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Promising results from a clinical trial of the LSD-like substance MM120 have persuaded the Food and Drug Administration (FDA) to award it “breakthrough therapy” status as a treatment for generalized anxiety disorder (GAD).
The drugmaker behind MM120—Mind Medicine Inc., or MindMed—said in a press release Thursday that it plans to hold an end-of-Phase 2 meeting with FDA in the first half of 2024 and begin a Phase 3 clinical trial in the second half of the year.
Results of the latest round of study showed that a single oral dose of MM120 (lysergide d-tartrate) led to “clinically and statistically significant” reductions in anxiety scores 12 weeks after administration, with 65 percent of participants showing a clinical response and 48 percent in clinical remission following the treatment.
Breakthrough drug status is meant to recognize the therapeutic promise of an emerging substance or therapy as well as speed the research and development of treatments that fill an unmet need. MDMA and psilocybin have also previously been awarded the designation.
“That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” David Feifel, professor emeritus of psychiatry at the University of California San Diego and an investigator in the latest MindMed study. “These results suggest the potential MM120 has in the treatment of anxiety, and those of us who struggle every day to alleviate anxiety in our patients look forward to seeing results from future Phase 3 trials.”
Unlike leading psychedelic-assisted therapies, such as the use of MDMA to treat PTSD, trials into the efficacy of MM120 did not include a talk therapy or psychotherapy component. “MM120 was administered as a single dose in a monitored clinical setting with no therapeutic intervention,” MindMed said.
“The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” MindMed’s director and CEO, Robert Barrow, said in a statement. “We are committed to bringing MM120 to people living with GAD and delivering on the potential of our pipeline to treat serious brain health disorders.”
Today, we announced the FDA has granted breakthrough therapy designation for MM120 in GAD. We also announced positive 12-week durability data from our Phase 2b study of MM120 in GAD and are hosting a call at 8AM ET to discuss details. Read more: https://t.co/1g7gYkE3by $MNMD pic.twitter.com/Y4w4gEG0NE
— MindMed (@mindmedco) March 7, 2024
According to a media representative for MindMed, MM120 is “a tartrate salt form of lysergide, a synthetic drug commonly known as LSD.”
“LSD is difficult to manufacture with high purity and tends to degrade quickly in the presence of light and water,” the company’s chief medical officer told CNN. “We’re manufacturing it to pharmaceutical industry standards, a highly pure version that is also shelf stable. So that’s a critical difference.”
Before taking the psychedelic, participants in the study were “clinically tapered and then washed out from any anxiolytic or antidepressant treatments and did not receive any form of study-related psychotherapy for the duration in their participation in the study.”
Reid Robison, a psychiatrist and chief clinical officer for the Utah-based psychedelics company Numinus who also was in investigator on the study, said the “positive results give me hope that this may translate into meaningful benefits for my patients.”
“As a clinician and clinical researcher,” Robinson said in a statement, “I applaud the way this study was designed by MindMed to isolate the effect of MM120 by removing confounding variables like additional medications and psychotherapy.”
MindMed said in its release that the most common adverse events for participants in the study were “illusion, hallucinations, euphoric mood, anxiety, abnormal thinking, headache, paresthesia, dizziness, tremor, nausea, vomiting, feeling abnormal, mydriasis and hyperhidrosis.”
A further presentation on the trial’s findings is set to be delivered during the American Psychiatric Association’s general meeting, scheduled to be held in New York on May 4–8.
The development is the latest in a series of developments around psychedelic-based therapies so far this year. Last month, FDA granted priority status to its review of MDMA-assisted therapy as a potential treatment option for post-traumatic stress disorder (PTSD). The agency has set a target date to make a determination by August 11, according to applicant Lykos Therapeutics (formerly named MAPS Public Benefit Corporation).
If the new drug application is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with talk therapy and other supportive services.
Last year, FDA released first-of-its-kind draft guidance on the “unique” considerations that researchers should take into account when studying psychedelics, which the agency says show “initial promise” as potential therapies.
Shortly after the MDMA capsule NDA was submitted to FDA, new standards from the American Medical Association (AMA) took effect in January that assign psychedelics-specific codes to collect data on the novel therapies.
Meanwhile, a separate study by researchers at New York University’s Langone Center for Psychedelic Medicine and the Centre for Psychedelic Research at Imperial College London recently found that pairing MDMA with either psilocybin or LSD helped people overcome the “challenging experiences” associated with use of psilocybin or LSD alone.
In 2022, the Biden administration said it was “actively exploring” the possibility of creating a federal task force to investigate the therapeutic potential of psilocybin, MDMA and others ahead of the anticipated approval of the substances for prescription use.
In California, meanwhile, Gov. Gavin Newsom (D) signed a bill last October that would allow doctors to immediately start prescribing certain currently illicit drugs like psilocybin and MDMA if they’re federally rescheduled.
Last February, Australia legalized MDMA and psilocybin for use by prescription.
LSD and similar substances, by comparison, have received comparatively less attention in recent years than psilocybin and MDMA. A study last year, however, found that both LSD and psilocybin could potentially be used as powerful treatments for pain without the dwindling efficacy over time associated with opioid-based treatment.
This story has been updated to reflect that MM120 is a tartrate salt form of LSD.
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