NRD.E1 / Novaremed, NeuroFront - LARVOL DELTA

Novaremed Announces Completion of Enrollment in NIH-sponsored Phase 2b Study with Non-opioid NRD.E1 for the Treatment of Chronic Pain Associated with Diabetic Peripheral Neuropathy (GlobeNewswire) - "Novaremed AG, a privately held clinical-stage biopharmaceutical company, announces that recruitment is completed in the National Institutes of Health (NIH) -sponsored Phase 2b EN21-01 trial (ClinicalTrials.gov identifier NCT05480228). The study evaluates Novaremed’s non-opioid investigational drug NRD.E1 for the treatment of chronic pain associated with diabetic peripheral neuropathy, and is funded by the NIH Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative....Study completion, with the last patient’s last visit (LPLV), is anticipated in Q3 2025 and the topline results are expected in Q4 2025."

Enrollment closed • P2b data • Trial completion date • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

EN21-01: EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA (clinicaltrials.gov) - P2 | N=122 | Recruiting | Sponsor: James P. Rathmell, MD | Trial completion date: Jan 2025 ➔ May 2025 | Trial primary completion date: Jan 2025 ➔ May 2025

Trial completion date • Trial primary completion date • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

The Early Phase Pain Investigation Clinical Network for Non-addictive Pain Therapeutics Trials. (IASP 2024) - "The first trial (A 24-week study to evaluate the safety and efficacy of CNTX-6970 in subjects with moderate to severe knee osteoarthritis pain) evaluates the safety and efficacy of a novel oral drug for treatment of patients with moderate to severe knee osteoarthritis pain and recently finished enrolling patients. The second funded trial (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of 80 mg daily of NRD135S.E1 Versus Placebo in Adult and Elderly Participants with Painful Diabetic Peripheral Neuropathy) is of a novel oral small molecule targeting PDPN being studied under the platform protocol, and is currently open to enrollment... EPPIC-Net welcomes applications for assets that target pain conditions lacking adequate treatment. Applications are accepted and reviewed on a rolling basis. Applicants provide clinical-grade asset for the trial and retain asset ownership and intellectual property rights."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Diabetic Neuropathy • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Peripheral Neuropathic Pain • Psychiatry • Rheumatology

EN21-01: EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA (clinicaltrials.gov) - P2 | N=122 | Recruiting | Sponsor: James P. Rathmell, MD | Trial completion date: Dec 2023 ➔ Jan 2025 | Trial primary completion date: Sep 2023 ➔ Jan 2025

Trial completion date • Trial primary completion date • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

EN21-01: EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA (clinicaltrials.gov) - P2 | N=122 | Recruiting | Sponsor: James P. Rathmell, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

EN21-01: EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA (clinicaltrials.gov) - P2 | N=122 | Not yet recruiting | Sponsor: James P. Rathmell, MD

New P2 trial • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

Novaremed enters into an exclusive option and license agreement with NeuroFront for the non-opioid neuropathic pain treatment, NRD.E1, for Greater China and Singapore (Novaremed Press Release) - "Novaremed AG and NeuroFront Therapeutics (Hong Kong) Limited jointly announce the signing of an exclusive collaboration and commercialization agreement for Novaremed’s innovative non-opioid investigational drug, NRD.E1, being developed for the treatment of diabetes-related neuropathic pain and other neuropathic pain indications. Under the terms of the agreement, Novaremed is eligible to receive from NeuroFront over USD 130 million in option and exercise fees as well as development, regulatory and sales milestone payments plus royalties on net sales....The agreement allows NeuroFront to develop and commercialize NRD.E1 as treatment of painful diabetic peripheral neuropathy (PDPN) and any other neuropathic pain indications in the Greater China territory (including Mainland China, Hong Kong, Macau, and Taiwan) and Singapore."

Licensing / partnership • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Novaremed Announces Publication of Phase 1 and Phase 2a Study Data With NRD.E1 Demonstrating the Potential of This Investigational Non-opioid Pain Treatment (Businesswire) - P1 | N=NA | P2 | N=88 | NCT02345291 | Sponsor: Novaremed Ltd. | "Novaremed AG...announces the simultaneous publication of data from three Phase 1 studies in Clinical Pharmacology in Drug Development and one Phase 2a, placebo-controlled, dose-finding, proof of concept study in European Journal of Pain with the Company’s lead investigational drug candidate NRD.E1, an innovative non-opioid therapy for painful diabetic peripheral neuropathy....In three Phase 1 studies NRD.E1 was well tolerated as single dose up to 1200 mg and repeated doses of 300 mg/day for five consecutive days....The Phase 2a study was a randomized, double-blind, placebo-controlled, dose-finding, proof-of-concept study in 88 patients with PDPN....Primary, pre-specified secondary and post-hoc secondary endpoints analyses consistently demonstrate a clinically meaningful reduction in pain. NRD.E1 was safe and well tolerated."

P1 data • P2 data • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

First-in-Human Single-Ascending-Dose, Multiple-Dose, and Food Interaction Studies of NRD.E1, an Innovative Nonopioid Therapy for Painful Diabetic Peripheral Neuropathy. (PubMed, Clin Pharmacol Drug Dev) - "All 3 phase I studies consistently showed rapid absorption of orally administered NRD.E1 followed by fast elimination, mainly via metabolization (glucuronidation), and small secondary increases in plasma concentrations. NRD.E1 was well tolerated, with no subject discontinuation due to treatment-emergent adverse events in any study."

Journal • P1 data • Diabetic Neuropathy • Pain • Peripheral Neuropathic Pain

NRD.E1, an innovative non-opioid therapy for painful diabetic peripheral neuropathy - a randomised proof of concept study. (PubMed, Eur J Pain) - "The data suggest that NRD.E1 potentially represents a novel non-opioid therapeutic option for patients with PDPN, with at least similar efficacy and better tolerability than available therapies, justifying its further evaluation in larger-scale confirmatory studies."

Journal • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Peripheral Neuropathic Pain

Novaremed’s Non-opioid Lead Compound, NRD.E1, to be Tested in NIH HEAL Initiative Phase 2 Trial for the Treatment of Chronic Pain (Businesswire) - "Novaremed AG...announces a study with the National Institutes of Health (NIH) under which the NIH will sponsor and conduct a clinical Phase 2b study with Novaremed’s lead non-opioid development compound NRD.E1 in the treatment of painful diabetic peripheral neuropathy (PDPN)....The NIH-supported Phase 2b trial EN21-01, named SERENDIPITY-1, is a 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of NRD.E1 versus placebo in 260 adult and elderly patients with PDNP. The primary efficacy endpoint aims to demonstrate superiority of NRD.E1 compared to placebo in relieving PDPN....The study is planned to start in the second quarter of 2022."

New P2b trial • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Novaremed Expands its Pipeline of Non-opioid Treatment Candidates for Chronic Pain Indications Through Acquisition of Metys Pharmaceuticals (Businesswire) - "Novaremed AG...announces the acquisition of Metys Pharmaceuticals AG (Metys), including all of its development programs, in an all-share transaction. The acquisition broadens Novaremed’s existing pipeline by adding both clinical and preclinical development projects based on an innovative approach for non-opioid chronic pain treatment, the Company’s focus area. Moreover, it enables Novaremed to target a wider spectrum of neuropathic pain indications, potentially also addressing broader applications by including prevention in addition to the treatment of pain...NRD.E1, an orally active small molecule with a novel mechanism of action and patent protection until 2040...MP-101...The Phase 2 trial is expected to start in the first quarter of 2023."

M&A • New P2 trial • Patent • CNS Disorders • Pain • Peripheral Neuropathic Pain

Novaremed Secures US $50 Million Capital Commitment from Global Emerging Markets (Businesswire) - "Novaremed...announced today that it has signed an agreement with GEM Global Yield LLC SCS (GEM)...Under the agreement, GEM commits to provide Novaremed with a share subscription facility of up to US $50 million for a 36-month term following the public listing of the company’s shares...the proceeds from this financing will be used to progress the clinical development of Novaremed’s lead product, NRD135S.E1, an investigational non-opioid small molecule drug for the treatment of painful diabetic peripheral neuropathy (PDPN)."

Financing • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Novaremed Receives Fast Track Designation from the FDA for NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy (Businesswire) - "Novaremed...announced today that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the development of NRD135S.E1 for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN)...we plan to initiate our Phase 2b study..."

Fast track designation • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Novaremed Announces Closing of a New Financing, Publication of PCT Patent Application and Participation at IASP Virtual Conference on Pain & Expo (Businesswire) - "Novaremed AG...today announced that it has raised CHF2.5 million from its existing shareholders in an oversubscribed new financing round....The additional proceeds will be used to prepare for the initiation of a Phase 2b clinical study in the US of its novel drug candidate, NRD135S.E1, for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN)....Novaremed also announced today that its PCT patent application covering a targeted therapy to treat pain and inflammation was published on July 30, 2020 (Publication No. WO 2020/1522226)....The national patent applications, if granted, will provide protection for Novaremed’s technology without a gap in patent protection until 2039/40....Novaremed is participating at International Association for the Study of Pain (IASP) sponsored conference 'Virtual Series on Pain & Expo'...poster abstract on the results of the Phase 2a Proof of Concept study has been accepted for the virtual poster gallery."

Financing • P2a data • Patent • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

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 (Businesswire) - "Novaremed AG...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)....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."

IND • New P2 trial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Novaremed announces IND submitted to U.S. FDA for phase 2 study of NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy; also announces the appointment of three new board members (Businesswire) - "Novaremed AG...today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the novel drug candidate (NRD135S.E1) for the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) to evaluate NRD135S.E1 in a Phase 2 study....'We look forward to launching this Phase 2 study as soon as possible.'"

IND • New P2 trial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Novaremed secures additional financing and strengthens leadership (Businesswire) - "Novaremed AG...today announced that it has secured CHF2.6 million in additional financing from its existing shareholders and several new private investors. This brings the total financing raised by the company, since its inception, to CHF21 million....The recent funding...accelerates its preparation towards initiating a Phase 2b study in Diabetic Neuropathic Pain (DNP)."

Financing