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Harnessing digital therapeutics for ketamine patients

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Harnessing digital therapeutics for ketamine patients

Atai Life Sciences and Introspect Digital Therapeutics will be testing a novel, digital therapeutic approach for patients using ketamine for treatment resistant depression.

The clinical-stage biopharmaceutical company, atai Life Sciences, which aims to transform the treatment of mental health disorders, along with its digital therapeutic platform – Introspect Digital Therapeutics, Inc. – will be carrying out a usability study of Introspect’s digital therapeutic (DTx) app technology in supporting standard of care ketamine therapy for patients with treatment resistant depression.

The study will be carried out in collaboration with Kadima Neuropsychiatry. 

Digital therapeutics

Introspect’s DTx app approach to supported treatment in mental health will be integrated across three cohorts.

Cohort 1 will be focusing on user acceptability, Cohort 2 will be examining the introduction of therapeutic content via the app, and Cohort 3 will be assessing set and setting of the treatment.

The company says it believes that high-quality digital combination therapies have the potential to improve the safety and effectiveness of many mental health treatments, and that it considers DTx to be vital to the mission of providing personalised and scalable treatment to those who might not otherwise be able to access high-quality psychological care.

CEO of Introspect, David Keene, commented: “We’re thrilled to be working with Kadima to test our digital therapeutic approach in a clinical setting with patients receiving with standard of care ketamine therapy. 

“Our goal is to show that our novel DTx app can be used alongside a drug; that it is useful, usable and intuitive to patients and providers.”

See also  Majority in favour of changing law to boost psilocybin research in UK

“The integration of Introspect’s digital therapeutic in a clinical environment is a pivotal step towards developing potentially scalable care,” added Florian Brand, co-founder and CEO of atai. 

“In our mission to improve the lives of millions living with mental health disorders, technology will be instrumental, ensuring that our pipeline of novel compounds can benefit patients everywhere.”

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Top UK and European academics join Clerkenwell Health advisory board

Renowned academics in the field of psychedelics from leading European universities will be joining clinical research organisation Clerkenwell Health.

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Top UK and European academics join Clerkenwell Health advisory board

Clerkenwell Health is expanding its pan-European advisory board with the addition of Dr David Erritzoe, Dr Dea Siggaard Stenbæk, Dr Kim Kuypers and Dr James Stone from Danish, Dutch and British universities.

With psychedelic research flourishing in Europe, Clerkenwell Health says it is building connections between commercial research organisations and academic institutions. 

The expansion of its advisory board will give the company access to knowledge and networks from some of the most prestigious European universities – working to fulfil the company’s mission to create a more vibrant psychedelic clinical trial ecosystem and foster wider sharing of best practices across Europe.

Discover how Clerkenwell Health is developing a gold standard for psychedelic care

Chaired by Dr Henry Fisher, the Clerkenwell Health CSO, the board will focus on clinical research and therapy, with its new members bringing expertise in areas of psychotherapy, psychopharmacology, mental health, experimental medicine and psychedelics.

Speaking to Psychedelic Health, CEO of Clerkenwell Health, Tom McDonald, said: “The UK is an attractive location to undertake psychedelic drug development as the government are opening up innovation pathways and championing clinical research.

“We are excited to be joined in our work exploring psychedelics-assisted therapy here in the UK with leading experts from prestigious European universities. Their involvement ensures we have a variety of expert opinions to shape innovative trial designs whilst preparing a platform for European expansion in the coming years.”

See also  Clerkenwell Health is launching a free UK psychedelic therapist training programme

With an aim to support the commercial research ecosystem in the UK and Europe, the new board additions place Clerkenwell Health as an ideal partner to support drug developers wishing to conduct trials in European countries.

CSO of Clerkenwell Health, Dr Henry Fisher, stated: “I am delighted to be able to bring together such high calibre advisors into the Clerkenwell Health scientific advisory board. These researchers are leaders in their respective fields in Europe and are shaping the direction of clinical and fundamental research with psychedelics. 

“This gives us access to the knowledge and network built in some of the most prestigious universities from Copenhagen to Maastricht and London, and it is a privilege to be able to consult with these figures on our own research.”

Meet the advisory board

Dr David Erritzoe is clinical director and deputy head of the Centre for Psychedelic Research at Imperial College London.

Erritzoe is currently investigating brain mechanisms and therapeutic potential of MDMA, ketamine and classic psychedelics, and is clinical senior lecturer in general psychiatry in Centres for Neuropsychopharmacology and Psychedelic Research at Imperial, as well as consultant psychiatrist at St Charles Hospital, CNWL Mental Health NHS Foundation Trust. Erritzoe also heads a NHS-based research clinic at St Charles Hospital, the CIPPRes Clinic.

Dr Dea Siggaard Stenbæk is an associate professor at University of Copenhagen and Copenhagen University Hospital. 

Stenbæk’s research mainly focuses on neuropsychopharmacological effects of the 5-HT2A receptor agonist psilocybin. She collaborates with the Centre for Psychedelic Research at Imperial College London and is currently an honorary clinical research fellow in this group. As the clinical lead, she works on a study of psilocybin as a treatment for obsessive compulsive disorder.

Dr Kim Kuypers is an associate professor at Maastricht University. Her PhD focused on memory and risk-taking during MDMA intoxication. 

Kuypers’ main goal is to understand the neurobiology underlying flexible cognition, empathy and wellbeing. To accomplish this she uses a psychopharmacological model, studying the (sub)acute and longer-lasting effects of psychedelics on these behaviours and their underlying biology.

Dr James Stone worked as a clinical senior lecturer at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, with a focus on experimental medicine and clinical trials. 

During his time there, Stone set up the ketamine clinic at the Maudsley Hospital for patients with treatment-resistant depression. He also worked at Imperial College London as a senior lecturer, working as co-director of the intercalated BSc in neuroscience as well as continuing research into the role of glutamatergic abnormalities in psychosis.

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Psychedelics for addiction research gets $2.7m grant

The grant will fund research to investigate the efficacy of psychedelics for treating a variety of addiction disorders.

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Psychedelics for addiction research gets $2.7m grant

The University of California, Davis (UC Davis) and the University of Colorado Anschutz Medical Campus have received a $2.7m (~£2.15m) grant from the National Institute on Drug Abuse, part of the National Institutes of Health, to research psychedelics.

The researchers will use the funding to screen hundreds of compounds to discover new, non-hallucinogenic treatments for substance use disorders. 

With previous research having shown that psychedelic drugs can rewire parts of the brain involved in depression, substance abuse and post-traumatic stress disorder, David Olson, associate professor in the departments of Chemistry, and Biochemistry and Molecular Medicine at UC Davis, is searching for similar effects among compounds without the hallucinogenic effects of drugs like LSD. 

He calls these compounds psychoplastogens, for their ability to modify the brain.

See also  World’s first study on ketamine for behavioural addiction now complete

Olson commented: “I’m very excited that NIDA is recognising the potential that psychoplastogens might have for patients with substance use disorders.

“This grant will help us to understand the basic mechanisms by which these compounds impact addiction, and hopefully develop more effective and better-tolerated treatments.”

Olson’s work is part of a growing focus on psychedelics research at UC Davis and UC Davis Health. His lab has synthesised hundreds of molecules related to psychedelics in the search for new drug therapies. 

One such molecule, tabernanthalog, or TBG, produces both rapid and sustained anti-addictive effects in rodent models of heroin and alcohol self-administration.

The research will include mechanistic studies to understand how TBG impacts addiction and the development of new compounds with psychoplastogenic effects, he said. The team will use high-throughput screening to test for efficacy, safety and treatment potential. Promising compounds will undergo additional animal testing at CU Anschutz.

Delix Therapeutics, a startup founded by Olson, is also investigating non-hallucinogenic psychoplastogens for treating depression, anxiety and related disorders but is not involved in the project.

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Beckley Psytech strengthens leadership team as it progresses clinical pipeline

Dr Laura Trespidi has been appointed as chief development officer (CDO).

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Beckley Psytech strengthens leadership team as it progresses clinical pipeline

Dr Laura Trespidi is joining the Beckley Psytech leadership team as CDO, bringing more than 30 years’ experience in global pharmaceutical and biotechnology companies.

Trespidi will bring world-class leadership and technical expertise to the Beckley Psytech team, having worked across clinical product development and manufacturing, from pre-clinical research through to market approvals and global product launches. 

Trespidi will support the progression and development of Beckley Psytech’s investigational assets, including the proprietary formulations of intranasal 5-MeO-DMT, currently in Phase 1 studies.

See also  Beckley Psytech collaboration to develop next-gen psychedelic medicines

CEO of Beckley Psytech, Cosmo Feilding Mellen, said: “Dr Trespidi joins us as our chief development officer at an exciting time, with our lead drug candidates in Phase 1 clinical studies. Laura’s impressive track record and expertise across clinical development and manufacturing will be invaluable, as Beckley Psytech continues to grow and progress its clinical pipeline in this groundbreaking area of medicine.”

Trespidi’s former roles were placed at Summit Therapeutics and other leading companies such as Mundipharma, Shire Pharmaceuticals and GlaxoSmithKline. Most recently Trespidi worked as senior vice president of chemistry, manufacturing and controls (CMC), supply chain and technical operations at Summit Therapeutics, successfully leading global CMC and external manufacturing teams through the development and market preparedness of investigational medicines, including end-to-end supply chain and manufacturing readiness and expansion.

Trespidi’s expertise extends further to formulation development, technology transfers, outsourcing and offshoring, with additional experience developing and executing change management strategies. 

Throughout her career, Dr Trespidi has played a pivotal role in over 40 first-in-human clinical trials and pre-clinical trials, as well as contributing to four New Drug Applications (NDA) and market approvals, and over 40 Investigational New Drug (IND) applications.

Trespidi said: “I am thrilled to be joining Beckley Psytech at such a transformative time for the Company and for psychedelic medicines. 

“Beckley Psytech’s innovative pipeline has real potential to offer meaningful improvement to patients’ lives, and I am looking forward to working alongside a world-class team to turn this vision into a reality.”

Trespidi received her PhD in Pharmaceutical Science from the University of Milan, Italy; an MSc in Medicinal Chemistry and Biochemistry from the University of North Carolina, US; and in 2008 she received an M.B.A from the Open University Business School, UK. She has also authored a number of papers published in peer-reviewed journals and is a member of several scientific societies and associations.

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