Denovo Biopharma said today it has exclusively licensed pomaglumetad methionil (mGlu2/3 receptor agonist), a late-stage neuroscience drug, from Eli Lilly for an undisclosed price.
The deal comes nearly two and a half years after Lilly halted Phase III development of pomaglumetad (DB103, formerly LY2140023) as a schizophrenia treatment, after an independent analysis of data from a second Phase III study (designated HBBN) concluded that the drug simply didn’t seem to work.
The first Phase III study, HBBM, also showed disappointing results for pomaglumetad—namely that it did not separate from placebo in the primary efficacy endpoint in either the overall or predefined genetic subpopulation (based on the Positive and Negative Syndrome Scale, PANSS) at two doses investigated (40 mg and 80 mg BID).
Pomaglumetad was primarily developed and tested in schizophrenia, including in Phase II and Phase III clinical trials. While pomaglumetad did not meet the primary endpoint in the intent-to-treat population in Phase III studies, Denovo said “a meaningful subset” of patients who showed significantly improved outcomes had been identified through predefined sub-population analysis and post-hoc analysis across multiple studies. That meaningful subset was not identified by the company in today’s statement.
Under today’s licensing deal, Denovo gains all rights to develop, manufacture, and commercialize pomaglumetad globally, including transfer of all intellectual property and other rights, data, and information. Lilly has an option to re-acquire pomaglumetad upon a successful clinical trial, for predetermined but undisclosed financial terms.
“Lilly is a world leader in the development of neuroscience drugs and will be a valuable collaborator in pomaglumetad's continued development,” Denovo COO Michael F. Haller, Ph.D., said in the statement.
Denovo said it will use its platform to identify genetic biomarkers as a companion diagnostic to screen for appropriate patient subsets in future clinical trials and eventual commercialization.
The company specializes in re-evaluating medicines that have failed in general patient populations by studying them in the original indication in biomarker-selected sub-populations. By identifying biomarkers correlated with patients' responses to drug candidates retrospectively, Denovo seeks to enable design and execution of follow-on clinical trials in targeted patient populations with increased likelihood of success.
The pomaglumetad deal is the second in six months in which Denovo has enhanced its portfolio with a failed late-stage Lilly drug candidate. In September 2014, Denovo acquired the late-stage cancer drug enzastaurin from Lilly for an undisclosed price. Lilly halted development of enzastaurin in 2013 after it failed the Phase III PRELUDE study, which assessed the drug candidate as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL).
The enzastaurin deal also involved Denovo receiving all rights to develop, manufacture, and commercialize the drug globally, including transfer of all intellectual property and other rights, data, and information.