Novaremed announces the publication of data from the phase 1 and phase 2a study with NRD.E1 demonstrating the potential of this experimental non-opioid pain treatment

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  • Three phase 1 studies have shown favorable pharmacokinetics and good tolerance of NRD.E1 after oral administration

  • Phase 2a proof-of-concept study demonstrated clinically meaningful pain reductions on primary and secondary endpoints and a mild side effect profile

  • In summary, the data from these 4 now published studies demonstrate the potential of NRD.E1 as an innovative non-opioid treatment option for patients with painful diabetic peripheral neuropathy (PDPN)

  • Based on available data, the National Institutes of Health (NIH) in the United States selected and included NRD.E1 in the NIH-HEAL Initiative® in which the NIH is sponsoring and running a Phase 2b trial with a recruitment for the study from the 3rd quarter of 2022

BASEL, Switzerland, June 23, 2022–(BUSINESS WIRE)–Novaremed AG, a private, clinical-stage biopharmaceutical company specializing in innovative non-opioid treatment options for the management of chronic pain, announces the simultaneous release of data from three Phase 1 studies in Clinical pharmacology in drug development and a Phase 2a proof-of-concept, placebo-controlled, dose-finding study in European Journal of Pain with the Company’s lead investigational drug candidate, NRD.E1, a novel non-opioid therapy for painful diabetic peripheral neuropathy.

“We are excited about the publication of our Phase 1 and Phase 2a studies which collectively demonstrate the potential of the drug candidate as an innovative non-opioid treatment option for patients with chronic pain,” said Eva Tiecke, PhD, Scientific Director and Head of R&D at Novaremed and lead author of both publications. “In the Phase 2a proof-of-concept study, the primary endpoint showed a clinically relevant placebo-corrected treatment effect on pain reduction at 40 and 150 mg/day of 0.82 points over the rating scale, p=0.034 and 0.66, p=0.061, respectively, although it narrowly missed the pre-specified value of p=0.016 due to multiplicity. “study showed robust results considering consistent performance across multiple endpoints. Based on data now published in peer-reviewed journals, we are encouraged by the potential of NRD.E1 to address the medical need high unsatisfied with a non-opioid agent to treat chronic pain.

In three phase 1 studies, NRD.E1 was well tolerated at a single dose up to 1200 mg and at multiple doses of 300 mg/day for five consecutive days. Studies revealed dose-dependent absorption, a small increase in NRD.E1 exposure at peak when administered with food, and no relevant accumulation after oral administration. The phase 2a study was a randomized, double-blind, placebo-controlled, dose-finding, proof-of-concept study in 88 patients with PDPN. The study involved NRD.E1 at 10, 40 or 150 mg/day or placebo over a 3 week treatment period. Analyzes of primary, pre-specified secondary, and post-hoc endpoints consistently demonstrate clinically meaningful pain reduction. NRD.E1 was safe and well tolerated.

References:

[1] Tiecke E., Rainisio M., Guentert T., Müller S., Hochman L., Kaplan E., Mangialaio S. (2022). First-in-human single-dose, multiple-dose, and food-interaction studies of NRD.E1, an innovative non-opioid treatment for painful diabetic peripheral neuropathy. Clinical Pharmacology in Drug Development (CPDD) (https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1103).

[2] Tiecke E., Rainisio M., Eisenberg E., Wainstein J., Kaplan E., Silverberg M., Hochman L., Mangialaio S. (2022) NRD.E1, an innovative non-opioid therapy for painful diabetic peripheral neuropathy – a randomized proof-of-concept study. European Journal of Pain (https://onlinelibrary.wiley.com/doi/10.1002/ejp.1989).

About NRD.E1 and treatment of chronic pain
NRD.E1, an orally active small molecule with a novel mechanism of action and patent protection until 2040, is Novaremed’s lead compound currently being developed to treat PDPN.

Based on the now published results, NRD.E1 has been selected by the NIH as the only oral agent to be included in the NIH-HEAL (Help End Long-term Addiction) program. The NIH will sponsor and execute by and conducted by EPPIC-Net (Early Phase Pain Investigation Clinical Network) a 12-week, double-blind, placebo-controlled Phase 2b study in patients with moderate to severe PDPN in the United States. Novaremed has an open IND and received FDA Fast Track designation for NRD.E1.

About Novaremed
Novaremed AG, a privately held, clinical-stage biopharmaceutical company, is developing a pipeline of innovative drugs for the management of chronic pain to address the high unmet medical need for improved pain relief and as an alternative to opioids. Its lead product is NRD.E1, an orally active, non-opioid small molecule with a novel mechanism of action, has obtained FDA Fast Track designation and IND approval to proceed to a Phase 2b clinical trial for the treatment of painful diabetic peripheral neuropathy (PDPN). Earlier stage chronic pain pipeline includes development candidates MP-101 (early clinical development stage) and MP-103 (preclinical stage), targeting the unmet medical need for prevention and treatment of induced peripheral neuropathy by chemotherapy (NPCI). For more information: www.novaremed.com.

Read the full press release at www.novaremed.com or click here.

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contacts

Mark Altmeyer, Executive Board Member
[email protected]

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