Lykos Therapeutics, formerly known as the MAPS Public Benefit Corporation (MAPS PBC), is a public benefit corporation (PBC) that is developing MDMA ("ecstasy") as a potential medicine.[1] It was founded and is considerably owned by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS).[1] MAPS PBC was founded in 2014 and was renamed to Lykos Therapeutics in January 2024.[1][2]
| Company type | Public benefit corporation |
|---|---|
| Industry | Pharmaceutical; Psychedelic medicine |
| Founded | 2014 |
| Website | lykospbc |
MDMA-assisted psychotherapy development program
editMAPS raised $140 million to fund its MDMA for PTSD development programme.[1] However, fundraising ultimately fell short, and this necessitated MAPS to change its strategy.[1] With MAPS PBC, following its rebranding to Lykos Therapeutics, MAPS raised a further $100 million.[1][3] Rick Doblin, the founder and former chief executive of MAPS, has said that he wished that MDMA for PTSD could have been developed purely with philanthropic funding, but that this goal had failed.[1] MAPS had also originally opted to follow an "anti-patent" strategy and not patent MDMA.[4] In December 2022 however, MAPS PBC filed patents for MDMA at specific particle sizes, and these patents were published in June 2024.[5][4] In January 2025, the patents were rejected by the USPTO and patent protection was not granted.[4]
In December 2023, MAPS PBC completed phase 3 clinical trials of MDMA-assisted psychotherapy for treatment of post-traumatic stress disorder (PTSD) and filed a New Drug Application (NDA) of MDMA for this indication with the United States Food and Drug Administration (FDA).[1] MDMA-assisted psychotherapy showed substantial effectiveness over placebo for treatment of PTSD in the two phase 3 studies.[6][7] This included PTSD remission rates of 67 to 71% with MDMA-assisted psychotherapy versus 32 to 48% with placebo-assisted therapy.[7]
MDMA approval rejection and subsequent developments
editIn June 2024, an 11-member FDA advisory panel of independent experts voted overwhelmingly against MDMA-assisted psychotherapy for PTSD.[8][6][9] Based on the data submitted, they voted 9-2 against it being effective and 10-1 against its benefits outweighing its risks.[8][6] The reasons cited for the rejection included concerns about functional unblinding, the side effects of MDMA such as cardiovascular effects, lack of detailed data collection on the misuse potential-related effects of MDMA in the trials, and accusations of professional bias, among others.[8][6][9][10] Historically, the FDA has followed the recommendations of its advisory panels.[3] Although the FDA had previously signed off on the phase 3 trial design in 2017, including notably the handling of placebo controls and agreeing to an inacive placebo control group,[10][6][9][11] the FDA ultimately decided to follow its advisory panel's recommendations and reject Lykos Therapeutics's NDA for MDMA-assisted psychotherapy for PTSD in August 2024.[3] They requested further data on the effectiveness and safety of MDMA-assisted psychotherapy for PTSD, including requiring a third phase 3 trial.[3][9] According to Doblin and Lykos Therapeutics, this would take two years or more to complete.[3][9][12] They and other critics maintained that many of the FDA's requests could be addressed with existing data, post-approval studies and requirements, and referencing of the existing scientific literature.[3]
In August 2024, days following the FDA's rejection of MDMA-assisted psychotherapy for PTSD, three papers on MDMA-assisted psychotherapy for PTSD by MAPS and Lykos Therapeutics researchers were retracted from the journal Psychopharmacology, with the reason cited being ethical violations.[11][9] This was most notably related to an inappropriate sexual relationship and alleged sexual assault of a trial participant by an unlicensed therapist that had occurred at one of the phase 2 clinical sites in Canada of MDMA-assisted psychotherapy.[11][9] MAPS and Lykos Therapeutics didn't directly disclose the ethical violations to the journal and didn't remove the data from that site from their analyses.[11][9] However, they had publicly disclosed the violations and to government agencies years before in 2019.[11][9] In addition, MAPS had cut ties with the therapist and instituted a new ethics code explicitly forbidding sexual contact between patients and therapists.[9] Psychopharmacology initially requested that MAPS PBC issue a correction by removing the relevant data from the analyses, which the company reportedly had complied with.[11]
On August 2024, also following the FDA's rejection, Lykos Therapeutics announced that it would lay off 75% of its workforce, which was about 100 employees, and that Doblin would resign from its board but remain with MAPS.[13][14][10] The Chief Executive Officer (CEO) of Lykos Therapeutics was formerly Amy Emerson.[1] In September 2024, she stepped down and was succeeded by Michael Mullette.[15] In January 2025, five more Lykos Therapeutics board members left the company and were replaced by new directors.[16]
In October 2024 and January 2025, despite setbacks, it was reported that Lykos Therapeutics had had productive new meetings with the FDA and was continuing to pursue approval of MDMA-assisted psychotherapy for PTSD.[17][18] Doblin himself considers eventual FDA approval likely, but believes that it may take a few more years.[10] In January 2025, it was reported that Antonio Gracias, a billionaire investor, former Tesla board director, and Elon Musk ally, was attempting to take control of Lykos Therapeutics with $100 million in new investment and proposals to restrengthen its ties with MAPS towards the goal of attaining FDA approval of MDMA-assisted psychotherapy.[19][20][21] Doblin has backed the plan.[19][20][21]
Market competition
editOther companies are also developing MDMA-assisted psychotherapy for treatment of PTSD and other psychiatric disorders.[12][22] However, none are close to approval as of late 2024.[12] Other companies, such as MindMed and Tactogen, are also developing other entactogens besides MDMA or racemic MDMA for treatment of psychiatric disorders as well.[23][24][25]
See also
editReferences
edit- ^ a b c d e f g h i Harrison, Annie Oak (12 January 2024). "How MAPS PBC Became Lykos Therapeutics and Raised $100M". Lucid News - Psychedelics, Consciousness Technology, and the Future of Wellness. Retrieved 3 February 2025.
- ^ Bayer, Max (5 January 2024). "Psychedelic biotech MAPS PBC rebrands to Lykos following FDA filing, scores $100M financing". Fierce Biotech. Retrieved 3 February 2025.
- ^ a b c d e f Stone, Will (9 August 2024). "FDA gives thumbs down to MDMA for now, demanding further research". NPR. Retrieved 3 February 2025.
- ^ a b c Psychedelic Alpha (16 January 2025). "Patent Analysis: Lykos Suffers Blow from USPTO As All Patent Claims Stand Finally Rejected". Psychedelic Alpha. Retrieved 3 February 2025.
- ^ Psychedelic Alpha (13 June 2024). "Breaking: Lykos Therapeutics Moved to Patent MDMA In Late 2022, Filing Reveals". Psychedelic Alpha. Retrieved 3 February 2025.
- ^ a b c d e Jarow, Oshan (4 June 2024). "MDMA's federal approval drama, briefly explained". Vox. Retrieved 3 February 2025.
- ^ a b Wolfgang AS, Fonzo GA, Gray JC, Krystal JH, Grzenda A, Widge AS, Kraguljac NV, McDonald WM, Rodriguez CI, Nemeroff CB (January 2025). "MDMA and MDMA-Assisted Therapy". Am J Psychiatry. 182 (1): 79–103. doi:10.1176/appi.ajp.20230681. PMID 39741438.
- ^ a b c Jacobs, Andrew (4 June 2024). "FDA Panel Rejects Use of MDMA for Treatment of PTSD". The New York Times. Retrieved 3 February 2025.
- ^ a b c d e f g h i j Jarow, Oshan (9 August 2024). "MDMA therapy didn't get FDA approval. Now what?". Vox. Retrieved 3 February 2025.
- ^ a b c d Briggs, Saga (23 December 2024). "Inside the battle for FDA approval of MDMA therapy". Big Think. Retrieved 3 February 2025.
- ^ a b c d e f Keshavan, Meghana (11 August 2024). "Three MDMA therapy papers retracted over ethics violations". STAT. Archived from the original on 11 August 2024. Retrieved 3 February 2025.
- ^ a b c Ault, Alicia (2 September 2024). "FDA Rejects MDMA-AT for PTSD, but Lykos Vows to Push On". Medscape. Archived from the original on 3 February 2025. Retrieved 3 February 2025.
- ^ Santhosh, Christy (16 August 2024). "Lykos to lay off 100 employees after MDMA drug setback; founder to exit board". Reuters. Retrieved 3 February 2025.
- ^ Taylor, Phil (16 August 2024). "Lykos co-founder Doblin to step down after MDMA setback". pharmaphorum. Retrieved 3 February 2025.
- ^ Masson, Gabrielle (5 September 2024). "Lykos CEO steps down, the latest move in a string of chaotic changes". Fierce Biotech. Retrieved 3 February 2025.
- ^ Manalac, Tristan (15 January 2025). "Lykos Loses Five Board Directors After FDA Rejection". BioSpace. Retrieved 3 February 2025.
- ^ McKenzie, Heather (21 October 2024). "Lykos Announces 'Productive' Meeting With FDA Regarding Rejected MDMA Drug". BioSpace. Retrieved 3 February 2025.
- ^ Waldron, James (17 January 2025). "Lykos still plotting path to approval for rejected MDMA therapy after 'productive' FDA meeting". Fierce Biotech. Retrieved 3 February 2025.
- ^ a b Barnes, Oliver (9 January 2025). "Elon Musk ally leads attempt to seize control of psychedelic biotech Lykos". Financial Times. Retrieved 3 February 2025.
- ^ a b Psychedelic Alpha (10 January 2025). "Billionaire Investor Antonio Gracias Plots $100M Lykos Takeover with Doblin's Backing". Psychedelic Alpha. Retrieved 3 February 2025.
- ^ a b Block, Jonathan (10 January 2025). "Psychedelic drug developer Lykos could get lifeline from former Tesla board member". Seeking Alpha. Retrieved 3 February 2025.
- ^ Jenkins, John A. (5 November 2024). "The Agony Around Ecstasy". Law Street Media. Retrieved 3 February 2025.
- ^ Ducharme, Jamie (2 October 2024). "Safer Psychedelic Drugs May Be Coming". TIME. Retrieved 3 February 2025.
- ^ Elder, Harrison (26 July 2022). "Ecstasy for the 21st Century: Designer Drugs to Improve MDMA Therapy". Psychedelic Science Review. Retrieved 29 January 2025.
- ^ Dunne, Rowan (27 September 2023). "California startup Tactogen gets U.S. patent for MDMA derivatives". Mugglehead Investment Magazine. Retrieved 29 January 2025.