Mindstate Design Labs, a Y Combinator-backed startup, has achieved a significant milestone in its quest to revolutionize the field of psychedelics. The company has received approval from both the FDA and the European Medicines Agency (EMA) to initiate human trials for its groundbreaking compound, MSD-001.
MSD-001 is at the heart of Mindstate’s innovative approach to psychedelics. The company’s CEO, Dillan DiNardo, describes it as “somewhat tofu-like” or “psychedelic tofu,” due to its mild effects at clinical doses. While sharing common properties with traditional psychedelics such as MDMA, psilocybin, and LSD, MSD-001 boasts a key difference: a much narrower range of effects. This makes it an ideal foundation for creating precisely tailored altered states of consciousness.
DiNardo explains that the key to MSD-001’s unique properties lies in its “serotonergic specificity.” Unlike more complex psychedelics, MSD-001 primarily targets specific serotonin receptors in the brain, leading to its predictable and controlled effects. He further emphasizes that at clinical doses, the “entity interactions” seen with DMT or the “ego loss” associated with higher doses of psilocybin are unlikely to occur with MSD-001.
The true innovation lies in how MSD-001 interacts with other compounds, referred to as “probes.” These probes can be used to introduce specific, targeted psychoactive effects, ranging from mild to more pronounced, depending on the dosage and type of probe used. This modular approach allows Mindstate to create a wide array of customized states of consciousness, offering unprecedented control and precision in the field of psychedelics.
With FDA and EMA approval in hand, Mindstate will commence Phase 1 human trials for MSD-001 at the Centre for Human Drug Research in Leiden, Netherlands. The trials, involving 52 healthy participants, will be conducted as a double-blind, placebo-controlled study. The primary focus will be on safety, tolerability, and the drug’s pharmacokinetic (PK) and pharmacodynamic (PD) properties. Additional assessments utilizing qEEG and fMRI will be conducted to map the neural basis of psychedelic action.
DiNardo emphasizes the importance of these trials, not just for MSD-001 but for the future of psychedelic research as a whole. He envisions a future where tailored psychotropic therapies can address a wide range of conditions, potentially expanding beyond the traditional scope of psychedelics. The company’s research aims to move beyond simply studying existing psychedelics and their effects, to instead utilize these compounds as tools for understanding the intricate architecture of the human mind, enabling the deliberate design of specific states of consciousness.
Mindstate’s approach is deeply rooted in ethical considerations, with a meticulous focus on characterizing potential adverse events associated with existing psychedelics. The company’s designed states of consciousness prioritize safety, aiming to achieve a profile of psychoactive effects that maximize efficacy for patients. This focus on precision and control offers physicians and their patients greater predictability and manageability in the treatment process.
At the heart of Mindstate’s work is its AI-driven Osmanthus platform. This powerful tool integrates over 70,000 human drug reports with the world’s most extensive repository of biochemical data on psychedelics. This massive dataset allows Mindstate to design specific, targeted psychoactive effects with unprecedented precision. While the platform draws heavily from controlled settings, books, and reliable data, it also incorporates anonymous reports from the internet, relying on the volume of data to filter out unreliable information.
Mindstate’s unique approach, focusing on the deliberate design of specific states of consciousness rather than simply discovering new drugs, positions the company at the forefront of psychedelic research. DiNardo refers to this as a “mindstate-first approach,” highlighting the significant advantage it offers in precision and control. This approach allows the company to design specific acute psychoactive effects, overcoming the limitations imposed by the pre-determined effects of existing chemical structures.
The company’s ambition extends to the integration of these novel formulations into the market. DiNardo envisions MSD-001 as a potential first-line treatment for a range of mental health conditions, potentially used in combination with or independently of existing medications. The company aims to create disease-modifying therapies that provide real relief to patients, rather than simply managing symptoms, a common limitation of traditional medications.
