NEW YORK and BERLIN – atai Life Sciences (NASDAQ: ATAI), a biopharmaceutical company focused on mental health disorders, announced positive preliminary results from a Phase 1b trial of VLS-01, an oral transmucosal film formulation of N,N-dimethyltryptamine (DMT). The trial aimed to assess the safety, tolerability, and pharmacokinetics of VLS-01 compared to intravenous DMT.
The study involved 17 healthy participants who received a single dose of intravenous DMT followed by three different doses of VLS-01 buccal film with a 28-day washout period between administrations. The higher doses of VLS-01 showed comparable peak plasma concentrations to the 30mg IV DMT dose, achieved within 30-45 minutes.
The 120mg dose cohort had significant subjective effects that resolved within 120 minutes, with participants reporting psychologically meaningful experiences.
VLS-01 was well-tolerated, with most adverse events being mild or moderate and resolving on the day of dosing. The most common treatment-emergent adverse events included headache, dissociation, euphoric mood, and nausea, with no severe events related to blood pressure, heart rate, or suicidality.
Dr. Srinivas Rao, Co-CEO and Co-founder of atai, expressed optimism about VLS-01's potential as a treatment for the estimated 100 million people suffering from treatment-resistant depression (TRD). He highlighted the balance between psychedelic effect intensity and safety at the 120mg dose, which fits into the two-hour in-clinic treatment model for interventional psychiatry.
Following these results, atai plans to initiate a randomized, double-blind, placebo-controlled Phase 2 study around year-end 2024 to further assess the safety, efficacy, and response durability of repeated VLS-01 doses in patients with TRD.
The trial will involve two treatment periods, with the primary endpoint being the change in the Montgomery-Asberg Depression Rating Scale score at Week 4, and the last assessment at Week 14. The second treatment period will explore the response to two different dose levels of VLS-01, with final assessments two weeks post-administration.
VLS-01 aims to offer a convenient oral dosing alternative to intravenous administration, leveraging DMT's rapid-acting antidepressant effects.
This announcement is based on a press release statement from atai Life Sciences.
In other recent news, atai Life Sciences is making significant strides in its clinical trials and corporate restructuring. The biotechnology company's Phase 1 clinical study results for ELE-101, an intravenous form of psilocin, have been well-received, with TD Cowen maintaining its 'Buy' rating on the company's stock. The study results have guided the dosing for the subsequent Phase 2a segment, with topline data expected in the second half of 2024.
The company has also initiated a Phase 2a trial for ELE-101. Similarly, atai Life Sciences reported positive Phase 1 results for BPL-003, a novel intranasal formulation of 5-MeO-DMT, which is now being further investigated in Phase 2a studies for Alcohol Use Disorder and Treatment Resistant Depression.
On the corporate front, Jason Camm has amicably resigned from his role as a supervisory director at atai Life Sciences. The company welcomed Dr. Scott Braunstein and Dr. Laurent Fischer to its supervisory board, a move aimed at enhancing the company's journey into later-stage clinical trials.
These are the recent developments in the company's pursuit of mental health treatments.
InvestingPro Insights
As atai Life Sciences (NASDAQ: ATAI) advances its trials with VLS-01, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, atai Life Sciences holds a market capitalization of approximately $207.58 million, reflecting the scale of the company in the biopharmaceutical landscape. The company's price-to-book ratio over the last twelve months as of Q1 2024 stands at 0.93, indicating that the stock is trading at a value close to the company's net asset value. This metric can be particularly relevant for investors looking for potential value investment opportunities in the biotech sector.
InvestingPro Tips highlight that atai Life Sciences holds more cash than debt on its balance sheet, which can be a reassuring sign for investors concerned about the company's solvency and financial flexibility. However, it's important to note that analysts have concerns about the company's profitability, as they do not anticipate atai will be profitable this year and expect net income to drop. This is a crucial consideration for investors who are evaluating the company's potential for long-term growth and profitability.
On the performance front, the stock has experienced a significant decline over the last week and month, with a one-week price total return of -9.49% and a one-month price total return of -19.48%. This recent performance may influence investor sentiment and could be indicative of market reactions to the company's latest developments or broader sector trends.
For those seeking a more comprehensive analysis, InvestingPro offers additional tips on atai Life Sciences, providing deeper insights into the company's financials and stock performance. With more tips available, investors can make more informed decisions by accessing a broader range of expert analysis and data points.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.