KaNDy Therapeutics presents new compelling data with lead candidate NT-814 at The North American Menopause Society 2018 Annual Meeting
KaNDy Therapeutics, a UK clinical-stage biotech company, announces the presentation of new clinical data from the Phase Ib/IIa proof of concept clinical trial with its lead non-hormonal drug candidate, NT-814, at The North American Menopause Society 2018 Annual Meeting taking place from 3-6 October 2018 in San Diego, US.
Data from the Phase Ib/IIa RELENT-1 study, presented by Dr Steve Pawsey, Chief Medical Officer at KaNDy Therapeutics, demonstrate compelling evidence that NT-814, a novel, once-daily, oral neurokinin-1,3 receptor antagonist, being developed to provide a safe and effective alternative to hormone replacement therapy (HRT), produces a rapid and profound reduction in debilitating symptoms of the menopause including vasomotor symptoms (VMS), also known as hot flush or flash (HF), and night time awakenings.
The effects of treatment with NT-814 were immediate in onset, being both statistically significant and clinically relevant as soon as the first day of treatment. In contrast, studies with HRT have shown onset is within weeks or months.
The Phase Ib/IIa data also demonstrated that treatment with NT-814, taken once daily for two weeks at the most effective dose evaluated, resulted in rapid and significant reductions in:
- the frequency of HF, with a reduction of 62% from baseline in the number of moderate and severe HF vs 24% for placebo in Week 1 (p<0.0014) and an 84% reduction from baseline vs 37% for placebo in week 2 (p<0.0002)
- the severity of HF, with a reduction of 23% from baseline in average HF severity vs 9% for placebo in week 1 (p<0.015) and a 50% reduction from baseline vs 16% for placebo in Week 2 (p<0.0004)
- the number of night time awakenings, with a reduction of 58% from baseline vs 17% for placebo in Week 1 (p< 0.0022) and an 81% reduction from baseline vs 32% for placebo in Week 2 (p< 0.0005).
NT-814 was found to be well-tolerated and no safety concerns were identified in the study.
Commenting on the data, Dr Steve Pawsey, Chief Medical Officer at KaNDy Therapeutics said: “These data presented today provide very compelling evidence to support the use of NT-814 to treat bothersome symptoms of the menopause. The fact that the effects of treatment are seen from the first day is extremely promising and positions NT-814 as a real alternative to HRT which can take weeks or months to be fully effective. We are looking forward to progressing this candidate through clinical development, in order to make this treatment commercially available as soon as possible.”
Dr Hadine Joffe, Paula A. Johnson Associate Professor of Psychiatry in the Field of Women’s Health, Harvard Medical School, Executive Director of the Connors Center for Women’s Health, Brigham and Women's Hospital, and Scientific and Clinical Advisor to KaNDy Therapeutics added: “The results generated thus far are indeed promising. HRT is effective and has a number of safety concerns and is slow in onset, so there is a real need for a safe, non-hormonal treatment option which acts quickly to relieve symptoms. This study has shown that NT-814 not only results in rapid and significant reductions in both hot flashes and night-time awakenings, but also that the effects of treatment are immediate. I believe NT-814 could be a potentially breakthrough non-hormonal option for the millions of women who suffer with debilitating symptoms related to menopause.”
Based on these results, KaNDy Therapeutics intends to advance NT-814 into a fully powered Phase IIb definitive dose-ranging study in patients suffering from debilitating symptoms of the menopause. The Phase IIb trial is expected to begin later this year.
The full abstract can be viewed on The NAMS website: https://www.menopause.org/annual-meetings/2018-meeting/meeting-abstracts
About the RELENT-1 Study: The Phase Ib/IIa RELENT-1 study was a randomised, double-blind, placebo-controlled study conducted at three clinical pharmacology units (CPU) in the US. Seventy-six women aged 41 to 64 years experiencing 7-20 moderate or severe HFs per day were recruited into the study and randomized to receive one of four escalating doses of NT-814 or placebo in four cohorts. Study drug was taken once daily in the morning for 14 days, the first seven of which were resident in the CPU. Subjects completed diaries twice daily for the two weeks before and throughout treatment and underwent routine safety assessments periodically throughout the trial. Further information on the study design can be found on www.clinicaltrials.gov and full results of the study will be published at scientific congresses and in peer-reviewed journals over the coming months.
NT-814 is an orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses VMS by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that, because of the absence of oestrogen in menopausal women, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of HF.
KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal VMS, are debilitating for women often over many years and associated with significant healthcare and economic costs.
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
IFF Recognized by SAM’s 2019 “Industry Mover” Sustainability Award15.2.2019 21:15:00 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), was recognized for its sustainability efforts with the 2019 “Industry Mover” award from SAM, a subsidiary of RobecoSAM which specializes in providing environmental, social and governance (ESG) data, benchmarks and ratings. The recognition acknowledges the Company’s top-scoring performance in economic, social and environmental categories. “We are thrilled to receive this award from SAM,” said Andreas Fibig, IFF Chairman & CEO. “Our sustainability efforts are not only a key enabler of our overall strategy, but also a true passion here at IFF -- and we place it at the forefront of everything we do. It is deeply gratifying to have our work and our people recognized for doing the right thing for the planet.” SAM’s 2019 scoring is based on its 2018 Corporate Sustainability Assessment. Using a weighted methodology, SAM evaluates companies for criteria such as: codes of business conduct, ope
SFL: strong financial position and results in 2018, consolidating the Group’s position as a prime player15.2.2019 18:01:00 | Pressemelding
Regulatory News: The financial statements for the year ended 31 December 2018 were approved by the Board of Directors of Société Foncière Lyonnaise (Paris:FLY) on 15 February 2019 at a meeting chaired by Juan José Brugera. 2018 business indicators were very robust, with further underlying growth in rental income and historically high EPRA earnings. The portfolio's appraisal value and the Company's net asset value also continued to grow, attesting to SFL’s excellent positioning. The auditors have completed their audit of the annual financial information and are in the process of issuing their report. Consolidated data (€ millions) 2018 2017 Change Rental income 193.5 195.8 -1.2% Adjusted operating profit* 162.1 164.1 -1.2% Attributable net profit 351.6 685.3 - EPRA earnings 106.7 102.4 +4.1% * Operating profit before disposal gains and losses and fair value adjustments 31/12/2018 31/12/2017 Change Attributable equity 4,010 3,763 +6.6% Consolidated portfolio value excluding transfer cost
5 Happening Cultural Destinations to Visit in 201915.2.2019 10:11:00 | Pressemelding
Hong Kong There’s never really a sleepy year to visit Hong Kong, but 2019 is particularly ripe for visitors. Spearheaded by the dynamic entrepreneur Adrian Cheng of K11 and New World Development, the rejuvenation of Tsim Sha Tsui harbourfront is just the starting point. The city’s iconic harbourside walkway, Avenue of Stars, has just received a much-awaited makeover that’s the brainchild of Cheng and visually conceived by James Corner, the landscape architect responsible for the High Line in New York. It sees the addition of design-driven rest areas, kiosks featuring homegrown brands, hand prints from Asian film stars and interactive digital elements. Featuring Hong Kong’s first wave energy demonstrator that produces electricity for the Avenue, the place is turned into one of the most sustainable promenades in Hong Kong. This is just one part of Cheng and his company’s grander urban revitalisation plan, Victoria Dockside, a new art and design district which will fully open in the third
ISAE-SUPAERO Launches a New MOOC about Flight Mechanics15.2.2019 09:36:00 | Pressemelding
"ABC of Flight Mechanics: How Do Planes Fly?": a MOOC dedicated to flight mechanics. The notion of flight often defies our human terrestrial instincts. How does an airplane fly? How can a pilot maintain control? How high in the sky can an aircraft climb? How does a fighter pilot fly while spinning? This online course (available in English) will cover many topics, such as atmospheric physics and Newton's laws applied to aircraft, as well as propulsion forces and longitudinal stability the question of traction. The MOOC "ABC of Flight Mechanics" is aimed at general public with a specific level of scientific knowledge. Nevertheless, various levels of learning are available, thus it allows all students to take the course without needing to plenty understand the mathematical principles. Undergraduate students in aerospace engineering, trainees as well as novice and experienced pilots, journalists and professionals in the aeronautics domain (business, engineering, marketing, communications,
REPLY: Red Reply Wins the Oracle “Partner of the Year Autonomous” Award15.2.2019 09:30:00 | Pressemelding
Red Reply, the Reply group company that specialises in the Oracle Cloud IaaS and PaaS platform has been named as Oracle “Partner of the Year: Autonomous.” The award recognises Red Reply for its work as an Oracle Cloud Managed Service Provider Partner in developing highly innovative projects using the Oracle Autonomous Database technology. Red Reply has launched a project aimed at re-engineering the Policy Enterprise DataWarehouse of Verti Assicurazioni, company operating in the online insurance sector, using the Oracle Cloud Autonomous DataWarehouse service. The Autonomous DataWarehouse is a cloud-based database that uses machine learning to eliminate manual labour in operations such as tuning, security, backups, updates and other routine activities. This selected Oracle solution is the only one of its kind capable of addressing aspects such as security, performance and high availability of data, using automatic update and tuning mechanisms, while maximising the protection of data in l
Posiflex showcases new Interactive Self-Service Kiosks and IoT Retail Product Innovations at EuroCIS 201915.2.2019 08:00:00 | Pressemelding
The Posiflex Group — a synergy of world-leading POS, kiosk, and industrial computing technologies — will introduce its full product portfolio and latest innovations at EuroCIS, the leading trade fair for retail technology, from February 19th – 21st in Düsseldorf. With a product strategy focus on serviced IoT, the Posiflex Group will be displaying smart and connected retail solutions with fully-integrated middleware, RMS (Remote Monitoring System) and hardware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190215005008/en/ Posiflex at EuroCIS Hall 9 / C42 (Graphic: Business Wire) “I am excited to introduce the Posiflex Group portfolio to the European market,” says Hans Peter Nüdling, the newly appointed Chief Strategy Officer for the Posiflex Group. “The Posiflex Group references the collective brands of the corporation, including Posiflex, Portwell and KIOSK Information Systems (KIOSK) – all under one corporate umbrella. As