Novaremed Announces U.S. FDA Approval of IND Application to Initiate Phase 2 Clinical Study of NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy
Novaremed AG (Novaremed), a clinical-stage Swiss biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate its US-based Phase 2 clinical study of the novel drug candidate, NRD135S.E1, for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN).
The randomized, double-blind, placebo-controlled, multi-center study will have the primary objective of demonstrating the superiority of NRD135S.E1 over placebo in relieving PDPN in patients after 3 months of treatment.
“The acceptance of our IND is a major milestone in the clinical development of NRD135S.E1 for the treatment of PDPN,” said Sara Mangialaio, M.D., Ph.D., CMO and Head of R&D at Novaremed. “NRD135S.E1 may offer a much-needed non-opioid new treatment option to patients suffering from the disease and improve their quality of life substantially.”
“With the IND clearance from FDA, we are one step closer in the development of NRD135S.E1 to benefit millions of patients suffering from this debilitating disease,” said Subhasis Roy, M.Com, MBA, CEO/COO of Novaremed.
Novaremed is currently in discussions with potential investors to raise the necessary funding to initiate the Phase 2 clinical study and prepare for further late-stage development activities of NRD135S.E1.
Notes to the Editor:
Novaremed Ltd, a wholly owned subsidiary of Novaremed AG was founded in 2008 in Israel and Novaremed AG was founded in 2017 in Switzerland. Novaremed Ltd is developing NRD135S.E1, an orally active non-opioid small molecule with a novel mechanism of action against PDPN. In a Phase 2 Proof of Concept study, NRD135S.E1 showed clinically relevant reduction in patient-reported pain and an excellent safety and tolerability profile. Novaremed Ltd is currently preparing to conduct a Phase 2 study in USA.
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