Novaremed is seeking the approval of the US Food and Drug Administration (FDA) to begin a phase 2 trial for evaluating its new drug candidate NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy (PDPN).
In this connection, Novaremed has filed an investigational new drug (IND) application to the FDA.
The clinical-stage Swiss biopharma company revealed to have got initial feedback from the FDA during a pre-IND meeting held in last July. Following that, the company has designed the phase 2 study as a randomised, double-blind, placebo-controlled trial.
The mid-stage trial will have patients who are suffering from neuropathic pain due to diabetes mellitus.
Novaremed said that eligible patients for the phase 2 trial will be randomised to be subjected to oral doses of either NRD135S.E1 or placebo daily once for a period of three months.
Novaremed CMO and R&D head Sara Mangialaio said: “Submitting this IND is an important next step in the clinical development of NRD135S.E1 for the treatment of PDPN and we are moving rapidly to potentially address a global unmet medical need.
“We look forward to launching this Phase 2 study as soon as possible. This study will provide further important information about the safety and efficacy of NRD135S.E1, which was very well tolerated and induced a clinically relevant reduction in pain in the previous Phase 2 Proof of Concept study of 3-week duration.”
The company’s phase 2a Proof of Concept (PoC) was a three-week, placebo-controlled, randomised, multi-center study, which was held in Israel in 88 patients with diabetic peripheral neuropathy.
The Swiss biopharma company said that it is presently in talks with potential investors to raise the required funding to support in organising the proposed phase 2 study, and also for preparing further late-stage development activities of NRD135S.E1.
Novaremed CEO/COO Subhasis Roy said: “Safe and effective therapies are critical to provide patients and physicians with treatment alternatives for PDPN.
“The next steps announced today for NRD135S.E1 highlight the result of Novaremed’s many years of pursuit to move a novel non-opioid drug against PDPN as rapidly as possible.”