With a new name and fresh $100M, Lykos prepares for the first psychedelic approval

2024-01-05

临床3期优先审批上市批准突破性疗法申请上市

The first FDA approval of a psychedelic is within reach for MAPS Public Benefit Corporation, which rebranded as Lykos Therapeutics on Friday and announced it had raised $100 million. The company submitted an NDA in December for the use of MDMA in combination with psychological intervention, such as talk therapy, to treat post–traumatic stress disorder (PTSD).

The funding, which comprises an oversubscribed Series A round and the conversion of previously issued convertible notes, will go towards regulatory and pre-launch activities, Lykos CEO Amy Emerson told FirstWord.

The financing was led by Helena, with participation from other investors including the Steven & Alexandra Cohen Foundation, Eir Therapeutics, Vine Ventures, True Ventures, Unlikely Collaborators Foundation, The Joe and Sandy Samberg Foundation, Bail Capital, KittyHawk Ventures and Satori Neuro.

The path to approval

Lykos was formed in 2014, prompted by a “substantial need for new treatments for individuals with PTSD,” Emerson said.

Because MDMA, which is more commonly known as ecstasy, received Breakthrough Therapy designation in 2017, the company has asked the FDA to grant the NDA filing priority review.

The submission was based on the MAPP1 and MAPP2 Phase III trials of MDMA, which both met their primary and secondary endpoints.

In September, data from the MAPP2 trial was published in Nature. The study found that MDMA-assisted therapy significantly reduced PTSD symptoms versus placebo, confirming the findings of MAPP1. No serious adverse events were reported in either trial.

Emerson said that in the future, Lykos would like to research psychedelics in other indications.

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机构

Lykos SA