PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.
Emerge’s Hot Take
MAPS Public Benefit Corporation (MAPS PBC) is now Lykos Therapeutics. The company, a for-profit affiliate of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), made headlines in December when it submitted a New Drug Application for FDA approval of MDMA assisted therapy in the treatment of PTSD. This submission marked the first ever application to the FDA for a psychedelic-assisted therapy. MAPS PBC’s re-brand to Lykos is in part a preparatory step for the company to adopt its role as purveyor of the drug should the application be approved, and many speculate that the name “Lykos” was chosen in honor of MAPS’ founder Rick Doblin and his wolf Phaedrus. According to a statement released on Friday (Jan. 10), along with the name change comes a significant Series A funding round totaling $100 million. Key contributors are the non-profit organization Helena and previous MAPS funder the Steven & Alexander Cohen Foundation. This round represents an exceptionally strong influx of funding into the psychedelic space and will be utilized to support Lykos’ “regulatory and pre-launch activities.” The re-brand also includes a new Board made up of six MAPS appointees including Lykos CEO Amy Emerson and Helena Managing Director Protik Basu. Emerge attorney Sean Clancy had this to say: “It makes sense to mark the distinction between MAPS (a 501(c)(3) nonprofit) and Lykos (a for-profit public benefit corporation) with a rebrand, to prevent people from confusing the two organizations’ missions and operations. MAPS’ work over the past 37 years, advancing psychedelic policy, has been revolutionary. And revolution means change. Everyone in the space will be eagerly watching where MAPS goes next and how Lykos carries this new mantle.”
Other Noteworthy News
Potent Psychedelic Drug Banishes PTSD, Small Study Finds
NATURE – “[A] small trial in military veterans suggests that a lesser-known, potent psychedelic drug called ibogaine could be used to treat traumatic brain injury (TBI). One month after ibogaine treatment, the veterans reported that TBI symptoms such as post-traumatic stress disorder (PTSD) and depression had decreased by more than 80%, on average. ‘The drug seems to have a broad, dramatic and consistent effect,’ says Nolan Williams, a neuroscientist at Stanford University in California and a co-author of the study. The results of the trial, which did not include a control group, [were published Monday, Jan. 8] in Nature Medicine. The researchers found that one month after treatment, participants had average reductions of 88% in PTSD symptoms, 87% in depression symptoms and 81% in anxiety symptoms. On average, participants had mild-to-moderate disability before treatment and no disability one month after treatment, as assessed by a survey about their cognition, mobility, and other functions. The study is a ‘proof of concept’ that proper screening and administration can lower the risk of harmful side effects, [Maria] Steenkamp says. [Steenkamp is a clinical psychologist studying PTSD in veterans at the NYU Grossman School of Medicine.] Williams and his colleagues are now looking to study whether the drug can confer a long-term benefit and are using neuroimaging and biomarkers to assess how the drug works.”
AMA CPT III Codes for Psychedelic-Assisted Therapies Take Effect
THE DALES REPORT – “The American Medical Association‘s (AMA) Current Procedural Terminology (CPT) III codes for psychedelic-assisted therapies, as initially unveiled in July 2023, have officially been activated and went into effect January 1, 2024. These new codes represent a significant development, affording physicians and qualified healthcare providers a mechanism to pursue coverage and reimbursement for administering psychedelic-assisted therapy—pending approval by the U.S. Food and Drug Administration (FDA). The AMA had previously granted approval to a novel code designed to enhance accessibility to psychedelic therapy in the United States in May. Upon implementation, the code will serve as a tool to monitor and document the administration of psychedelic treatments. The code will also account for diverse staffing configurations, specifying the numbers and credentials of qualified healthcare professionals involved. Additionally, a sub-code catering to the participation of non-qualified health professional clinical staff will be made available. The temporary nature of these codes allows for data collection to substantiate usage, potentially leading to their conversion into permanent CPT I codes with assigned valuations for broad coverage and reimbursement.”
Colorado Voters Approved Psilocybin Mushrooms in 2022 – Now the State is Setting Up How They’ll Be Regulated
COLORADO PUBLIC RADIO – “Colorado is now one of the first states to have its own Division of Natural Medicine that will, in about a year, issue licenses to spaces where psilocybin will be legally consumed. A small team, which is about to grow, has been tasked with figuring out the specifics of launching the division. There’s been a call-out for a new hire for a few months. Once the position is filled, the division will gain some independence from its big sister in cannabis enforcement, with its own dedicated staffer. Shannon Gray, communications supervisor for the division sent an email with a link to the job description: ‘This position will serve as a senior authority over the statewide implementation of SB23-290 related to licensing and regulating the cultivation, manufacture, dispensation, transportation, and testing of natural medicines, including licensing individuals working in these businesses and licensing healing centers.’ [T]he division will oversee licensing at healing centers, where natural medicine could be administered to individuals 21 and older. The division will also keep an eye on the licensing and regulation of the cultivation and manufacture of medicines and testing facilities. Its other tasks include data collection, promotion, and training.”
LISTEN – 2023: The Year Legal Psychedelic Therapy Began in Oregon
JEFFERSON PUBLIC RADIO – “[In this podcast the Jefferson Exchange Team] looks back at the year’s events with [Healing Advocacy Fund (HAF)] Executive Director Sam Chapman and HAF Oregon State Director Heidi Pendergast.”
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