COMPASS Pathways (CMPS) has announced a delay in the anticipated release of pivotal trial data for its COMP360 product, a potential treatment for treatment-resistant depression (TRD). The announcement was made during the Third Quarter 2024 Investor Call, citing recruitment challenges as the primary reason for the adjusted timelines. The company now expects to disclose data from the COMP005 trial in the second quarter of 2025 and from the COMP006 trial in the second half of 2026.
To preserve cash and focus on the successful completion of the Phase III COMP360 trials, COMPASS Pathways is implementing financial and operational adjustments, including a workforce reduction of approximately 30% and the cessation of non-COMP360 preclinical efforts.
Clinical Trial Updates and Data Disclosure
The delay in data disclosure is attributed to the complexity of the Phase III trials and recruitment challenges. According to Kabir Nath, CEO of COMPASS Pathways, the Phase IIb trial was a simpler protocol compared to the Phase III trials, which involve a 52-week trial design, blinded for the first 26 weeks, and multiple parts where additional doses can be administered. These complexities have made it challenging for sites to schedule patients and therapists, impacting the overall recruitment timeline.
For the COMP005 trial, COMPASS Pathways plans to disclose three key efficacy measures at the 6-week endpoint: the MADRS effect difference between the arms, p-value, and confidence intervals. The company will also provide a high-level assessment from the independent Data Safety Monitoring Board (DSMB) regarding safety risks and any imbalances in suicidal ideation. However, secondary endpoints and in-depth safety tables will not be disclosed at this time to maintain blinding.
The COMP006 trial, which has three active dose arms (1 milligram, 10 milligrams, and 25 milligrams), is designed to minimize the risk of unblinding. To further protect the blinding of the trial, COMPASS Pathways has decided to release data only after the 26-week time point has been reached for all patients. This decision was influenced by insights from the recent Lykos AdCom and the FDA's focus on unblinding issues in psychedelic drug trials.
Financial Strategy and Operational Adjustments
In addition to the trial updates, COMPASS Pathways announced a series of financial and operational adjustments to preserve cash and ensure the successful completion of the Phase III COMP360 trials. These adjustments include a workforce reduction of approximately 30% and the cessation of non-COMP360 preclinical efforts. The company is also exploring the potential externalization of its digital tools to a new company established by its co-founders.
According to Teri Loxam, CFO of COMPASS Pathways, the company had cash and cash equivalents of $207 million as of September 30, 2024. The company expects its cash runway to fund operations at least into 2026.
Commercialization Strategy
Lori Englebert, CCO of COMPASS Pathways, discussed the company's commercialization strategy for COMP360. She emphasized the significant unmet need in TRD and the potential for COMP360 to change the way patients are managed. The company is focused on ensuring appropriate billing codes are established, preparing states for DEA rescheduling, engaging with key opinion leaders, and investing in health economics research to prepare for future payer discussions.
COMPASS Pathways is also collaborating with select interventional psychiatry networks to gain insights into current operating models and identify opportunities to scale the COMP360 operating model. The goal is to ensure that delivery centers can fit COMP360 into their current operating infrastructure at launch and are prepared to support the expected demand for a new and novel treatment.
Addressing Unmet Needs in Treatment-Resistant Depression
Treatment-resistant depression (TRD) is a significant clinical challenge, with approximately one-third of patients treated for major depressive disorder failing to achieve remission after two therapies. Currently, there are only two FDA-approved pharmacologic treatments with a TRD indication. If approved, COMP360 has the potential to provide a new treatment option for patients who have not responded to existing therapies.
Despite the delays and operational challenges, COMPASS Pathways remains committed to the development of COMP360 and its potential to address the unmet needs in the treatment of depression. The company's financial strategy and ongoing clinical trials reflect a focused effort to bring this potential treatment to market while managing resources effectively.
