Compass Pathways Plc

Company Leaders To Contribute to Key Discussions On The Future Of Mental Health Treatment, Unveiling Innovations In Genetic Companion Diagnostics And Psychedelic TherapiesMUNICH, Oct. 31, 2024 (GLOBE NEWSWIRE) -- HMNC Brain Health (or “HMNC”), a clinical-stage precision psychiatry biopharma company, pioneering the development of personalized therapies powered by predictive companion diagnostics, today announced its participation at CNS Summit, the leading life sciences gathering, taking place from November 10-13, 2024, in Boston, Massachusetts. This year’s event brings together the leading minds in the life sciences, and HMNC Brain Health will play a pivotal role in two key discussions shaping the future of precision psychiatry and psychedelics. Panel: Dr. Hans Eriksson, Chief Medical Officer at HMNC Brain Health, will join a panel to discuss the future of psychedelics in mental health care. The panel, “Psychedelic Forum Spotlight Session,” will be held on Tuesday, November 12, 2024, from 1:00 to 1:50 PM ET in session room Renoir 1/2. Alongside other industry leaders, Dr. Eriksson will delve into breakthrough innovations and the regulatory landscape that could transform the treatment for conditions such as depression and PTSD. Joining him on this panel are: Kabir Nath, Co-CEO, Compass Pathways (Chair)Srinivas Rao, Chief Scientific Officer, Atai Life SciencesDan Karlin, Chief Medical Officer, MindMed This panel will address pressing questions about commercial viability, safety profiles, and next steps for psychedelics in mainstream treatment options, giving investors and industry insiders a glimpse into what’s next for this evolving field. Poster Presentation: In a significant showcase of its precision psychiatry advancements, Dr. Daniel Gehrlach, Associate Director of Biomarkers at HMNC Brain Health, will present research that could redefine treatment pathways for mental health disorders. His poster, titled “Precision Psychiatry with Co-Development of Genetic Companion Diagnostics: A Novel Approach for Clinical Development,” will be presented on: Date: Monday, November 11, 2024Time: 5:00 to 7:00 PM ETPoster Number: 28 Dr. Gehrlach’s presentation will unveil HMNC’s innovative use of genetic companion diagnostics to guide psychiatric treatments for individual patients, a step that promises to significantly increase efficacy and reduce trial-and-error in mental health therapies. This poster will highlight HMNC’s methods in developing personalized treatments for Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). Together, these presentations underscore HMNC Brain Health’s leadership at the intersection of neuroscience, precision medicine, and next-generation psychiatric treatments. To schedule a one-on-one meeting with HMNC’s management team during the CNS Summit, please contact HMNCBrain@kcsa.com. About HMNC Brain HealthHMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company headquartered in Munich, Germany, pioneering the development of personalized therapies powered by predictive companion diagnostics, leading to higher remission rates. The company develops a unique pipeline targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). With a presence in both Germany and the U.S., HMNC is backed by renowned global venture capital firms, family offices, and strategic healthcare investors. For more information, visit www.hmnc-brainhealth.com. About CNS SummitCNS Summit is a multi-therapeutic, executive community of life sciences innovators and industry leaders devoted to discovering better, more efficient ways to develop new treatments for patients. Developed by the life sciences industry, for the life sciences industry, CNS Summit is a year-round, worldwide community that convenes each November in Boston for four days. Media Contact (U.S.): Anne Donohoe(732) 620-0033hmncbrain@kcsa.com

Compass Pathways is pushing back the timelines of two key pivotal readouts, delaying data for a psilocybin program that’s one of the leaders in psychedelic drug development. The first Phase 3 pivotal study, COMP005, is now expected to read out in the second quarter of 2025, the company said Thursday in its third-quarter earnings release . Compass originally planned to report the data in the fourth quarter of this year. A second Phase 3 study testing two fixed doses of psilocybin is now expected to read out in the second half of 2026, about a year longer than originally expected. Its stock $CMPS fell about 15% in premarket trading on Thursday. The reasons for the new delays are different, CEO Kabir Nath told Endpoints News. He didn’t sugarcoat the COMP005 decision, saying there’s been a delay accruing data in the trial. “When we started to project Phase 3 timings, we took the Phase 2b speed of enrollment [and] adjusted it down because we recognized it was more complicated,” Nath said. “We didn’t adjust it down enough.” He attributed the delay to “logistical complexity” like having to arrange for therapists to participate in sessions with patients or scheduling patients for multiple dosing sessions. Compass R&D chief Mike Gold has been to several sites in the COMP005 trial, Nath said, working on the ground to troubleshoot when there are snags in trial progression. “We just underestimated, just the complexity and the time it would take to get it done,” Nath said. “There’s no sugaring that pill.” The rationale behind postponing the two-dose study, COMP006, is a concession to regulators. Nath said that the decision was to protect the blinding of all the trial’s participants, an element that Compass is particularly cautious about after hearing feedback given to Lykos Therapeutics earlier in the year. In trials involving psychedelics, it’s often easier for participants to guess whether they’ve received treatment, known as functional unblinding. In Lykos’ Phase 3 trials, most participants were able to correctly guess whether they received MDMA. “We actually have to preserve that blinding through the full part B so that’s the rationale,” Nath said. In order to preserve cash, Compass is laying off 30% of its employees, including senior management and members of the preclinical team. The company had 186 employees, as of Dec. 31. A spokesperson said that chief communications officer Christopher Williams and chief legal officer and general counsel Matthew Owens — both longtime pharma execs — are departing. The preclinical work, largely unknown, included a team developing “a pretty interesting library of compounds that we’re now going to put on the shelf,” Nath said. CFO Teri Loxam underscored the decision was meant to preserve, not extend, cash. Because the COMP005 readout was delayed, the company needed to downsize to confidently fund operations through that milestone, which could be a catalyst to either raise more money or help draw a commercial partner. Compass still has $207 million, enough to last into 2026. Both Nath and Loxam said that the logistical challenges seen in the trials, namely COMP005, should not translate to commercial uptake. Specifically, they don’t anticipate needing therapists to monitor patients if approved and are advocating to healthcare professionals that licensed psychiatric nurses or nurse practitioners could administer psilocybin. The company’s reasoning is that healthcare professionals are providing “psychological support,” not therapy, another difference compared to Lykos, which described its program as “MDMA-assisted therapy.”

Dive Brief:Compass Pathways said it will lay off 30% of its workforce, narrow its research focus and explore selling its digital technologies after pushing back the timeline for its lead medicine, a psychedelic treatment for depression.The company now plans to release topline data from a Phase 3 study known as COMP005 in the second quarter of next year after telling investors in August to expect the data in the fourth quarter of this year. Results from a second study, COMP006, will likely be announced in the second half of 2026; Compass previously targeted mid-2025 for top-line data from that study.All resources at the company will be focused on advancing the lead drug, a synthetic form of psilocybin, for treatment-resistant depression, CEO Kabir Nath said. The program, dubbed COMP360, is our absolute priority, Nath said in the companys statement Thursday.Dive Insight:The delayed Phase 3 timeline follows the Food and Drug Administrations decision in August to reject Lykos Therapeutics bid to market MDMA-assisted therapy for post-traumatic stress disorder. FDA advisers had previously questioned the trial data for the drug, focusing especially on the question of functional unblinding.Typically, a clinical trial will split patients into groups, with some receiving the experimental medicine and others getting a placebo. In most cases, both the patients and researchers are blinded as to which drug is being administered, which in theory prevents any bias or placebo effect from interfering with the results.But in the case of psychedelics, the associated changes to cognition and senses may clue patients in the treatment group in to the fact that they are receiving the experimental drug. That, in turn, results in functional unblinding that may affect the results.For Lykos, the FDA rejection led to a 75% cut in staff and the departure of the companys founder. But the agencys decision may have a broader effect as well, putting a chill on what has been growing interest in developing psychedelics for mental health disorders.Compass said it now plans to wait to release data from COMP006 until after the blinded portion of its study has been completed by all patients and the 26-week time point has passed due to the increased regulatory scrutiny on functional unblinding. It did not give details on the delay for COMP005 in its statement.With a potential approval and revenue stream now further off,Compass said its slimming down staff, general and administrative functions and eliminating two senior management roles, for the chief communications officer and Matthew Owens, who serves as chief legal officer and general counsel. All preclinical work that doesnt affect the COMP360 program will also be stopped. '