Novaremed: Phase 1 and Phase 2a study data for investigational non-opioid pain treatment

• Three Phase 1 studies displayed favorable pharmacokinetics and good tolerability of NRD.E1 after oral administration
• The Phase 2a, proof of concept study demonstrated clinically meaningful reductions in pain across primary and secondary endpoints and a benign side effect profile
• In summary, data from these 4 studies now published 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 US has selected and included NRD.E1 to the NIH-HEAL Initiative® under which the NIH sponsors and executes a Phase 2b trial with study recruitment starting in 3Q 2022

“We are delighted with the publication of our Phase 1 and Phase 2a studies which collectively demonstrate the drug candidate’s potential as an innovative non-opioid treatment option for patients with chronic pain,” said Eva Tiecke, PhD, Chief Scientific Officer and Head of R&D of 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 in pain reductions at 40 and 150 mg/day of 0.82 Numerical Rating Scale points, p = 0.034 and 0.66, p= 0.061, respectively, though it narrowly missed the pre-specified value of p = 0.016 due to multiplicity. Overall, the study showed robust results given the consistent performance across multiple endpoints. Based on the data now published in peer-reviewed journals, we are encouraged about the potential of NRD.E1 to address the high unmet medical need for a non-opioid agent to treat chronic pain.”

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 studies revealed dose-dependent absorption, small increased exposure to NRD.E1 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 investigated NRD.E1 at 10, 40, or 150 mg/day or placebo over a 3-week treatment period. 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.