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HMNC: pioneering precision medicine for psychiatric care

HMNC Brain Health is aiming to shift the treatment approach in the psychiatric industry through the utilisation of precision medicine and compounds such as ketamine.



HMNC: pioneering precision medicine for psychiatric care

With the “one-size-fits-all” approach being the norm in the psychiatric industry, HMNC Brain Health is aiming to shake this up through targeted and personalised therapies powered by predictive diagnostics. 

Current mental healthcare treatment currently leaves a lot to be desired for some people, with an approximate 100 million people living with treatment-resistant depression (TRD) across the globe. In light of this, HMNC Brain Health wants to bring personalised care into mental health to meet this high, unmet need.

Professor Florian Holdboer worked for 30 years at the Max Planck Institute of Psychiatry before founding HMNC in 2010.

The company is aiming to innovate mental health care through the development of specific treatments with increased efficacy and reduced side effects, and will be harnessing genomics and Artificial Intelligence (AI) to develop them.

Earlier this year HMNC embarked on a joint venture with Develco Pharma to create the company Ketabon – a project developing a prolonged-release oral ketamine formulation for TRD.

A 30-year history in psychiatry

With Holdboer’s understanding of the link between mental health and genetics, he developed a very comprehensive asset portfolio comprising three compounds, treating both major depressive disorder as well as treatment-resistant disorder.

He also developed proprietary molecular diagnostic tests to identify those patients who would respond to treatments.

“Holdboer started to talk about precision medicine in mental health long before this became the standard in oncology,” said CEO, Benedikt Von Braunmuhl, speaking to Psychedelic Health.

“He was interested in how to treat depression and mental health disorders by selecting the right drugs for the right patients. His philosophy is that one-size-fits-all does not work, and mental health over the last few decades has not seen a lot of innovation. 

“There’s a high unmet medical need. A third of depression patients are treatment-resistant, which means that they are not responding to two consecutive treatments and this was exactly what his frustration was around. He tried to identify approaches to resolve that.”

Developing innovative treatments for unmet needs

HMNC’s ketamine programme has an investigator-initiated study ongoing at the University of Zurich in Switzerland, and the company hopes to see results soon.

Chief clinical development officer, Hans Eriksson, said: “We are developing targeted therapies for depressed people. We have three different clinical programmes in our portfolio right now which are all focused on depression. They are based on a selection of patients. 

“Two of these projects use genetic tests to select patients, and one of them is using more standard tests to select patients for treatment resistance. The Ketabon programme is built around ketamine, which has been around for many years as a dissociative anaesthetic. It has had lots of interest focused on its use at lower doses as an antidepressant. 

“There is no doubt that ketamine is an efficacious antidepressant but it has been difficult to get rid of the dissociative side effects that many patients experience as less pleasant. Those side effects plus the tendency towards a transient blood pressure increase has really affected the labels that regulators have applied to esketamine around the world, with the need for medical supervision.

See also  Ketamine and esketamine show no adverse cognitive effects

“We believe that we have the opportunity to maintain the good efficacy of ketamine but to decrease the tolerability issue. We are trying to do this by the use of an oral sustained release formulation that releases ketamine into the blood at a much lower rate than we see with the nasal spray and with the IV formulations.”

The compound has already been tested in both Phase I and Phase II studies in pain patients, which have indicated a good tolerability profile and no associated side effects or blood pressure increases. 

“Our aspiration is to bring the principle of ketamine to depressed patients, but without the tolerability issues,” added Eriksson.

“I’ve always been frustrated when I’ve seen the very wide variability of clinical presentations of depression, and everyone is diagnosed as having major depressive disorder. It seems so reasonable that there are different biologies at play here. Our absolute intention is to try to find these biologies and find specific interventions for them.”

Pioneering psychiatric care with precision medicine and ketamine

Current drugs in psychiatric care utilise mechanisms that were explored in the 50s, all developed with broad populations in mind. Some people respond well to these medications, but for those that don’t, it can be difficult to find hope in available care. 

HMNC’s two other projects centre around the hypothalamus-pituitary-adrenals axis (HPA axis), an important physiological mechanism in the human body. The HPA axis is often referred to as the stress access – as these organs are involved in the way the brain signals to the adrenals to produce the human stress hormone cortisol.

The company has now developed a compound – BH-200 – which specifically targets the dysfunction of the axis which it will use alongside a biomarker test. This type of testing is currently standard in areas such as oncology, for example, however, the development has yet to be utilised for mental health care. 

“As clinicians, we have never had the tools to find the patients who would respond exceedingly well. That means that we have had to fall into a sort of trial and error practice. If we could shortcut this and actually find the right medication at the earlier point in time, it will be very helpful for patients and also for society, because we will be able to get to the root of the disorder much faster,” said Eriksson.

“I think the wealth of data with ketamine is impressive. We believe that by using this oral ketamine, with a slow buildup of concentration, we will be able to reap the benefits of the antidepressant ketamine without having the problems. 

See also  What do recent ketamine findings mean for depression treatment?

“There has been a tremendous change in medical and psychiatric drug development over the last five to seven years. These medications that, at one point in time, were frowned upon and seen only as drugs of abuse are now being explored. It is a real Renaissance for more advanced psychopharmacology. I think this is probably the second golden age in psychopharmacology.”

Braunmuhl added: “That’s why I was so excited to join HMNC – when I saw this approach at the company and met the team I realised that this is the first company to do this in mental health.

“Everyone has a relationship to someone with a mental health disorder or even depression, and the stigma is becoming less problematic. People are talking about it more and realising that we have a solution.

“I think mental health will become the most important disease. For example, in 2030 depression is set to become be the most prevalent disease in the world, surpassing cancer. There is also the socio-economic impact of mental health disorders as a whole. If you look at the last few years, solutions are becoming more and more targeted and personalised.

“This is a tremendous opportunity for all of us here to contribute to the solution.”

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Psilocybin analogue shows positive results in Phase 2 depression study



Psilocybin analogue shows positive results in Phase 2 depression study

Cybin has announced positive Phase 2 topline safety and efficacy data for its proprietary deuterated psilocybin analogue – CYB003 – for the treatment of major depressive disorder (MDD).

Results from Cybin’s study have shown that 79% of patients were in remission from depression at six weeks after receiving two doses of CYB003.

CYB003 demonstrated a large improvement in symptoms after one dose and a total of 79% of patients were responsive to the treatment. The compound also demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self–limiting.

Additionally, Cybin has stated that the magnitude of improvement was superior compared to approved antidepressants and recently reported data with other psychedelics, stating that the effects translate into an unprecedented effect size.

The company has said that the results compare favorably to pooled data from 232 industry studies of current standard-of-care antidepressants, SSRIs, submitted to the FDA.

The announcement follows Phase 2 interim results in early November 2023, which demonstrated that CYB003 saw a “rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo”.

Cybin CEO, Doug Drysdale, stated: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.

“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month.”

Drysdale emphasised that the strength of the data will support CYB003 into Phase 3 of the study.

Cybin CMO, Amir Inamdar, added: “The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying.

“At the three-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS. 

“This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo. 

“These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg). 

“With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”

Cybin is planning on submitting topline data to the FDA with an aim to hold a Phase 2 meeting in Q1 of 2024, with further 12-week durability data from Phase 2 CYB003 expected in Q1, and recruitment for the Phase 3 study anticipated to begin by the end of Q1 2024.

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Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research



Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research

Mental health research provider Clerkenwell Health is calling for volunteers to join its groundbreaking clinical trials that will research whether psychedelics can provide effective treatments for complex mental health conditions.

Clerkenwell is seeking a diverse group of volunteers from across the UK between 18 and 65 years old to take part in the trials if they suffer from a relevant condition. 

The trials, which will be conducted at Clerkenwell Health’s purpose-built facility near Harley Street in London, are being run in partnership with a number of world-leading drug developers to test whether psychedelic drugs – often combined with talking therapy – can offer a new approach to treating a variety of mental health illnesses.

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

Clerkenwell Health is seeking volunteers for trials that look to find cures for a range of conditions, including PTSD, depression, alcohol use disorder and anorexia. 

Many of the conditions have few successful treatment options and Clerkenwell’s innovative methods of combining psychedelics with therapy aim to to treat these problems more holistically, providing long-term quality of life for patients.

Chief Scientific Officer at Clerkenwell Health, Dr Henry Fisher, said: “With the current system for treating mental health disorders simply not working, we’re calling for patients to help identify the next wave of treatments. 

“These have the potential to be groundbreaking for the millions of people across the UK who are affected by poor mental health.

“The status quo for mental health treatment has not only resulted in patients experiencing debilitating side-effects, huge waiting lists and high relapse rates, but is costly, complicated and broadly ineffective. 

“By participating in upcoming clinical trials, patients have an opportunity to make a valuable contribution to growing research which will support the development of the next generation treatments for mental health conditions.”

According to MIND, approximately 1 in 4 people in the UK will be affected by a mental health condition each year and with a significant rise in people contacting mental health services in recent years, there has never been a more desperate need to identify new and innovative treatments.

Given the challenges facing the country’s health service and with mental health challenges on the rise, the search for volunteers to test effective treatments has never been more pressing. 

Clerkenwell has stated, in this regard, that it has gone national with its search for volunteers in an effort to deliver medical breakthroughs in mental health akin to the Polio clinical trials in the 20th Century.

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Paper explores extended difficulties following psychedelic trips



Paper explores extended difficulties following psychedelic trips

A new paper has explored the extended difficulties experienced by some people following psychedelic drug use and discusses psychedelic harm reduction.

While multiple studies have shown that psychedelics can be safe when administered appropriately, some people experience difficulties following their use. These difficulties can last anywhere from a few days to years.

With a rise in clinical research surrounding these compounds, there is a drive to change drug policy and several places have already implemented progressive approaches to accessing these therapies such as decriminalisation or including them on authorised medical access schemes. 

In light of these developments, it is vital to understand the potential risks associated with psychedelic use and what actions can be taken to reduce these risks.

The paper has been published in Plos One and authored by a team of leading psychedelic scientists from the Universities of Exeter, Greenwich and Queen Mary, University College London and Royal Holloway, New York University and the Perception Restoration Foundation.

Extended difficulties following psychedelic use

The team of researchers has gathered data on the context of use, nature and duration of these difficulties and explored risk factors and perceived causes that may contribute to these experiences. 

The most common forms of extended difficulty that the team uncovered include symptoms such as anxiety/fear and existential struggle, as well as social disconnection, depersonalisation and derealisation.

“For approximately one-third of the participants, problems persisted for over a year, and for a sixth, they endured for more than three years,” the authors write.

The findings revealed that the length of time these experiences last following psychedelic use could be predicted by the participants’ knowledge of dose and drug type, and that the experiences were shorter if a participant had taken part in a guided psychedelic experience. 

Additionally, the most common length of time such difficulties lasted was between one and three years. When asked about mental illness onset following the psychedelic experience, 18.8% said they had gone on to be diagnosed with a mental illness, while 76.8% said they had not.

The authors write: “Our findings support the results of Simonsson et al., who found that anxiety was the most common enduring difficulty, based on quantitative questionnaire data and Bouso et al’s study of the Global Ayahuasca Survey, in which ‘feeling nervous, anxious or on edge’ was the second most common adverse mental health effect. Our findings also suggest that a Sense of disconnection from others was within the top five most prevalent themes, as did the studies by Simonsson et al. and Bouso et al. 

“Some extended adverse effects that were quite common in other studies weren’t so common in our data set–for example, feeling a harmful connection to the spirit world was reported by 14% of respondents to the Global Ayahuasca Survey but by less than 4% of our data set, which may suggest some forms of difficulty are particularly associated with certain psychedelic substances and/or their associated cultures.”

Reducing risk factors

The authors suggest a number of actions that could be taken to reduce these risks.

Highlighting that, as anxiety and fear are some of the most commonly reported difficulties, the authors suggest that all legal psychedelic experience providers give guidance on methods for “self-soothing and overcoming bouts of anxiety following the retreat, clinical trial or ceremony.”

Further suggestions include informing participants of potential harms and risks and advising participants that the integration process may take some time, and what practices can be done to help people cope with difficulties. The authors say these practices will be explored in an upcoming paper.

The team writes: “We envisage using the information in this study, and accompanying future papers that focus on social support and forms of coping used by those with enduring difficulties, to provide structured guidance and training to psychedelic retreats, therapists and clinical trial centers about the potential for adverse experiences, what the potential risk factors are and what can be done to help individuals who report such extended difficulties.”

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