics division of Novartis AG MDMA and ayahuasca, a hallucinogenic brew that originated in Peru, to treat a variety of mental health issues including adult ADHD, anxiety and substance abuse.

"I think the conversation needs to be transitioned from what is the substance to what is the potential outcome: if you could end anxiety, depression and addiction for much of America and the world, do you really care what that substance is?" said Rahn. He is optimistic that the U.S. Food and Drug Administration, which recently approved the first digital therapy for ADHD in children after a prolonged approval process, will give the green light to its LSD microdosing for the same condition in adults.

"I think that you will see a psychedelic-inspired medicine approved by the FDA before cannabis is federally legal in the United States."

Snake venom to reverse anticoagulation

VarmX BV, a biotech spin-out from Leiden University Medical Center, has raised €32 million in a series B financing round, backed by investors including LSP Life Sciences Fund NV and Lundbeckfonden Ventures, to develop a compound based on snake venom that reverses anticoagulation.

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VarmX is investigating whether snake venom can treat severe spontaneous bleeding.
Source: Wellcome Trust

The Leiden, Netherlands-based biotech was founded in 2016 by Pieter Reitsma, Professor Emeritus at Leiden and a leading expert in hemostasis and thrombosis, or the formation of blood clots. Proceeds from the fundraising will be used to start a first-in-human trial and to advance studies in both severe bleeding and emergency surgery indications. VarmX's lead compound, VMX-C001, is a modified recombinant blood factor X based on the venom of the Australian brown snake, Pseudonaja textilis. It is being developed to treat severe spontaneous bleeding in patients taking oral factor Xa inhibitors as anticoagulation therapy.

"They found that in that venom, the factor 10 that's present there is different than the factor 10 that's in other parts of the body of the snake," VarmX CEO Alexander Vos said in an interview with S&P Global Market Intelligence. "That particular factor 10 in the venom of that snake is insensitive to the factor of 10 A inhibitors and they connected the dots fairly quickly to understand that hey, if that's true, in that snake venom, let's try to figure out which sequence is responsible for that."

Over 10 million patients in the U.S. and Europe are treated with oral factor Xa inhibitors to prevent blood clots forming and leading to chronic indications like stroke or deep vein thrombosis. Each year, 2% to 3% of patients taking these medicines experience spontaneous and severe life-threatening bleeding, including a significant number who have to undergo emergency surgery, with the associated risk of bleeding.

Microbiome brain cancer drug advances with new funding

Enterome SA, a French biotech using the microbiome — the genetic material of microbes — to develop medicines, raised $52.6 million from investors, including Japan's Takeda Pharmaceutical Co. Ltd. The company will use the funds to launch phase 1 clinical trials of its lead compound EO2401 in glioblastoma an aggressive type of brain cancer and adrenal tumors.

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Enterome will test EO2401 in glioblastoma, a type of brain cancer.
Source: Stockvault

EO2401 is the first clinical candidate developed from Paris-based Enterome's OncoMimics platform. A second OncoMimics candidate, EO2463, is expected to start trials in 2021 for treating certain types of blood cancers, and Enterome is also working with Takeda on an experimental compound for Crohn's disease.

OncoMimics are microbiome-derived peptide antigens that closely mimic antigens expressed by tumor cells; they are selected based on their ability to trigger the rapid activation of memory T cells that respond to gut bacteria and to direct a targeted cell-killing immune response against the tumor. EO2401 combines three OncoMimics present in aggressive cancers, such as glioblastoma and adrenal malignancies.