Relmada Revives Hopes with Innovative Protocol Following Two Phase III Failures

Relmada Therapeutics has announced a crucial modification to its clinical assessment of REL-1017 as a potential supplemental therapy for major depressive disorder (MDD), following the disappointing results of two Phase III trials. This adjustment could be pivotal in determining the drug’s efficacy and impact on MDD treatment.

The Florida-based biotech is altering its Phase III Study 302 with the aim of wrapping up the trial by the end of 2023. At the same time, a separate study is underway to assess the safety of its product, REL-1017, with an expected completion date of July 2023. With these two studies in motion, the biotech is getting ever closer to revolutionizing the medical landscape.

Relmada recently made a successful amendment to Study 302 that is now in effect. This protocol adjustment ensures that the study will move forward with even greater accuracy and efficiency.

Relmada is thrilled to announce the launch of Study 304, a new trial set to begin enrollment by mid-2023. The protocol for this study has been carefully crafted and promises to provide groundbreaking insights into the field of medicine. We are excited to start this journey and look forward to the potential discoveries it may bring.

On Thursday, Relmada CEO Sergio Traversa highlighted two key factors for success in depression trials: recruiting the right participants who are clinically diagnosed with Major Depressive Disorder (MDD) and effectively managing the placebo response. With these pieces in place, he expressed confidence in the potential of these trials to yield meaningful results.

The Phase III data the company has seen has differed from its Phase II data, and Traversa believes this can be explained by the identification of certain issues.

REL-1017, an investigational NDMA receptor channel blocker, has failed to meet its primary endpoint in Reliance I, Study 301, as reported in December 2022. This has prompted a re-evaluation of the results and a shift in approach to address the challenge.

At the 28-day follow-up, patients taking REL-1017 saw their Montgomery-Asberg Depression Rating Scale scores drop by 15.1 points, while those taking placebo saw a decrease of 12.9 – a difference of 2.2 points that failed to reach statistical significance. In 2022, this Phase III flop became the second in a row for REL-1017, a drug hopeful for treating depression.

In October 2022, Relmada reported that its Reliance III trial had failed to meet its primary endpoint, with the results proving to be paradoxical. This unexpected outcome has raised many questions, leaving the pharmaceutical industry to ponder the future of this promising drug.

After running an analysis to better understand the puzzling data, the company discovered a significant distinction between REL-1017 and placebo when excluding trial sites with “implausibly high or low placebo responses.”

Surprising results were observed in the placebo arm of the trial, with significantly higher results than anticipated being seen across certain trial sites.

By relying on self-reported medical history from the subjects, regardless of whether the source of recruitment was verified or unverified, previous studies have been limited in their accuracy and utility. However, Dr. Traversa’s research takes a different approach, providing a more comprehensive understanding of the subject matter.

After thorough examination, it was determined that the vetting of subjects was not satisfactory. Consequently, further investigation is needed to ensure that appropriate standards are met.

Relmada has appointed CNS therapeutics expert, Cedric O’Gorman, as its new Chief Medical Officer. O’Gorman brings with him experience and knowledge in the field, as well as a newfound focus on site selection. He looks forward to helping Relmada further its mission of providing top-notch care and service.

The company plans to cap the number of patients per site in order to ensure that no single site has an excessive influence on the study results. This way, the outcomes of the study will remain as accurate and reliable as possible.

In a bid to streamline the study protocols, O’Gorman and his team have sought the advice of experts to decrease the length of site visits and assessments. This shift marks the company’s commitment to making the protocols more efficient.

An in-depth analysis from experts determined that Study 301’s site visits were overly lengthy and had too many assessments, leading to an increase in the placebo response.

Traversa is confident that all the necessary components are now in place to ensure a successful filing of the New Drug Application (NDA) for REL-1017. With the completion of this crucial step, progress is being made towards bringing this much-needed medication to the public.

FDA has granted Fast Track Designation for a new therapy to treat Major Depressive Disorder (MDD), set to be available as early as August 2022. This groundbreaking development provides hope for those struggling with MDD, providing an alternative treatment to help manage their symptoms and improve quality of life.

At the close of 2022, Relmada had a remarkable $148.2 million on hand, allowing them an impressive two-year “runway” of cash, as CFO Maged Shenouda noted during an investor call. This significant sum of money gives them the resources needed to pursue exciting opportunities.

Leave a Comment