Lykos CEO Steps Down In Management Shakeup
Lykos Therapeutics announced changes to its senior management team on September 5, continuing the restructuring that began last month after the FDA’s rejection of the company’s New Drug Application for MDMA-Assisted Therapy for PTSD. Amy Emerson, who led the company since its initial establishment as MAPS Public Benefit Corporation in 2014, will be stepping down as CEO. Michael Mullette, who joined Lykos as chief operating officer in 2022, will serve as interim CEO. Additionally, Dr. David Hough has been promoted from an advisory role to chief medical officer.
Last month, Lykos laid off 75% of its workforce and shifted its priorities to clinical development and regulatory engagement with the FDA. Elevating Mullette and Hough further illustrates Lykos’ strategic pivot towards engaging new leadership with experience navigating the complex regulatory landscape required for drug approval and commercialization. Emerson’s departure, which follows MAPS founder and president Rick Doblin leaving Lykos’ board of directors last month, also shows Lykos separating from its roots as a spin-off of MAPS, and focusing on the medicalization of MDMA as its primary goal.
Big Pharma, Small Company
Lykos is now primarily run by a collection of experienced managers from the pharmaceutical industry. Mullette has held international management and leadership roles in the pharma industry for more than twenty years. Prior to joining Lykos he oversaw the commercialization of Moderna’s COVID-19 vaccine in North America. In a LinkedIn post from 2022, Mullette said his Moderna experience taught him “how to build teams and capabilities from scratch, how to set up a never-commercial business for success, and how to manage tremendous uncertainty in a business that was center stage.”
Mullette joined Lykos to support its anticipated commercial launch of MDMA-assisted therapy for PTSD, and now is tasked with pivoting the company back into a start-up posture while salvaging the organization’s efforts to get the drug approved.
“Mike is a highly experienced leader with the right background and skills to steer Lykos as we engage with the FDA and work to bring this pioneering treatment to patients in need,” said Jeff George, chairman of the Lykos board of directors, in a press release. “Mike has been highly impactful in his role as COO and has a deep understanding of the path ahead.”
Hough was vice-president of research and development at J&J Innovative Medicine, where he led the Spravato, esketamine nasal spray program, overseeing medical, scientific, manufacturing, and commercial elements. Before his pharmaceutical career, Hough served as an officer and psychiatrist in the U.S. Army, managing behavioral health departments and training psychiatry residents. His military background aligns with the advocacy of veterans’ organizations and congressional allies who have been strong supporters of MDMA-assisted therapy for PTSD.
“Charting a path toward FDA approval will require seasoned leadership and expertise,” said Suprotik (Protik) Basu, Lykos board director and managing partner at Helena, Lykos’ lead investor. “I have deep conviction in their ability and commitment to bringing this treatment, if approved, to the millions who are waiting with great hope.”
So Long, Psychedelia
Emerson will assume an observer role on Lykos’ board of directors and remain as a senior advisor to the company through the end of this year. Her work on the medicalization of MDMA-assisted therapy began in 2003 when she joined the MAPS nonprofit as a pro bono consultant, and went on to establish the MDMA clinical development program. Emerson was appointed CEO of MAPS PBC in 2014 when the for-profit public benefit company was established as a wholly-owned subsidiary of the nonprofit organization.
“Amy’s contributions to Lykos, and to innovation in the field of mental healthcare more broadly, cannot be overstated,” said George. “She has helped pioneer the pathway for this FDA-designated breakthrough therapy program since its infancy. We are deeply grateful for her leadership and service.”
“We founded Lykos with a deep belief in the need for innovation in mental health, and I am deeply grateful for the privilege of leading our efforts,” Emerson said. “While we are not at the finish line, the past decade of progress has been monumental.”
For many years, the MAPS nonprofit raised tax-exempt donations for research into MDMA-AT and other psychedelic therapies. Last January, MAPS sold its majority interest in Lykos to investors and the company became an independent public benefit corporation. The nonprofit retains a minority stake in the drug company as its largest single shareholder, which affords it six seats on its board of directors.
Following his departure from the Lykos board, Doblin announced plans to develop “public benefit metrics to hold psychedelic companies like Lykos accountable for their public benefit mission.” As Lykos evolves its corporate culture, questions are emerging about the relationship between the two organizations, and the role of MAPS in guiding the pharma company’s approach to public benefit.
Lykos Refocuses and Evaluates The Role of Therapy
While Lykos slims down its operations, the company is also reevaluating the path forward for the resubmission of its New Drug Application for MDMA-AT, a mission that Hough will oversee. Lykos is requesting a meeting with the FDA to discuss the Complete Response Letter (CRL) issued by the agency last month, which the company has not shared publicly.
On September 4, Hough told Psychedelic Alpha that he believes Lykos has demonstrated sufficient “efficacy, safety or benefit risk” in some areas highlighted in the CRL and that it “would be a point of discussion” with the FDA about whether a new Phase 3 clinical trial would be needed, and if so, what size and design would it take.
Hough said that re-evaluating the role of therapy “is a topic of conversation” in Lykos’ resubmission strategy. “I want this drug, when it gets finally approved, to be used in a variety of contexts,” Hough said. “I don’t want to sort of pre-specify that ‘it has to be this way’ or ‘it can’t be any other way’.” Hough anticipates MDMA being used in a variety of contexts once approved, and seeks “broad generalizability so that it could be used with other evidence-based therapies as well.”
Hough said Lykos will “have an Advisory Board of experts in PTSD to look at all the evidence-based therapies” to guide its resubmission approach. Hough said this may include the “inner-directed approach” that was used in the MAPP1 and 2 clinical trials.
Hough believes “the FDA will be thoughtful and data-driven in their final decisions because that’s been my experience with them through the Spravato program.” He told Psychedelic Alpha, “I think they will partner with us – I’m optimistic.”
For now, Hough says, “I’m going to be focusing on my responsibilities here and making sure that we have a successful meeting with FDA, that we have a path forward, and that the whole research and development organization starts moving as one towards getting the approval.”