Business Wire

Novaremed Expands its Pipeline of Non-opioid Treatment Candidates for Chronic Pain Indications Through Acquisition of Metys Pharmaceuticals

Share

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.

About Novaremed

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.

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

# # #

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Isaac Kobrin, M.D., Executive Chairman of the Board
isaac.kobrin@novaremed.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Pencil Lab Inks Debut in ADIHEX 202125.9.2021 13:04:00 EEST | Press release

The 18th edition of the Abu Dhabi International Hunting and Equestrian Exhibition (ADIHEX) on September 27 - October 3 marks an opportune platform for Pencil Lab Design Studio’s first major participation in the massive event, the largest of its kind in the Middle East and Africa. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210925005016/en/ Pencil Lab Inks Debut in ADIHEX 2021 (Photo: AETOSWire) Featuring more than 800 brands and companies, the event is held under the theme of ‘Sustainability and Heritage… A Reborn Aspiration’, highlighting heritage, culture and authentic sports and their strong relation with Arab history. As part of its inaugural participation in a major exhibition as a company, Pencil Lab, a UAE initiative, will showcase their artworks with three large oil paintings by Pencil Lab’s citizen artist, to highlight the strong connection of arts, like painting and photography, to Arab history and civilization.

DXC Technology Completes Refinancing Actions24.9.2021 23:30:00 EEST | Press release

DXC Technology Company (NYSE: DXC) (“DXC”) today announced the completion of its refinancing. DXC previously completed the offering of €1.35 billion Senior Notes priced on September 2, 2021 and $1.35 billion Senior Notes priced on September 7, 2021. DXC completed redemption of $2.5 billion principal of (i) EUR term loan in the amount of €400 million due FY23 and FY24, (ii) $500 million 4.25% Senior notes due FY25, (iii) £250 million 2.75% Senior notes due FY25, (iv) $467 million 4.125% Senior notes due FY26, (v) $500 million 4.75% Senior notes due FY28, and (vi) $234 million Senior notes due FY30. The applicable make whole premium for these redemptions was $300 million and accrued and unpaid interest was $40 million. Ken Sharp, Chief Financial Officer, DXC commented: “Our opportunistic debt refinancing of $2.5 billion of our high coupon debt further solidifies our financial foundation by extending our debt maturities, lowering our maturity towers and reducing our ongoing interest expen

Schlumberger Announces Third-Quarter 2021 Results Conference Call24.9.2021 17:00:00 EEST | Press release

Schlumberger Limited (NYSE:SLB) will hold a conference call on October 22, 2021 to discuss the results for the third quarter ending September 30, 2021. The conference call is scheduled to begin at 9:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (844) 721-7241 within North America or +1 (409) 207-6955 outside of North America approximately 10 minutes prior to the start of the call and the access code is 8858313. A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until November 22, 2021, and can be accessed by dialing +1 (866) 207-1041 within North America or +1 (402

Tradeweb Successfully Completes its First Southbound Bond Connect Transactions24.9.2021 15:07:00 EEST | Press release

Tradeweb Markets Inc. (Nasdaq: TW), a leading global operator of electronic marketplaces for rates, credit, equities and money markets, today announced it has completed its first Southbound Bond Connect transactions via the trading link between Tradeweb and China Foreign Exchange Trade System (CFETS). “Southbound Bond Connect is the latest evolutionary step for China’s financial market, providing domestic investors with more flexibility and choice when trading offshore bonds,” said Lee Olesky, CEO of Tradeweb Markets. “Together with CFETS, our goal is to better meet onshore investors’ demand for streamlined access to global investment. We will continue to focus on further enhancing the trading link by deploying new innovative trading functionality, just as we did with the Northbound leg of Bond Connect.” Southbound Bond Connect facilitates fixed income portfolio diversification for institutional investors in China. Tradeweb collaborates closely with CFETS to create a uniform trading ex

H.I.G. Capital Acquires Aspire Pharma24.9.2021 15:05:00 EEST | Press release

H.I.G. Capital, LLC (“H.I.G.”), a leading global alternative investment firm with $45 billion of equity capital under management, is pleased to announce that one of its affiliates has acquired Aspire Pharma Limited (“Aspire” or the “Company”), a leading UK provider of niche generic and branded specialty pharmaceuticals, alongside its founder Graham Fraser-Pye. The financial terms of the transaction have not been disclosed. Aspire licenses and develops niche generic and specialty pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets that are often underserved. The business holds leadership positions in urology, ophthalmology, CNS and dermatology, with a highly diversified portfolio of more than 250 products across multiple categories, including branded specialty products and unbranded niche generics. H.I.G., together with the management team, aims to continue Aspire’s strong track record of organic growth and

Swappable Announces Partnership with Esports T1's Dota 2 Team24.9.2021 14:34:00 EEST | Press release

Swappable, an NFT (Non-Fungible Token) interface for high-profile and exclusive digital collectibles, has announced its partnership with T1's Dota 2 team, the popular esports team for the upcoming International 10 - Dota 2 World Championship in Bucharest, Romania. T1 is not just an esports team but a pop culture phenomenon with millions of fans worldwide. The team embodies a blend of lifestyle, creativity and attitude, fresh from the source of Seoul & LA. As part of the collaboration, T1 will auction their first-ever NFTs (digital collectibles) on Swappable for T1’s Genesis Collection. With the first auction starting Friday September 24th, T1 will release a series of NFTs each possessing utility features such as special access to T1's Dota 2 team players and more. Visit Swappable for more information. “We are excited to partner with a leading organization in the esports industry. It is also a chance for T1 fans to pick the very first digital collectibles ever created by this legendary

SAB Biotherapeutics Announces SAB-185 Receives Positive DSMB Review and Advances to Phase 3 in NIH-Sponsored ACTIV-2 Trial for Treatment of COVID-1924.9.2021 14:00:00 EEST | Press release

SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced that an independent Data Safety Monitoring Board (DSMB) has completed its prespecified interim analysis data review of the safety and efficacy of SAB-185 in the Phase 2 portion of the ACTIV-2 trial and has recommended advancement to Phase 3. SAB-185 is a fully-human, specifically-targeted, broadly-neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with mild to moderate COVID-19. It is being assessed in the ACTIV-2 trial funded and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) in collaboration with the AIDS Clinical Trials Group. SAB-185 is advancing to the Phase 3 trial based on meeting pre-defined graduation crite

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