Inside Toronto’s Newest Psychedelics Clinic

INN visited Field Trip Health’s Toronto space to get a closer look at the clinic business model for the burgeoning psychedelic drug industry.

As investors latch onto the promise of psychedelic medicines, clinics and the clinic network management business are poised to take on a major role in the psychedelics investment story.

These clinics, which offer legally available psychedelic treatments to patients, are just one segment of the broad psychedelics market. The companies operating them are aiming to become hubs for the administration of psychedelic treatments and want to transform the perception of these drugs.

Currently, most clinics provide therapies based on the use of ketamine as an agent that launches an in-depth drug trip for patients looking for relief from mental health conditions like anxiety or depression.

One of these new clinics opened its doors to the Investing News Network (INN) as a way for investors to get a closer look at the business proposition.

Field Trip Health launched its first ketamine treatment clinic, located in Toronto, back in March — just days before Canada went into lockdown due to the novel coronavirus. The clinic was deemed an essential service and has continued to see patients with established health precautions in place.

With all regulations in place, INN spoke with some of the staff at the clinic and got a firsthand look at the path patients take inside.

Taking a look inside Field Trip’s ketamine clinic

Located on the edge of the Entertainment District in downtown Toronto, the Field Trip clinic looks like a modern office environment at first glance.

Opening into a wide space of waiting areas all leading to the therapy rooms, the clinic blends new wave decor and neon lighting. It’s full of greenery and has a view of the city in motion at a busy corner.

Inside the actual therapy rooms though there is no city commotion. Patients are guided during their trips with the help of customizable mood lighting, noise-canceling headphones, eye covers and even weighted blankets. The intention is to make patients feel as relaxed as possible.

therapy room at Field Trip Health's ketamine clinic

The therapy room where patients go through their ketamine drug trips at the Field Trip clinic. Photo by Bryan Mc Govern.

The ketamine is administered by clinic staff via a dissolvable component ingested by the patient.

Canada defines ketamine as an anesthetic drug for medical use that produces a dissociation from the body by the mind of the user. While the drug is deemed as a controlled substance under the Controlled Drugs and Substances Act, the country views it as having “legitimate uses in medicine.” Only authorized operations may legally sell, possess or produce ketamine.

Sabina Pillai, registered psychotherapist with Field Trip, said since the clinic opened there’s been a wide mix of patients in terms of newcomers to the world of psychedelics and those with significant experience.

The team at the clinic aims to set all patients at ease, regardless of their previous experience with psychedelics, in order to enhance their drug trips. Pillai said every trip is different, but if patients go into the experience with an “open mind” the results will be better.

Pillai is one of the clinic workers who’s tasked with staying alongside patients throughout their trips. The psychotherapist told INN that based on the wide variety of possible reactions, it’s better to have an expert inside the room. According to Pillai, the range in reactions goes anywhere from joy and happiness to frustration or disappointment given the weight of the introspective trip.

“It’s empowering for us,” Sharon Bella, respiratory therapist at the Toronto location of Field Trip, said of being a participant in the patient treatment process using ketamine.

waiting room at Field Trip Health's clinic

The Field Trip clinic has space for patients to relax before and after their sessions. Photo by Bryan Mc Govern.

Referral process for Field Trip’s clinic

Before any patient goes to the Field Trip clinic, they must be referred by their psychiatrist. Then the Field Trip team will evalute the patient and determine if ketamine-based treatment truly is the best option.

Ronan Levy, founder and executive chairman of Field Trip, previously told INN the program includes six ketamine treatment sessions in addition to six therapy sessions and three integration therapy sessions.

According to the executive, the entire course will cost a patient C$4,700. Levy said the price tag is on par with high-end psychotherapy, given that each session costs an average of C$250 to C$300. While no insurance currently offers coverage, there are split payment options available for patients.

The actual ketamine sessions can last between 45 and 90 minutes, and every time a patient goes on a drug trip they debrief with a psychotherapist after.

Monica Mina, nurse practitioner with Field Trip, worked at a traditional hospital before joining the psychedelics space. Like Pillai, Mina told INN it is helpful for patients to have an open mind to this method of treatment.

therapy room at Field Trip Health's ketamine clinic

Patients at the Field Trip clinic have ample ways to relax before experiencing their trip, including weighted blankets. Photo by Bryan Mc Govern.

Expanding the Field Trip brand in North America

The management team of Field Trip doesn’t want to stop just with Toronto. Before the effects of the pandemic took root, the firm was in the process of opening new locations in New York and Los Angeles. Overall, the psychedelics company envisions opening 75 locations in North America, but for now its flagship Toronto location represents the only clinic for Field Trip.

“There’s going to be a very common and uniform Field Trip brand experience,” Levy said of the planned psychedelic treatment clinic network.

The executive said the plan is for treatment options at the clinics to remain consistent. However, there may be tweaks in the future, depending on the future availability of legal psychedelic treatments.

“As unique opportunities emerge, we may incorporate different offerings into different clinics starting on a trial basis to see how effective they are and whether there’s a lot of demand for those kinds of services,” Levy told INN.

The clinic from Field Trip isn’t the first of its kind in the city, since the Canadian Rapid Treatment Center of Excellence (CRTCE) opened to patients looking for ketamine treatments back in 2018. Dr. Roger McIntyre, who leads Champignon Brands (CSE:SHRM,OTCQB:SHRMF) as its CEO, opened the CRTCE clinic.

waiting area at the Field Trip Health's clinic in Toronto

Some of the unique design choices at the Field Trip clinic in Toronto. Photo by Bryan Mc Govern.

Field Trip considering options for going public

Investors looking to add psychedelics names to their portfolios are starting to see a run of new listings hitting the market thanks to the growing positive sentiment surrounding this market.

And it’s not hard to see why  — in a market report, drug research firm Prohibition Partners indicates: “Psychedelics could be used in the treatment of PTSD and depression — issues that are affecting millions of people across the globe with growing rates of prevalence.” Early projections are placing a US$7 billion value on the entire psychedelics industry by the year 2027.

In light of the recent success stories seen from psychedelics firms going public, the question circling Field Trip has been: When does the firm anticipate going public?

The company completed a US$8.5 million raise back in February, which Levy previously told INN is still mostly available. Field Trip’s expenses faced a halt once COVID-19 took over North America.

Instead of its immediate planned expansion into the US with clinic locations in New York and Los Angeles, Field Trip has started investing in digital therapeutic technology tools to enhance patient access, which Levy said will be crucial for the larger patient experience.

relaxing room at Field Trip Health's clinic in Toronto

Patients are encouraged to debrief after going through a ketamine drug trip. Photo by Bryan Mc Govern.

When asked about the potential to go public and a likely timeline for this event, the Field Trip executive said the capital-intensive demands of the business will warrant additional funds.

“At the end of the day, we’re building a whole new industry here, it’s probably going to be quite capital intensive,” Levy said.

All the speculation was resolved on June 15, as the company confirmed its intention of going public by way of a proposed transaction. It initially had an agreement with Mira X (TSXV:MIRA.P), but it was quickly set aside in favor of a new deal to go public with Newton Energy (TSXV:NTN.H).

Besides the agreement to launch Field Trip on the public markets, the psychedelics firm announced a private placement that will secure it gross proceeds of C$14 million, indicating a price point of C$2 per share. The transaction is being co-run by boutique bankers Canaccord Genuity and Stifel.

Field Trip will soon join a growing list of companies pursuing ventures into the psychedelic drug industry while raising capital in the Canadian markets.

Investor takeaway

Clinics are set to play an important role in the development of psychedelics beyond the investment landscape. They will likely serve as the introduction or starting point for many patients gaining interest in the promise of these novel drugs.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

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Positive topline results validated by additional analyses - Patient improvements beyond reduction of depression symptoms - Further insights into timing and circumstance of adverse events demonstrate COMP360 psilocybin therapy was generally well-tolerated London, UK 1 December 2021 COMPASS Pathways plc a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, ...

- Positive topline results validated by additional analyses

- Patient improvements beyond reduction of depression symptoms

- Further insights into timing and circumstance of adverse events demonstrate COMP360 psilocybin therapy was generally well-tolerated

London, UK 1 December 2021 COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced further results from its groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD). Additional analyses of primary and secondary endpoints validated topline findings and provided more insights into safety data. Analyses of exploratory measures including anxiety, self-reported depression, positive and negative affect, and functioning, showed greater improvements for patients receiving a 25mg dose of COMP360 psilocybin compared with those receiving a 1mg dose after three weeks, both with psychological support. Further analysis is ongoing and full trial results will be submitted for publication in a peer-reviewed journal. The data will be reviewed with regulators early next year. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.

Professor Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: "Our additional analyses underline the robustness of our findings that a single high dose of COMP360 psilocybin, given in conjunction with psychological support, led to a rapid and sustained response for many patients. This phase IIb study was designed to determine the optimal COMP360 dose for our phase III programme, evaluating safety and efficacy at the primary endpoint at week 3. Additionally, we observed consistent improvement in measures of anxiety, positive and negative affect, quality of life, daily functioning, cognition, and self-reported depression. We believe this could make a tremendous difference to patients suffering with treatment-resistant depression, who have few options available to them. Remember, a quarter of the 25mg group maintained response, as measured by the MADRS, at 12 weeks after a single administration with no other antidepressant medication. This finding in itself is unprecedented."

COMPASS reported topline data from this trial last month, which investigated three doses of COMP360 psilocybin (1mg, 10mg, 25mg) in 233 patients with TRD. The results showed that a single 25mg dose of COMP360 demonstrated a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with a rapid and durable treatment response. The 25mg group vs the 1mg group showed a -6.6 difference on the MADRS* depression scale at week 3 (p

As well as looking at clinician-rated depression severity on the MADRS, the trial explored other aspects which are recognised as being important for patients with TRD - and essential to recovery - including positive and negative affect, anxiety, self-rated depression severity, quality of life, functioning and cognition. These exploratory measures also showed that patients in the 25mg dose group of COMP360 psilocybin therapy reported benefits on those measures over those in the 1mg group. On the PANAS* scale measuring positive and negative affect, patients in the 25mg group had a higher increase in positive affect (eg including feeling interested, excited, strong) and a greater decrease in negative affect (eg including feeling distressed, upset, afraid) on the day after COMP360 administration and at the questionnaire's final administration at week 3. On scales measuring anxiety (GAD-7*), self-rated depression (QIDS-SR-16*) and functioning (SDS* and WSAS*), a greater improvement was also shown at week 3, by patients in the 25mg group compared with the 1mg group.

A post-hoc analysis of the 19 sustained responders in the 25mg group found that changes in quality of life, self-reported depression severity, and functioning, were clinically meaningful, with mean scores for these patients returning to "normal" levels and maintained to 12 weeks, the end of the trial. Durability is being studied in a one-year follow-up study which is currently underway.

As noted in the topline data reported last month, COMP360 psilocybin was generally well-tolerated. Further analysis showed that there were no concerns with vital signs, ECG or clinical laboratory data in any of the treatment groups. The majority of treatment-emergent adverse events (TEAEs) occurring on the day of COMP360 administration resolved on the same day or the day after (77.4%); most of these events were mild or moderate in nature, eg headache, nausea, fatigue. All TEAEs involving hallucination (which only occurred in the 25mg and 10mg groups) and illusion (which occurred in all groups) started on the day of administration and resolved on the same day. No events of this nature continued past the administration day.

TEAEs of suicidal ideation, suicidal behaviour and intentional self-injury were seen in all groups, as is regularly observed in a TRD population. Two thirds of the patients had previous thoughts of wishing to be dead, as assessed by a suicidality scale completed during patient screening; this included all patients reporting one of these adverse events, so all patients who experienced these events during the trial had said in patient screening that they had had suicidal thoughts prior to the trial. Further detailed case-by-case analysis of safety data found no evidence to suggest, at this time, a causal relationship between these reported adverse events and administration of COMP360. The events occurred in all treatment groups and at a range of onset times and durations; the majority occurred more than a week after the psilocybin session.

  • There was no difference between the three groups post-administration in scores from item 10 on the MADRS, which measures suicidality and was assessed by a blinded remote rater; mean scores across treatment groups were lower than baseline at all subsequent time points
  • 27 of the TEAEs of suicidal ideation, suicidal behaviour and intentional self-injury occurred across 17 patients, with seven patients in the 25mg group, six in the 10mg group, and four in the 1mg group
  • 14 of these events were reported as treatment-emergent serious adverse events (TESAEs); these occurred across nine patients, with four patients in the 25mg group, four patients in the 10mg group, and one in the 1mg group
  • The majority of these TESAEs (10 events out of 14) occurred at least one week after the COMP360 psilocybin session
  • All suicidal behaviours occurred at least one month after the psilocybin therapy session and all patients reporting these events were non responders at their last assessment prior to the event or at the time of the event

Professor Goodwin said: "Further understanding of the timing and circumstance of adverse events in the trial demonstrates that COMP360 psilocybin therapy was generally well-tolerated. More detailed analysis of the safety data supports our conclusion that there is no evidence to date to suggest a causal relationship between the serious adverse events of suicidal ideation, suicidal behaviour and self-injury, and administration of COMP360 psilocybin therapy. Unfortunately, these events occur unpredictably and are to be expected in this patient population."

He continued: "We are now taking all the data we have generated and using it to inform our clinical development programme so we can understand which patients we might be able to help and how we might help more of them. We will be discussing this with regulators early next year as part of our ongoing dialogue with them."

Sidney Zisook MD, Director of the University of California San Diego Residency Training Program, a Distinguished Professor of Psychiatry at UCSD, and a Principal Investigator on the trial, said: "Many of the participants in this study had suffered for years with severe and crippling depressive disorders despite multiple treatment trials with traditional antidepressant medications and therapies. To see so many experience a robust and sometimes persisting response - and a new, brighter, more positive attitude - during the course of the study, was immensely gratifying and hopeful."

Further detail on additional findings from exploratory measures

  • Affect : results from the PANAS (Positive Affect and Negative Affect Schedule) showed higher positive affect and lower negative affect changes from baseline in the 25mg vs 1mg groups at day 2 and week 3. For positive affect and negative affect, there was a least squares mean (95% confidence intervals) treatment difference favouring the 25mg vs 1mg group at week 3: 6.17 (3.53, 8.82) and -3.18 (-5.59, -0.77), respectively
  • Anxiety: changes from baseline in the GAD-7 (Generalised Anxiety Disorder-7 item scale) total score were greater in the 25mg group vs the 1mg group at week 3. For GAD-7, a least squares mean (95% confidence intervals) treatment difference favouring the 25mg vs 1mg group was found at week 3:  -1.79 (-3.35, -0.23)
  • Self-reported depression: changes from baseline in the QIDS-SR-16 (Quick Inventory of Depressive Symptomatology - Self Rated - 16 item scale) total score were greater in the 25 mg group at weeks 1, 2 and 3, compared with the 1mg group. The least squares mean treatment difference (95% confidence intervals) at week 3 was -2.78 (-4.62, -0.95)
  • Functioning: changes from baseline in the SDS (Sheehan Disability Scale) and the WSAS (Work and Social Adjustment Scale) were greater in the 25mg group vs the 1mg group at week 3. There was a treatment difference of -6.49 (95% confidence interval = -9.52, -3.46) on the SDS 25mg vs 1mg at week 3 and a treatment difference of -5.11 (95% confidence interval = -8.39, -1.82) on the WSAS between the 25mg vs 1mg at week 3
  • Quality of life: no differences were seen between the groups on the EQ-5D-3L (EuroQol-5-Dimension-3-Level Scale) total score and EuroQoL-Visual Analogue Scale – all groups showed an improvement over time. On the EQ-5D-3L total score, the 25mg vs 1mg least squares mean treatment differences at week 3 was 0.06 (95% confidence intervals = -0.03, 0.15). On the EuroQoL Visual Analogue Scale, the 25mg vs 1mg treatment difference at week 3 was 6.77 (95% confidence interval = -0.37, 13.90). A post-hoc analysis of sustained responders in the 25mg group found that changes in quality of life were clinically meaningful, with mean scores in these patients returning to "normal" levels and maintained to 12 weeks
  • Cognition: no differences were seen between the groups on the DSST (Digit Symbol Substitution Test) – all groups showed an improvement over time. The least squares mean treatment difference between the 25mg vs 1mg groups at week 3 was 1.32 (95% confidence intervals = -1.00, 3.64)

-Ends-

Notes to editors:

About treatment-resistant depression (TRD)
More than 320 million people globally suffer with major depressive disorder (MDD) 1 , the leading cause of disability worldwide and one of the fastest growing mental health illnesses 2 . About a third of these patients - 100 million people - aren't helped by existing therapies and suffer with treatment-resistant depression (TRD) 3 . As many as 30% of these attempt suicide at least once during their lifetime 4 , 5 . TRD carries two to three times the medical costs of a non-TRD MDD patient, and patients with TRD have a higher all-cause mortality compared with non-TRD MDD patients 6 . The TRD population is by definition more difficult to treat and more likely to relapse than patients with major depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designati on for its COMP360 psilocybin therapy for TRD.

About the COMP360 psilocybin therapy phase IIb study
This randomised, controlled, multicentre, double-blind phase IIb trial is the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. 94% of the patients had no prior experience with psilocybin. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.

The trial assessed the safety and efficacy of COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total of 233 patients enrolled in the study and were randomised and blinded into three arms comprising 79 patients for each of the 25mg and 1mg doses, and 75 patients for the 10mg dose. Patients were followed up for 12 weeks. The trial used the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression; assessments were made by an independent, blinded rater. The primary endpoint was the change in the MADRS total score from baseline to week 3.

 About COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p www.compasspathways.com

Availability of other information about COMPASS Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS's expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS's business strategy and goals, the future accessibility of COMP360 psilocybin therapy, COMPASS's ability to continue to advance its research, including COMP360, COMPASS's expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS's ability to advance new psychedelic compounds in other areas of unmet mental health need. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading "Risk Factors" in COMPASS's annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS's current expectations and speak only as of the date hereof.

Enquiries
Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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