Release Date: May 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Relmada Therapeutics Inc (RLMD, Financial) reported progress in their ongoing Phase three program for REL-1017 in major depressive disorder, with positive modifications to control placebo response and improve patient profiles.
- The company has implemented a comprehensive adjudication process to ensure high-quality patient enrollment, which is expected to enhance the probability of success in ongoing studies.
- Relmada Therapeutics Inc (RLMD) has completed all necessary preclinical manufacturing and Phase one studies required for a potential REL-1017 NDA filing, focusing now on executing the remaining Phase three studies.
- The initiation of a Phase one clinical trial for a modified release formulation of psilocybin is anticipated in the first half of the year, with potential beneficial effects on metabolic parameters in obesity and liver disease.
- Relmada Therapeutics Inc (RLMD) maintains a strong financial position with sufficient cash on hand to support operations comfortably into 2025.
Negative Points
- The company reported a net loss of $21.8 million for the first quarter of 2024, although this was an improvement from the previous year's loss of $26.3 million.
- There was a decrease in cash equivalents and short-term investments from $96.3 million as of December 31, 2023, to $83.6 million as of March 31, 2024.
- The screening failure rate in the RELIANCE two study has increased to approximately 80%, indicating stringent enrollment criteria that could potentially slow down the enrollment process.
- There are ongoing challenges with site and patient management in clinical trials, including the need to close or pause enrollment at sites that do not meet quality standards.
- Competition in the depression treatment landscape, particularly with the rise of studies involving psilocybin and other treatments, poses a challenge for patient recruitment and trial progress.
Q & A Highlights
Q: Can you provide some color about the blinded data from the Reliance and Relight trials compared to the prior trial that had a larger placebo response?
A: Sergio Traversa, CEO of Relmada Therapeutics, explained that monitoring blinded data helps identify inconsistencies like zigzag patterns in patient scores, which indicate issues at certain sites or with specific patients. This monitoring helps ensure the quality and consistency necessary for the trial's success. Andrew Cutler, Senior Clinical Development Advisor, added that the company is now more stringent with site enrollments to maintain high-quality data.
Q: What steps do you take to remediate issues when inconsistencies are observed at trial sites?
A: Sergio Traversa stated that the initial step involves contacting the site to discuss inconsistencies. If a pattern of issues emerges, the ultimate measure might be to close the site to prevent trial impact. Andrew Cutler emphasized the importance of not allowing problematic sites to continue enrolling patients, which could jeopardize the trial.
Q: Are there any interim analyses planned for the ongoing trials, and will the DSMB recommend stopping the study early?
A: Sergio Traversa clarified that there is no planned interim analysis that would incur a statistical penalty, but a simple re-estimation by the data monitoring committee will occur near the trial's end to determine if the sample size is sufficient or needs to be expanded. He also mentioned that the DSMB primarily monitors safety, and the safety profile has been satisfactory.
Q: How do you handle the competition in recruiting patients for depression studies, especially with the rise of studies in adjacent therapeutic areas like schizophrenia and epilepsy?
A: Sergio Traversa acknowledged the competition but noted that it is less intense for their specific indication of adjunctive treatment in depression. He mentioned that while there are other studies, the direct competition remains low, allowing them to effectively recruit and retain suitable study participants.
Q: Could you describe the design of the upcoming Phase one psilocybin program and what constitutes positive data?
A: Sergio Traversa described the Phase one trial as a single ascending dose study in obese patients, which is unusual since Phase one trials typically involve healthy volunteers. The focus will be on pharmacokinetic and safety data, with the trial expected to be relatively short, lasting three to four months.
Q: What is the current screening failure rate in your trials, and how has it changed with new protocols?
A: Sergio Traversa indicated that the screening failure rate is high due to stringent criteria like drug-drug interactions. However, they continuously review and adjust protocols in response to site feedback to optimize the balance between enrollment rates and maintaining trial integrity. The requirement for medical and pharmacy records has increased the screening failure rate but also improved the quality of enrolled patients.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
