Novaremed Expands its Pipeline of Non-opioid Treatment Candidates for Chronic Pain Indications Through Acquisition of Metys Pharmaceuticals
Novaremed AG, a privately held clinical-stage biopharmaceutical company, 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. On the corporate side, Novaremed is strengthening its leadership team with a new board member, Andrew J. Oakley.
“The acquisition of Metys perfectly fits our strategy of pioneering the development of non-opioid pain treatments, aiming to deliver effective and well tolerated medications to patients while simultaneously addressing the urgent need for non-addictive treatments. I am delighted that industry expert Andrew Oakley is joining Novaremed’s Board of Directors and look forward to his support in the pursuit of our ambitious goals,” said Isaac Kobrin, Executive Chairman of the Board of Novaremed. “Our key objectives for the coming months are threefold: we plan to initiate the Phase 2b study with our promising lead candidate NDR.E1 for the treatment of painful diabetic peripheral neuropathy (PDPN), advance our new pipeline candidates from the Metys acquisition and, in parallel, will approach private and institutional investors to raise additional capital to support our pipeline which bears potential to provide next generation pain therapies.”
“I am pleased and excited about the acquisition of Metys by Novaremed as it represents a validation of our unique approach to the management of the progressive symptoms of peripheral sensory neuropathy. We have a clear pathway for our Phase 2 candidate MP-101 for the management of chemotherapy-induced painful symptoms of peripheral neuropathy, and our preclinical candidate MP-103 is being prepared for Phase 1,” said Michael Scherz, PhD, founder and Chief Executive Officer of Metys Pharmaceuticals. “We share the commitment to provide novel therapies to prevent, reduce or alleviate the burden of chronic pain and improve patient’s quality of life, thereby addressing an urgent unmet medical need and ultimately also reducing overreliance on opioids. Integrating Metys’ technologies and pipeline into Novaremed represents the best way forward towards accomplishing these goals.”
Broader pipeline of non-opioid development candidates
Going forward, Novaremed’s pipeline to address neuropathic pain will focus on three non-opioid development projects with entirely different modes of action:
NRD.E1, an orally active small molecule with a novel mechanism of action and patent protection until 2040, acts as a Lyn kinase modulator and is the Company's lead compound being developed to treat PDPN. Novaremed successfully completed a double-blind, placebo-controlled Phase 2a dose-finding proof-of-concept study in which NRD.E1 showed a clinically relevant reduction in patient-reported pain (measured as an improvement in mean neuropathic pain score) and was very well tolerated at all doses tested. Moreover, the results suggested similar or greater pain relief, and better tolerability than reported for standard approved therapies. On the basis of these positive results, Novaremed is ready to proceed with a 12-week, double-blind, placebo-controlled Phase 2b study in patients with moderate to severe PDPN in the US, where it has an open IND and Fast Track Designation from the FDA.
MP-101, a Phase 2 clinical candidate, is an orally available modulator of glutamate signaling. It works by preventing or reversing the ramped-up signaling that occurs in the spine and brain as a result of damaged peripheral nerves. MP-101 is a patented non-racemic mixture of the dimiracetam enantiomers with patent protection until 2039. In previous Phase 1 and Phase 2 clinical studies, in a total of 176 human subjects, a benign safety and tolerability profile comparable to placebo was noted for dimiracetam, and no signs or symptoms of sedation, dependence or withdrawal symptoms emerged. Based on pre-clinical proof of concept trials of chemotherapy-related neuropathy and pre-IND discussions with the FDA, MP-101 is being developed for the management of chemotherapy-induced neuropathy and neuropathic pain. The Phase 2 trial is expected to start in the first quarter of 2023.
MP-103, a glutamate signaling modulator orally active in diverse rodent models for prevention and treatment of peripheral nerve injury symptoms, is set to start of Phase 1 clinical development in the first half of 2023.
Enlarged pipeline addresses a high unmet medical need with a wider indication focus
With its three development candidates, Novaremed seeks to address a wider spectrum of neuropathic pain, including the most common forms of painful diabetic peripheral neuropathy (PDPN) and chemotherapy-induced peripheral neuropathy (CIPN). Sensory symptoms of peripheral neuropathy, including neuropathic pain are highly prevalent conditions, and their incidence is rising as both diabetes and cancer become more frequent. 1 in 5 diabetes patients develops PDPN and half of them require treatment due to the severity of symptoms. In cancer, 4 in 5 patients undergoing neurotoxic chemotherapy develop CIPN, highlighting the necessity for early intervention or prevention. Novel treatments for these often debilitating and intractable chronic pain conditions are urgently needed due to limited efficacy and poor tolerability of many standard of care therapies. Importantly, Novaremed’s non-opioid pipeline also aims to address the high medical need for treatments without a risk of physical dependence and abuse, an inherent danger with commonly prescribed opioid-based therapies. Novaremed sees potential for its pipeline candidates beyond PDPN and CIPN and intends to evaluate opportunities in additional neuropathic pain indications, thereby further widening its initial indication focus.
Strengthening the leadership team
Andrew J. Oakley, Board member of Metys, will join the Board of Directors of Novaremed. He is an experienced pharmaceutical and biotech industry professional and currently serves as Chief Financial Officer of Autolus Therapeutics (NASDAQ: AUTL). Previously, he held CFO positions at listed pharmaceutical companies Sosei Group (TSE:4565), Vectura Group plc (LSE: VEC) and Actelion Ltd, where he led the finance function for over a decade. Before joining Actelion, Andrew held senior finance positions for Accenture as well as executive positions in major multinational building material companies. Andrew holds a Bachelor of Economics Degree from Macquarie University and an MBA from London Business School and has been a Member of the Australian Institute of Chartered Accountants since 1987.
Novaremed AG, a privately held clinical-stage biopharmaceutical company, is innovating chronic pain management through the development of effective and safe treatment options 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 FDA Fast Track Designation and IND-approval to proceed with a Phase 2b clinical trial for the treatment of painful diabetic peripheral neuropathy (PDPN). The earlier stage pipeline addressing chronic pain includes the development candidates MP-101 (Phase 2 stage), targeting prevention and treatment of chemotherapy-induced peripheral neuropathy (CIPN), and MP-103 (preclinical stage). Novaremed’s clinical development portfolio aims to satisfy high medical patient needs and societal demands by alleviating the burden of pain associated with diabetes and cancer for patients and countering overreliance on addictive treatments. Novaremed Ltd (Israel) and Metys Pharmaceuticals AG (Switzerland) are fully-owned subsidiaries of Novaremed AG, domiciled in Basel (Switzerland). For more information: www.novaremed.com.
# # #
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Isaac Kobrin, M.D., Executive Chairman of the Board
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Verimatrix To Debut New App Monitoring SaaS Service at Money 20/20 Europe20.9.2021 17:45:00 CEST | Press release
Regulatory News: Verimatrix, (Euronext Paris: VMX) (Paris:VMX), the leader in powering the modern connected world with people-centered security, today announced it’s scheduled to unveil a new mobile application monitoring service, an extension of its award-winning App Shield and Code Protection solutions, during this week’s Money 20/20 Europe in-person event. Taking place September 21-23 in booth D140 at RAI Amsterdam, Verimatrix’s launch of its security monitoring service for mobile applications can assist both new and existing customers in gaining the intelligence and protections needed for mission-critical apps. The new monitoring solution is available for both Verimatrix App Shield and Verimatrix Code Protection. App Shield is a no-code SaaS service that brings unprecedented cybersecurity protection to any Android or iOS app. Developers simply upload their app to the Verimatrix App Shield platform and receive a secured version that’s ready to publish to an app store, a critical las
Citi, IFC and Global Bank Partner to Finance Women’s Economic Empowerment in Panama20.9.2021 16:08:00 CEST | Press release
Citi, Global Bank and the International Finance Corporation (IFC) have partnered to provide more mortgages and Small Medium Enterprise (SME) business loans to women. The joint initiative offers a first-of-its-kind co-lending transaction of a $90 million loan ($20 million funded by Citi for three years and $70 million funded by IFC for five years) to Global Bank. The proceeds from this loan will be used for either Low Income Housing Mortgages–Hipoteca Preferencial–for women as heads of household or for women-owned and-or women-led enterprises. In addition, Global Bank will also partner with IFC Advisory Services to further enhance and develop gender-focused products and services in Panama. “It’s an honor to support groups and institutions that seek to broaden women empowerment across the region as well as to place women at the center of Panama’s recovery from the coronavirus pandemic,” said Marcelo Gorrini, Caribbean and Central America Cluster Head and Panama Citi Country Officer. “Thi
WilsonHCG Recognized as a “Leader” in Contingent Workforce Solutions and MSP by NelsonHall20.9.2021 16:00:00 CEST | Press release
WilsonHCG has been identified as a “Leader” in NelsonHall’s 2021 NEAT Vendor Evaluation and Assessment Tool for Managed Service Program (MSP) and Contingent Workforce Services (CWS) providers. “Being ranked as a Leader for our contingent workforce services is a testament to listening to our clients’ needs and differentiating by providing a high-touch experience that’s often overlooked in this space. The team is committed to exceptional service and it shows,” said John Wilson, CEO, WilsonHCG. “Organizations are looking for a variety of talent solutions in this challenging market and we’re proud to offer contingent workforce services that give them access to the talent they need to succeed.” Nikki Edwards, Principal Research Analyst with NelsonHall’s HR Technology & Services practice, added, “WilsonHCG applies a high-touch and personalized approach to its range of next-generation contingent workforce solutions (with a broad range of service expertise and use of cutting-edge tech), enabli
EMGA Advises Landmark US$300M Debt Raise for BTG Pactual With DFC20.9.2021 16:00:00 CEST | Press release
Emerging Markets Global Advisory Limited (EMGA), the niche investment bank focused on emerging markets, announces today a landmark Senior Debt capital raise transaction that will allow BTG Pactual to expand its small and medium-sized enterprise (SME) activities in Brazil. The US$300 million debt facility was provided by DFC and the transaction is the largest Senior Debt facility ever advised by EMGA and follows on from a US$140 million transaction completed last year with DEG and Proparco, two European development institutions. The operation comes at a time when banks world-wide are exploring new cross-border funding options to further deliver on their support to businesses affected by the COVID-19 pandemic. Commenting on the transaction, BTG Pactual’s Caio Zanette said, “BTG Pactual is very pleased with the support of EMGA on pursuing this landmark transaction that will benefit our SME activities in Brazil. We continue to develop all our activities and the funding provided by DFC will
White Oak Buys Finacity in Flagship Acquisition20.9.2021 15:00:00 CEST | Press release
White Oak Global Advisors (“White Oak”) has completed the acquisition of Finacity Corporation (“Finacity”) a global leader in working capital and trade finance funding solutions to global businesses. Finacity originates, structures and places over USD$100 billion in trade finance receivables yearly with over 50 leading financial institutions in asset-backed security structures. Finacity has facilitated transactions for receivables denominated in 58 currencies with obligors in more than 175 countries making it the largest non-bank trade finance platform globally. The deal will see Adrian Katz remain as Finacity CEO and substantive equity holder, working closely with the leadership of White Oak Global Advisors. With this acquisition White Oak and its affiliates will have over 215 professionals focused on asset-based lending offering trade receivables securitization and a variety of ABL products including invoice discounting, factoring, trade finance, supply chain finance, lender finance
Zynga Debuts “Sneak Peek” for Upcoming Mobile FarmVille 3 Title20.9.2021 15:00:00 CEST | Press release
Zynga Inc. (Nasdaq: ZNGA): This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210920005007/en/ Zynga Debuts “Sneak Peek” for Upcoming Mobile FarmVille 3 Title (Graphic: Business Wire) WHAT: Today, Zynga Inc. (Nasdaq: ZNGA), a global leader in interactive entertainment and creator of the popular FarmVille franchise, unveiled a sneak peek video for its upcoming mobile title, FarmVille 3, that captures the fun and affectionate interactions among animals such as cuddly sheep and dancing cows as they excitedly wait to meet their new owners on the farm. Since it launched in 2009, the FarmVille franchise has continued to roll out fresh new ways for players to experience thegames, including FarmVille 2: Country Escape and FarmVille 2: Tropic Escape. One of the new gameplay features in FarmVille 3 will be the breeding and nurturing of adorable baby animals from more than 150 unique varieties, including horses, pigs, alpacas and arctic fo
UNAVETS Joins the Petabyte Consortium to Transform the Pet Care Experience for Doctors, Patients and Their Families20.9.2021 14:03:00 CEST | Press release
UNAVETS (“UNAVETS”), a European platform for veterinary centers with over 43 practices across Spain and Portugal, announced today their partnership with Petabyte Technology (“Petabyte”), a leading veterinary software company, to join the newly established Petabyte Consortium, which is focused on cleaning and standardizing data to improve veterinary practices across the world. Petabyte revolutionizes patient management for veterinary hospitals through its suite of software solutions, including Rhapsody, a cloud-based Practice Information Management System (PIMS); Petabyte Analytics, an enterprise-level analytics platform; and Boop, a mobile application simplifying the pet care experience for pet parents. With innovative features such as standardized data, comprehensive wellness plans, virtual check-in, on-the-go communications, and a built-in payment system, Petabyte enables doctors to deliver exceptional care to pets and their families. “Petabyte was founded with a mission to simplify
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom