- SNX-5422 has been granted Orphan Drug Status for neuroendocrine tumors by the FDA
- SNX-5422 is an orally active Hsp90 inhibitor that has provided durable clinical responses in open label trials in non-small cell lung cancer (NSCLC) and neuroendocrine tumors
Esanex, Inc. announced on 8/4/18 the successful conclusion of meetings with the U.S. Food and Drug Administration (FDA) that have outlined a clinical path toward registration for SNX-5422 in neuroendocrine tumors (NETs). Agreement was reached on trial design, endpoints and statistical control methods. Esanex also announced that SNX-5422 has been granted Orphan Drug Status for this indication by the FDA.
“While survival for all NETs has improved over time there remains an urgent need for new treatment options,” said Steve Hall, Ph.D., President and Chief Executive Officer of Esanex, Inc. “Based on positive results presented at the North American Neuroendocrine Society (NANETS) annual meeting in 2017, we believe that SNX-5422 has the potential to provide a new therapeutic approach for patients living with NETs. We are pleased with the outcome of our End-of-Phase 2 discussions with the FDA. We appreciate the valuable guidance the FDA has already provided us and look forward to continuing a constructive relationship as we advance our Phase 3 registration program.”
SNX-5422 was studied in combination with everolimus and showed promising signs of clinical activity in subjects with advanced NETs. The objective response rate in a subset of subjects who had entry criteria similar to that seen in the registrational study for everolimus alone (RADIANT-4) was 50%, compared to 2% seen in that study. Multiple subjects remained on the combination for prolonged periods of time, including 2 subjects for ≥30 months.
SNX-5422 is a chemically unique, orally active Hsp90 inhibitor that has provided durable clinical responses in open label trials in non-small cell lung cancer (NSCLC) and neuroendocrine tumors (NET). With approximately 200 patients treated to date, SNX-5422 has a well-established safety profile that supports studying it as monotherapy and in combination with existing approved drugs in a variety of clinical settings.