KaNDy Therapeutics Announces Positive Clinical Data with Lead Candidate NT-814 for the Treatment of Symptoms of the Menopause
KaNDy Therapeutics, a UK clinical-stage biotech company, today announces positive data from the Phase Ib/IIa clinical trial with its lead non-hormonal drug candidate, NT-814, for the treatment of symptoms of the menopause.
Results from the trial provide compelling evidence that NT-814, a novel, once-daily, oral neurokinin-1,3 receptor antagonist, produces a rapid and profound reduction in debilitating symptoms of the menopause including vasomotor symptoms (VMS), also known as HF, and night time awakenings.
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 will begin later this year.
The Phase Ib/IIa RELENT-1 study was a randomised, double-blind, placebo-controlled study conducted at three clinical pharmacology units (CPUs) in the US. Seventy-six women aged 41 to 64 years experiencing 7-20 moderate or severe hot flashes/flushes (HF) per week were recruited into the study and randomized to receive one of four escalating doses of NT-814 or placebo.
Treatment with NT-814 once daily for two weeks at the most effective dose evaluated, resulted in rapid and highly 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 well tolerated with no safety concerns across the dose range including routine safety labs, liver function tests, ECGs and vital signs.
Professor Richard Anderson, Elsie Inglis Professor of Clinical Reproductive Science, University of Edinburgh, and a scientific and clinical advisor to KaNDY Therapeutics, said: ““These are very promising results which suggest that NT-814, a novel once daily treatment taken orally, may offer women with debilitating symptoms of the menopause, a real alternative to hormone replacement therapy (HRT). In contrast to HRT, which can take weeks or months to be fully effective, both hot flashes and night-time awakenings responded rapidly and with big changes with NT-814.”
In addition, KaNDy Therapeutics announces it will be attending the 16th World congress on Menopause taking place in Vancouver, Canada, from 6-9 June 2018. To arrange a meeting with Dr Mary Kerr, Managing Director of KaNDy Therapeutics at the congress, please contact email@example.com
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 week 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 in menopausal women due to the absence of oestrogen, 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.
Mary Kerr, Managing Director of KaNDy Therapeutics
Tel: +44 1438 906960
Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
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
Thales and Gemalto Announce Regulatory Clearance from the Minister of Innovation in Canada14.8.2018 16:00 | Pressemelding
Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto today announce that they have received foreign investment Regulatory Clearance in Canada. Together with the anti-trust clearance obtained in China and Israel, and clearance relating to foreign investments in Australia, Thales and Gemalto have obtained 4 of the required 14 Regulatory Clearances. Thales and Gemalto continue to work constructively with the competent antitrust authorities to obtain the remaining
BCW Acquires Creative Powerhouse HZ, Significantly Expanding Expertise in Integrated Communications14.8.2018 14:26 | Pressemelding
BCW (Burson Cohn & Wolfe), a leading global communications agency and a WPP company, today announced it has acquired HZ, one of the largest independent, digitally driven, integrated creative agencies in the U.S. Headquartered in Rockville, Maryland with offices in Baltimore, Los Angeles, New York and Washington, D.C., the acquisition will add the capability of HZ’s nearly 200 creative and digital professionals to BCW’s deep expertise in integrated communications across all industry sectors. HZ’s wide-ranging offerings include a full spectrum of multichannel digital design and development, mobile activation, social media, brand and identity creation, content, film and video production, search marketing (SEO/SEM), data and analytics as well as integrated media solutions. HZ’s broad client base spans the consumer, hospitality, food & beverage, education, B2B, real estate, sports & entertainment, healthcare and technology industries and counts Hilton Worldwide, Salesforce.org and Tishman S
Andersen Global Initiates Expansion in Mozambique14.8.2018 13:30 | Pressemelding
Andersen Global continues expansion in Africa with Isalcio Mahanjane e Associados, a law firm headquartered in Maputo, Mozambique. The collaboration with Isalcio Mahanjane e Associados signifies Andersen’s growth in the African region, as Mozambique provides strategic coverage in Southeast Africa and is the sixth country to collaborate or join in Africa in the past 14 months. Led by Managing Partner Isalcio Mahanjane, the firm includes 10 professionals and specializes in providing quality services in all branches of law for corporations and individuals. These services include commercial and corporate law, banking and financial law, labor law, real estate management, oil and gas, mines, and law and administrative litigation. “Mozambique will be a key point of connectivity with our practice in Portugal as we continue to focus on best-in-class solutions in Africa,” commented Global Chairman and Andersen Tax LLC CEO, Mark Vorsatz. “Isalcio and his team are passionate about their practice a
Gyeonggi Province of Korea Launches Beyond the Dream Global VLOG Contest14.8.2018 12:00 | Pressemelding
Gyeonggi Provincial Government and Gyeonggi Tourism Organization (GTO) are hosting an international video contest called “Beyond the Dream VLOG Contest 2018.” Video submissions will be accepted until August 26, 2018 (Korean Standard Time). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180814005240/en/ Gyeonggi Provincial Government and Gyeonggi Tourism Organization (GTO) are hosting an international video contest called "Beyond the Dream VLOG Contest 2018." Video submissions will be accepted until August 26, 2018 (Korean Standard Time). The goal of the "Beyond the Dream VLOG Contest 2018" is to raise global awareness of Gyeonggi Province as an attractive travel destination and to select a Gyeonggi-do tourism ambassador who will show the world the charms of the province. Four final-winning teams will win a 10 day trip to Gyeonggi Province. USD 10,000 travel expenses for airline tickets and other travel expenses will be provi
CTS Engines Inducts First PW2000 Engine14.8.2018 12:00 | Pressemelding
CTS Engines, the global leader for mature engine maintenance within the Aerospace & Defense industry, announced today that it had inducted the first PW2000 engine into its engine overhaul facility in Ft. Lauderdale, FL. Along with the CF6-80C2, CF6-80A, and CF6-50C2, the PW2000 represents the fourth engine model type serviced by CTS. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180814005021/en/ PW2000 Engine. (Photo: Business Wire) “The profile of the PW2000 engine—which will continue to operate on B757s in cargo configuration and on C-17 Globemaster military transport aircraft for years to come—is an ideal fit for the CTS product line,” said Vesa Paukkeri, CTS’s President and Chief Operating Officer. “CTS is the go-to independent jet engine MRO for sunset engines operating in cargo and military transport configurations. We look forward to servicing this engine through the remainder of its time on wing over the next 30+ ye
BOC Group has just released ADONIS:CE – A Milestone in Free Cloud BPM Tools!14.8.2018 11:00 | Pressemelding
BOC Group announces the release of brand new ADONIS:Community Edition, now available in the cloud for free. Today, BOC Group launched the next in line descendent of its worldwide-known free Business Process Management tool, ADONIS:CE. This launch is more than just a product update: it marks the ADONIS:Community Edition's shift to the battle-tested web-platform and its transition to the cloud as SaaS. Based on the latest version of BPM suite's commercial edition ADONIS NP 5.5, ADONIS:CE makes a grand entrance with its fresh design, state-of-the-art functionality and exceptional user experience. Tobias Rausch, ADONIS product manager elaborates: “We believe in spreading BPM to all regions, as well as teams and companies of all sizes, by providing a free-of-charge tool that helps businesses improve their process game. That is why we have designed a freely available BPM tool with such an outstanding and rich feature-set.” In addition to the capabilities mentioned above, ADONIS:CE comes with