Novaremed is a clinical-stage Swiss biopharmaceutical developing NRD135S.E1 (NRD.E1), an orally available, non-opioid small molecule for painful diabetic peripheral neuropathy (PDPN). NRD.E1 has a novel mechanism that does not bind to pain-associated or opioid receptors. Completed clinical work includes three Phase I studies and a Phase IIa randomized, placebo-controlled dose-finding study in 88 PDPN patients that showed clinically relevant, dose-related pain reduction and good tolerability. The company holds an open IND and is preparing a 12-week Phase II study in 120 US patients to assess efficacy, safety, withdrawal symptoms, and effects on insomnia and quality of life. In December 2020 the FDA granted NRD.E1 Fast Track designation for the treatment of PDPN. Novaremed Ltd was founded in 2008 in Israel and Novaremed AG in 2017 in Switzerland; the company aims to advance NRD.E1 toward registration while avoiding opioid-related addiction risks. Novaremed is a clinical-stage Swiss biopharmaceutical company developing NRD135S.E1, an orally active non-opioid small molecule targeting Painful Diabetic Peripheral Neuropathy (PDPN). In a Phase 2a proof-of-concept study, NRD135S.E1 showed clinically relevant reductions in patient-reported pain and an excellent safety and tolerability profile. The company received FDA IND clearance to initiate a Phase 2b clinical study in the U.S. and is preparing to begin that trial. Novaremed closed an oversubscribed financing of CHF2.5 million from existing shareholders, bringing total financing since inception to CHF23.5 million. The company published a PCT patent application (Publication No. WO 2020/1522226) covering compounds for treating pain, inflammation and/or autoimmunity, enabling filings in major countries with potential protection through 2039/40. Novaremed Ltd was founded in Israel in 2008 and Novaremed AG in Switzerland in 2017; the company is also participating in the IASP Virtual Series on Pain & Expo to present its Phase 2a results. Novaremed is developing NRD.E1, an orally active non-opioid small molecule with a novel mechanism of action for treating diabetic neuropathic pain. In a Phase 2a proof-of-concept study, NRD.E1 showed a clinically relevant reduction in patient-reported pain. The company received positive feedback from the FDA following a Pre-IND meeting, which defines the path forward for opening the IND for a Phase 2b study. Novaremed is preparing for a global Phase 2b study in DNP, expected to start in Q2/3 2020. Financially, the company secured CHF2.6 million in additional financing, bringing total financing since inception to CHF21 million. Leadership was recently strengthened as Subhasis Roy, COO since April 2018, was named Interim CEO. Novaremed was founded in 2008 in Israel and transferred its headquarters to Novaremed AG in Switzerland in November 2017. Novaremed is developing NRD.E1, a once-daily, orally available, first-in-class small molecule allosteric modulator of Lyn Kinase for diabetic neuropathic pain (DNP). NRD.E1 completed a 3-week, placebo-controlled, randomized Phase 2a proof-of-concept study in 88 DNP patients that showed a clinically relevant reduction in patient-reported pain and was well tolerated. The company plans a global Phase 2b clinical study of NRD.E1, expected to be initiated in H2 2019, and intends to explore additional indications as part of lifecycle management supported by animal-model efficacy. Novaremed was founded in 2008 in Israel and was incorporated in Switzerland (Basel) in early 2018 to support rapid global clinical development. Financially, the company recently raised additional funding and, together with prior financing, says it is well capitalized to prepare for the Phase 2b study.

Total raised

$61M

Funding rounds

4

Latest round

Equity

Latest activity

Jan 2021