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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.

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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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Evegreen

Psilocybin Shows Promise in Treating Obsessive-Compulsive Disorders: Is the Industry Getting Involved?

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A newly published systematic review titled on psilocybin’s effects on obsessive‑compulsive behaviours provides an up-to-date synthesis of research into the compound’s potential for treating OCD and related disorders. 

The study integrates findings from both animal models and early human trials, drawing attention to a consistent signal: reductions in obsessive or compulsive behaviours following psilocybin administration.

The review shows that in preclinical models (for example mice with altered grooming behaviours) psilocybin (or its active metabolite) produced marked reductions in compulsive-like behaviours, sometimes lasting beyond the immediate administration period. 

Clinically, although data remain limited, participants in early trials or case reports experienced rapid reductions in symptom severity (for example within hours or days) after single doses. The authors emphasise that while the mood-disorder applications of psilocybin are more advanced, this compulsive-behaviour indication is an important frontier.

In humans, single doses of psilocybin led to rapid symptom reductions. For example, in an open‑label study of nine treatment‑resistant OCD patients, reductions of 23 % to 100 % on the Y‑BOCS scale were recorded between 4 and 24 hours after dosing. A pilot trial in body dysmorphic disorder (a related OCRD) using a 25 mg psilocybin dose reported sustained improvements over 12 weeks in 58.3 % of participants. 

Mechanistically, the review highlights that psilocybin’s effects on compulsivity may not map exactly onto its classic psychedelic mechanism (5-HT₂A receptor activation). Some animal data suggest alternate or additional pathways (for instance 5-HT₇ receptor involvement, synaptic protein modulation) may underpin the anti-compulsive outcomes. The authors call for more robust, placebo-controlled human trials, ideally with neuroimaging and circuit-level biomarkers, to validate these early signals and clarify therapeutic protocols. 

The authors of the review emphasise that while the findings are promising, the evidence remains early stage. Key limitations include small clinical sample sizes, lack of placebo‑controls, short follow‑up intervals and heterogeneity in doses and models. They call for larger, double‑blind, placebo‑controlled trials incorporating neuroimaging of fronto‑striatal circuits, to more precisely map psilocybin’s effect in OCRDs. 

The authors propose that psilocybin may one day serve as a treatment for disorders characterised by repetitive, intrusive behaviours, not just mood disorders.

Are companies developing psilocybin-based treatments for OCD?

Several biotechnology companies are advancing psilocybin-based therapies for obsessive-compulsive disorder (OCD), signalling growing clinical interest in this area. 

Ceruvia Lifesciences has received U.S. FDA approval for an Investigational New Drug application to begin a Phase 2 trial using its synthetic psilocybin compound, SYNP-101, for OCD. The multicentre, randomised, double-blind, placebo-controlled study will administer a single oral dose and monitor participants for 12 weeks to assess symptom reduction, making it one of the most advanced OCD-focused psilocybin programmes.

Filament Health is developing PEX010, a botanical psilocybin drug exported to Israel for a trial investigating treatment-resistant OCD and PTSD.

MycoMedica Life Sciences lists OCD among its target indications, though its programmes remain early stage, while Compass Pathways is exploring broader psychiatric uses for COMP360, including potential applications in OCD.

Photo by Mélissa Jeanty on Unsplash.

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Markets & Industry

What Happens At A Legal Psychedelics Center? Psilocybin Clinic Publishes Real-World Data For The First Time

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For the first time, data from real-world application of psilocybin treatment under a regulated program was published by one of the Oregon clinics providing treatment.

In 2020, Oregon became the first U.S. state to legalize psilocybin for supervised therapeutic use when voters approved Measure 109. The law established a regulated framework for “psilocybin services” that include preparation, guided sessions, and integration support, administered at licensed service centers. The rollout has been gradual and cautious, given regulatory, safety, and infrastructure challenges. 

Until recently, much of what was known about psilocybin therapy outcomes came from controlled clinical trials; there was little insight into how the legal, real-world version would operate, who would access it, and whether the benefits observed in trials would translate to broader populations.

A fresh report by Osmind, one of the clinics providing the treatment, represent the first systematic look at real-world data emerging from Oregon’s legal psilocybin program under Measure 109, offering insights into demographics, motivations, safety, and self-reported mental health changes in participants.

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Who Is Accessing Psilocybin Services? 

From the “Real-World Evidence” report, data were gathered between March 2024 and April 2025 at a licensed service center in Central Oregon. Of 311 applicants, 88 individuals completed the baseline survey and became part of the analytic sample. 

Key demographic and background characteristics include:

  • Median age was 47 years; 62% female; 77% Caucasian; 63% holding a four-year college degree or more.
  • 16 % were veterans;  around 59% employed; 30% reported household income over $100K.
  • Prior experience: about 50% had used psychedelics before; about 50% were currently in counseling or therapy.

In terms of mental health, 61% identified depression as a primary concern, followed by anxiety (42%) and acute stress (24%). 

Many had complex, treatment-resistant histories and turned to psilocybin services after exhausting conventional options. Open-ended responses showed motivations spanning healing trauma, grief processing, managing obsessive or self-critical thoughts, and general desire for psychological insight or transformation.

This profile suggests that early adopters of Oregon’s program tend to be relatively educated, somewhat advantaged socioeconomically, and motivated by persistent mental health difficulties, not casual or recreational users. It also underscores gaps in diversity and access that future iterations of the program may need to address.

Outcomes, Safety & Changes in Mental Health Measures

The “Real-World Outcomes” report analyzed metrics across depression, anxiety, and subjective well-being using standardized tests to measure previous conditions and psychological state after the treatment in at a licensed service center. 

The findings were:

  • Depression (using the PHQ-8 scale): Mean reduction of 4.6 points, corresponding to a shift from moderate to mild severity
  • Anxiety (using the GAD-7 scale): Mean reduction of 4.8 points — a change exceeding commonly used clinical significance thresholds
  • Well-being (using the WHO-5 scale): Increase of 10.7 points, which is consistent with clinically meaningful improvement in mood and quality of life.

In terms of safety, there were no reportable serious adverse events in the 30-day follow-up period. 

However, about 3% of participants reported lingering negative effects (e.g. transient anxiety, existential distress, difficulties with family dynamics) at day 30.

These results mirror the direction of clinical trial evidence: meaningful decreases in depression and anxiety, and gains in well-being, but now observed in a legally regulated, real-world setting.

The Value of Real-World Evidence

These Osmind studies are groundbreaking because they offer the first empirical window into how a legalized psilocybin service model is functioning in practice. 

Clinical trials, while essential, often operate under narrow inclusion criteria, intensive controls, and short timeframes. They may not capture the full heterogeneity of “real-world” users, variations in implementation, or longer-term safety signals.

By contrast, these reports show how ordinary people (beyond trial populations) are using psilocybin services, what their motivations are, who they tend to be, and how their mental health measures shift in naturalistic settings. The absence of serious adverse events (in the short term) and the alignment of benefits with trial findings lend credibility to the possibility that psilocybin therapy could scale responsibly under regulation.

Furthermore, the data highlight access and equity issues (e.g. limited racial/ethnic diversity, relatively high socioeconomic status) that policymakers, providers, and regulators will need to contend with. As more jurisdictions consider legalizing or regulating psychedelics, having real-world evidence is critical for designing best practices, safety protocols, reimbursement models, and oversight. 

These early reports thus help close the gap between controlled trials and population-level rollout, and that alone makes them a major milestone in the evolving field of psychedelic medicine.

Picture by Photo by Timur Weber on Pexels.

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Medicinal

Royal College of Psychiatrists Calls for More Research into Psychedelics, Acknowledging Healing Potential

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On Friday, the Royal College of Psychiatrists has published a new report assessing the safety and efficacy of psychedelics and related substances as treatments for mental illness.

The College, which is the main professional organisation for psychiatrists in the United Kingdom, also issued guidance for clinical trials, emphasising that although early findings are promising, more robust evidence is needed before these substances can be adopted in routine psychiatric practice. 

Professor Owen Bowden-Jones, Registrar of the Royal College of Psychiatrists acknowledged the need for new treatments in the mental health space.

“New treatments are rarely developed for people with mental illness, whose needs are often overlooked, and it’s vital that this trend is reversed,” he said.

“That is why we are calling for further research into psychedelics as potential treatments for people with certain conditions, such as depression and PTSD, including those who are less responsive to other forms of care.” 

What is the Royal College of Psychiatrists and why its opinion matters

The RCPsych is the professional body responsible for psychiatry in the United Kingdom. It sets standards for psychiatric training, practice, education and research, accredits consultants and advises Government and regulatory bodies. Its judgements carry real weight for policy, clinical guidelines and funding. 

The College has previously issued comments on the use of psychedelics for mental health, but the Friday report marks the first comprehensive College-wide position on psychedelic and related substances for medical use.

What the report finds

The new RCPsych report reviews evidence for substances including LSD, psilocybin (also known as “magic mushrooms”), MDMA, ketamine, and others, both as standalone therapies and in combination with psychotherapy. Early studies suggest that these substances can have therapeutic potential in treating a range of mental disorders: anxiety disorders, depression, post-traumatic stress disorder (PTSD) and substance misuse.

The College concludes that, with the exception of ketamine (and esketamine, in certain cases), there is insufficient high-quality evidence to recommend these substances for routine clinical use. The report highlights gaps particularly in understanding long-term safety, risk profiles, and how best to integrate these treatments into existing therapeutic frameworks. 

Professor Oliver Howes, Chair of the College’s Psychopharmacology Committee, emphasised that the field is fast-moving, with risk of claims getting ahead of the evidence, and that more large, rigorous trials are needed.

Dr Jo O’Reilly, Chair of the Medical Psychotherapy Faculty, stressed the importance of the therapeutic relationship and proper supervision, noting that psychedelics can weaken psychological defences and bring forth traumatic material. Patients must be supported through preparation, during the altered state and through follow-up. 

“Psychedelics can have a profound effect on the mind and may make some people more responsive to psychotherapy. Patients often find their psychological defenses are lowered which allows traumatic and unpredictable material to emerge,” said Dr Jo O’Reilly.

The RCPsych acknowledging the therapeutic potential of psychedelics while insisting on more evidence marks a shift in the psychiatric field. It signals openness at high levels to new approaches, but also a strong insistence on scientific rigour, safety, and ethical oversight. 

Picture by Wikimedia Commons under Creative Commons license.

 

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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