(22423 NIRVANA) A randomized, parallel-group treatment, Phase 2, double-blind pilot study to investigate the efficacy and safety of elinzanetant compared with placebo for treatment of sleep disturbances associated with menopause - 22423

Start Date26 Mar 2024

Sponsor / Collaborator

Bayer Consumer Care AG

[+1]

NCT06219902 / CompletedPhase 1

A Randomized, Double-blind, Placebo- and Active-controlled, 4-period, Crossover Study to Investigate Effects of Elinzanetant on Simulated Driving Performance and Cognitive Function in Healthy Women

Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes.
Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Such symptoms are called VMS and are caused by changes in sex hormone levels.
The study treatment, elinzanetant, is being tested for the treatment of VMS in both men and women. It works by blocking the activity of a substance called neurokinin, which is thought to play a role in starting hot flashes.
Elinzanetant may cause lasting effects like sleepiness and tiredness. Such effects may make driving unsafe.
The main purpose of this study is to learn how elinzanetant affects the ability to drive the next day in healthy women.
For this, researchers will study participants' ability to keep a stable position within their lane while driving on a straight road on a computer-based driving test (also known as a driving simulator).
In this study, participants will take 2 different doses of elinzanetant, another drug called zopiclone, and matching placebos to these drugs.
Zopiclone helps treat sleeping problems. A placebo looks like a study drug but does not have any medicine in it.
Participants will take elinzanetant, zopiclone, and their matching placebos by mouth.
This study will have 4 treatment periods with each period lasting 6 days. In each period, participants will receive one of the following treatments in an order assigned to them randomly (by chance):
dose A of elinzanetant and a zopiclone placebo
dose B of elinzanetant and a zopiclone placebo
zopiclone 7.5 milligrams (mg) and elinzanetant placebo
elinzanetant placebo and zopiclone placebo
Each participant will be in the study for around 15 weeks with up to 6 visits to the study site.
Participants will visit the study site:
once before the treatment starts, so the study doctors and their team can check on their health and confirm if the participant can join the study
once in each of the 4 treatment periods for a 6-day stay at the study site with a gap of 14 days between each period. During each stay, they will take the assigned treatment from Days 1 to 5 and the driving test on Days 2 and 6
once, 2 to 3 days after their last treatment so the study doctors and their team can check on their health
During the study, the doctors and their study team will:
check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
check the participants' ability to drive and their brain function and level of sleepiness using different tests including a driving simulator test
check the level of the study drugs in participants' blood
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment or not.

Start Date08 Jan 2024

Sponsor / Collaborator

Bayer AG

NCT06112756 / Active, not recruitingPhase 2

A Randomized, Parallel-group Treatment, Phase 2, Double-blind Pilot Study to Investigate the Efficacy and Safety of Elinzanetant Compared With Placebo for Treatment of Sleep Disturbances Associated With Menopause.

Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause.
Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life.
The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances.
The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo.
For this, the researchers will analyze
* change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment
* change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment
* change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment.
The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks.
Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned.
During the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check vital signs
* do sleep tests
* use an electronic hand-held device to record sleep quality and hot flashes at home
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Start Date08 Nov 2023

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Elinzanetant

100 Translational Medicine associated with Elinzanetant

100 Patents (Medical) associated with Elinzanetant

Literatures (Medical) associated with Elinzanetant

18 Sep 2024·CPT-Pharmacometrics & Systems Pharmacology

Population pharmacokinetic-pharmacodynamic model of elinzanetant based on integrated clinical phase I and II data.

Article

Author: Joseph, Shiju ; Willmann, Stefan ; Schultze-Mosgau, Marcus-Hillert ; Frechen, Sebastian ; Zhang, Yang ; Austin, Rupert ; Lloyd, Adam ; Schneider, Annika R P ; Solms, Alexander

Elinzanetant is a potent and selective dual neurokin-1 (NK-1) and -3 (NK-3) receptor antagonist that is currently developed for the treatment of women with moderate-to-severe vasomotor symptoms (VMS) associated with menopause. Here, we report the development of a population pharmacokinetic (popPK) model for elinzanetant and its principal metabolites based on an integrated dataset from 366 subjects (including 197 women with VMS) collected in 10 phase I or II studies. The pharmacokinetics of elinzanetant and its metabolites could be well described by the popPK model. Within the investigated dose range of 40-160 mg, the oral bioavailability of elinzanetant was dose independent and estimated to be 36.7%. The clearance of elinzanetant was estimated to be 7.26 L/h and the central and peripheral distribution volume were 23.7 and 168 L. No intrinsic or extrinsic influencing factors have been identified in the investigated population other than the effect of a high-fat breakfast on the oral absorption of elinzanetant. The popPK model was then coupled to a pharmacodynamic model to predict occupancies of the NK-1 and NK-3 receptors. After repeated once-daily administration of the anticipated therapeutic dose of 120 mg elinzanetant, the model-predicted median receptor occupancies are >99% for NK-1 and >94.8% for NK-3 during day and night-time, indicating sustained and near-complete inhibition of both target receptors during the dosing interval.

01 Jun 2024·Menopause (New York, N.Y.)

Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause

Article

Author: Mao, Guangping ; Atanackovic, Gordana ; Mellinger, Uwe ; Morrison, Marina ; Pinkerton, JoAnn V. ; Caetano, Cecilia ; Holz, Cornelia ; Haberland, Claudia ; Schaefers, Matthias ; Parke, Susanne ; Seitz, Christian ; Nisius, Sven ; Haseli Mashhadi, Nazanin ; Panay, Nick ; Simon, James ; Zuurman, Lineke

Abstract:

Objective:

Elinzanetant is a selective neurokinin-1,3 receptor antagonist in development for the treatment of vasomotor symptoms (VMS) associated with menopause. The pivotal, double-blind, randomized, placebo-controlled phase 3 studies Overall Assessment of efficacy and Safety of elinzanetant In patients with vasomotor Symptoms (OASIS) 1 and 2 will assess the efficacy and safety of elinzanetant in women with VMS.

Methods:

The OASIS 1 and 2 pivotal studies are designed in accordance with regulatory guidance. Postmenopausal women with moderate/severe VMS are randomized to receive 120 mg elinzanetant or placebo once daily for 12 weeks, followed by a 14-week active treatment extension. Primary endpoints are the mean change in frequency and severity of moderate/severe VMS from baseline to weeks 4 and 12. Key secondary endpoints will assess the onset of action and effects on sleep disturbance and menopause-related quality of life. Primary and key secondary endpoints will be analyzed using a mixed model with repeated measures. Feedback from postmenopausal women with VMS was used during protocol development.

Results:

Women confirmed the relevance of endpoints that assess the impact of VMS, sleep disturbance, and mood changes, and the need for new nonhormone treatments. Educational materials around study design, conduct and expected assessments and procedures were developed based on questions and concerns raised by women.

Conclusions:

The OASIS 1 and 2 pivotal phase 3 studies will enable assessment of the efficacy and safety of elinzanetant as a treatment for VMS, together with its effect on sleep disturbances, depressive symptoms, and menopause-related quality of life. Feedback from postmenopausal women with VMS was used to maximize patient centricity in the trials.

02 May 2024·EXPERT OPINION ON PHARMACOTHERAPY

Elinzanetant, a new combined neurokinin-1/-3 receptor antagonist for the treatment of postmenopausal vasomotor symptoms

Review

Author: Hager, Marlene ; Ott, Johannes ; Fitz, Victoria ; Goldstein, Tal

INTRODUCTION:

In many postmenopausal women, quality of life is decreased due to vasomotor symptoms. Efficient and well-tolerated non-hormonal treatment options are needed.

AREAS COVERED:

The present review summarizes what is known about the etiology of postmenopausal vasomotor symptoms as a rationale for the mechanism of action of Elinzanetant, a new neurokinin (NK)-1/-3 receptor antagonist, as well as its efficacy and side effect profile.

EXPERT OPINION:

Elinzanetant likely exerts an antagonistic effect on the NK-3 receptor in the preoptic thermoregulatory zone, but also an additional antagonistic effect on the NK-1 receptor possibly leading to a reduction in vasodilatation and heat-sensing neuro-activity. Elinzanetant's reported peak drug concentrations are reached within one hour and the terminal elimination half-life is approximately 15 hours. Two phase IIb clinical trials evaluated the safety profile and efficacy of several doses. There were no serious adverse events, which also included a lack of evidence of drug-related hepatotoxicity. Overall, Elinzanetant seems to be well-tolerated. In the SWITCH-1 study, the 120 mg/day and 160 mg/day regimen showed good efficacy for the treatment of vasomotor symptoms and led to significant improvements in quality of life. Thus, 120 mg oral Elinzanetant/day was used in phase III trials, whose results have not yet been published.

News (Medical) associated with Elinzanetant

16 Oct 2024

·www.pharmaceutical-technology.com

Synedgen partners with BARDA for MIIST305 development

GI-ARS is a significant radiation toxicity that can result in sepsis and lead to death. Credit: Jo Panuwat D/Shutterstock. Synedgen has announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to develop its lead therapeutic, MIIST305, targeting gastrointestinal acute radiation syndrome (GI-ARS). GI-ARS is a significant radiation toxicity that can result in sepsis and lead to death, especially when patients are exposed to high levels of radiation from accidental or malicious sources. The deal, valued at up to $119m over six years, aims to fill a crucial gap in medical countermeasures for radiation exposure. Synedgen’s collaboration with BARDA begins with $17m dedicated to proof-of-concept studies in two animal models. The successful completion of these studies could lead to further development of MIIST305 through US Food and Drug Administration (FDA) approval. See Also: Bayer applies for EU approval of menopause drug elinzanetant ENHERTU gains conditional approval in China to treat NSCLC This partnership not only furthers the drug’s development but also contributes to the optimisation of a new nonclinical model for GI-ARS that could gain FDA acceptance. Synedgen president and CEO Shenda Baker stated: “We are delighted to be partnering with BARDA to develop MIIST305 as a therapeutic to address GIARS. “No currently available FDA-approved therapeutic exists to protect major gastrointestinal organs against acute exposure to ionising radiation. Importantly, this programme leverages Synedgen’s MIIST305 programme to address gastrointestinal inflammation and damage from radiation, chemical or physiological sources, thus potentially meeting this unmet need.” Currently, there are four FDA-approved products to treat haematopoietic acute radiation syndrome (H-ARS), but no approved treatments for GI-ARS. The partnership between Synedgen and BARDA addresses this gap, enhancing national defence readiness against radiation-related injuries. Synedgen’s drug design platform, known as multivalent innate immune signalling target (MIIST), has been instrumental in the development of MIIST305. This non-systemic therapeutic works by modulating immune responses and targeting the gastrointestinal cell surface to repair and restore the gut mucosal barrier, mitigating the effects of radiation exposure. Synedgen has also established a Phase I-ready programme for MIIST305 for ulcerative colitis treatment.

Radiation TherapyPhase 1IND

16 Oct 2024

·www.pharmaceutical-technology.com

bit.bio defends European patent for ‘novel’ opti-ox technology

The EPO ruling affirms bit.bio’s European patent for opti-ox, its proprietary stem cell engineering technology. Credit: Yavdat/ Shutterstock bit.bio has successfully defended the European patent for its opti-ox cell programming technology. After a hearing held on 25 September 2024, the European Patent Office (EPO) affirmed bit.bio’s claim against an anonymous opposition filed on 5 January 2023. The company’s proprietary method for pluripotent stem cell (PSC) programming, opti-ox, was deemed a sufficiently novel and inventive step of innovation (EP3545079). The European patent joins those secured in three other markets, the US (11697823), China (CN110249045), and South Korea (KR102500322), as bit.bio awaits rulings on similar applications in Australia and Japan. “opti-ox has the potential to revolutionise research and cell therapies on a global scale,” says Thomas Südhof, Nobel Laureate, adding that he believes the approach, “is currently the only way to ensure safe, consistent, and scalable forward programming of PSCs”. The technology uses bit.bio’s dual genomic safe harbour approach to control gene expression and transform induced PSCs into several cell types. According to Mark Kotter, bit.bio CEO, the method relies on the company’s, “unique ability to conduct multiplexed screens of over 2,300 transcription factors, combined with AI platforms that rapidly predict and read out transcription factor combinations that define cell types”. After forming out of the University of Cambridge in 2016, bit.bio has raised $41.6m and $103m in Series A and Series B financing, respectively. The company claims its approach could prove integral to research, drug discovery, and cell therapies. Its lead candidate, bbHEP01 (txHepatocytes), is currently in preclinical testing to treat acute liver diseases. See Also: Bayer applies for EU approval of menopause drug elinzanetant ENHERTU gains conditional approval in China to treat NSCLC bit.bio has also fostered several partnerships to leverage its platform. In August 2023, the company collaborated with BlueRock Therapeutics to research T cell therapies; the jointly-developed txTreg cells are in preclinical study for autoimmune disorders. In April 2024 it partnered with Bi/ond to study Duchenne muscular dystrophy (DMD), and later in March collaborated with the Michael J. Fox Foundation to advance research and drug discovery for Parkinson’s disease. Hermann Hauser, bit.bio board chairman, expressed the company’s ambition to establish itself in the cell therapy market, with emphasis on the commercial scalability of their technology. As per a March 2024 report from GlobalData, the global cell and gene therapy market is projected to reach $66bn by 2029; $12.2bn of this is estimated to derive from central nervous system disorders such as Alzheimer’s and Parkinson’s disease, indications on which bit.bio is focussed. GlobalData is the parent company of Pharmaceutical Technology . Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Optimise your cell therapy process: a guide to cell thawing Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Cell Therapy

15 Oct 2024

·www.pharmaceutical-technology.com

Transgene’s stock drops after Phase II cancer jab trial misses primary endpoint

Transgene’s Phase II trial of viral-based vaccine TG4001 failed to meet its primary endpoint. Credit: Kitsawet Saethao via Shutterstock. Transgene ’s stock has dropped after a Phase II trial of its therapeutic vaccine candidate TG4001 (tipapkinogene sovacivec) failed to meet its primary endpoint of improvement in progression-free survival (PFS) in solid tumours. Transgene’s share price fell 18.8% from €1.17 at close on 11 October to a low of €0.95 on Monday morning (14 October) after the announcement, settling at around €1 per share. The trial (NCT03260023) aimed to assess the impact of TG4001 in combination with Merck KgaA’s Bavencio (avelumab), a PD-L1 checkpoint inhibitor, in 150 patients with recurrent or metastatic HPV16-positive cervical and anogenital cancers who were either treatment-naïve or had one prior systemic chemotherapy, but no earlier immunotherapy. The addition of TG4001 did not produce statistically significant improvements in PFS across the study population, however, Transgene said it remains optimistic. In a subgroup of patients with cervical cancer – comprising about 54% of the trial population – the data suggested a potential trend towards improved PFS. The French biotech is planning further analysis, including examining the data by PD-L1 status, before deciding on the next steps for the candidate’s development. PD-L1 status refers to the level of expression of the PD-L1 protein on tumour cells, which can influence how well a patient’s cancer responds to Bavencio. See Also: Bayer applies for EU approval of menopause drug elinzanetant ENHERTU gains conditional approval in China to treat NSCLC TG4001, a viral-based vaccine, works by inducing an immune response against cells expressing the HPV16 E6 and E7 antigens, aided by the inclusion of human IL-2 to strengthen this immune reaction. In the announcement accompanying the data, Transgene’s CEO Alessandro Riva said: “Failure to meet the primary objective in our Phase II study with TG4001 is disappointing. Nevertheless, we are encouraged by the positive efficacy trend in favour of the combination regimen in cervical cancer patients.” Transgene said that it remains focused on its lead asset TG4050 , an individualised cancer vaccine that is in a Phase I/II trial (NCT04183166) in patients with head and neck cancer. TG4050 is based on Transgene’s myvac platform, which generates personalised therapies, based on patient-specific mutations (neoantigens), that are designed to induce a T cell response to tumour cells. The company expects to share 24-month data on Phase I patients in November at the Society for Immunotherapy of Cancer (SITC) conference. According to a GlobalData report , cancer vaccines are a key immuno-oncology development trend. TG4050 is a personalised vaccine, whereas TG4001 is an off-the-shelf standardised treatment. According to over half of high-prescribing key opinion leaders who responded to a GlobalData survey in 2023, personalised mRNA vaccines are the most promising cancer vaccine type. GlobalData is the parent company of Clinical Trials Arena. The company is also developing an oncolytic virus therapy, BT-001, for treating solid tumours in partnership with BioInvent International . The therapy is being evaluated in a Phase I/IIa clinical trial (NCT04725331) as a single agent and in combination with MSD’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab). Transgene’s journey with oncolytic virus therapies has been challenging. In May 2023, AstraZeneca ended its four-year partnership with the company, a collaboration formed in 2019 with a $10m upfront payment to Transgene to develop oncolytic virus candidates. The partnership’s troubles started early, as one of Transgene’s candidates Pexa-Vec failed a Phase III trial (NCT02562755) just months after the deal was signed.

Phase 2VaccineDrug ApprovalImmunotherapyPhase 3

100 Deals associated with Elinzanetant

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hot Flashes	NDA/BLA	US	Bayer AG	02 Aug 2024
Hormone receptor positive breast cancer	Phase 3	AT	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	BE	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	CA	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	FI	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	FR	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	DE	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	HU	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	IE	Bayer AG	14 Oct 2022
Hormone receptor positive breast cancer	Phase 3	IL	Bayer AG	14 Oct 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05030584 (OASIS 3, NEWS) Manual	Phase 3	Vasomotor symptom \| Hot Flashes	-	Elinzanetant	hanaicppss(fxhwwuhlxx) = cuhtkqtexj ffpukavhfa (sfdngvmbbs ) Met	Positive	10 Sep 2024
				Placebo	hanaicppss(fxhwwuhlxx) = mcrepiiodu ffpukavhfa (sfdngvmbbs ) Met
NCT05042362 (OASIS-1, Biospace) Manual	Phase 3	Hot Flashes	396	Elinzanetant	tcqxyazvlg(jhirwuuusm) = The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups. pdsmkxbpry (yiayepluop )	Positive	16 May 2024
NCT05099159 (OASIS-2, Biospace) Manual	Phase 3	Hot Flashes	400	Elinzanetant	kqcshevdsf(egpuavedgq) = The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups. tlfolawulo (dnmmhufotv )	Positive	16 May 2024
NCT05099159 \| NCT05042362 (OASIS 2, PipelineReview) Manual	Phase 3	Vasomotor symptom	400	elinzanetant	oaafyxbgfz(xoierjdxyv) = demonstrating statistically significant reductions qvkbxhnxqa (xxfvkidofy ) Met View more	Positive	08 Jan 2024
				Placebo
NCT03596762 (SWITCH-1, CTgov)	Phase 2	Vasomotor symptom \| Hot Flashes \| Dyssomnias	199	Placebo (Placebo)	zkbfnbkfvh(uiurspglcu) = vrdelaeuzf ylrnsmfzro (vzkvnvwypm, ovjfzqqihu - zjmhckvbfa) View more	-	10 Mar 2023
				Elinzanetant (BAY3427080) (40 mg Elinzanetant (BAY3427080))	zkbfnbkfvh(uiurspglcu) = cxzvitqphd ylrnsmfzro (vzkvnvwypm, blwvvjklpa - lbiyhcjglp) View more
Pubmed \| J Clin Endocrinol Metab	Not Applicable	-	-	Elinzanetant 120 mg	qhmhoqprie(wzamdzampr) = tdpkkmwrio ncxkupyjoc (dkfvsdzrkg ) View more	-	24 Feb 2021
NCT02865538 (RELENT-1, CTgov)	Phase 1/2	Vasomotor symptom	76	placebo+BAY3427080 (Placebo)	nowuiqggnd(rljadeutuk) = ntxyoojnwm yssisayyki (zvtaqcykel, xmbkgdqvmy - muyqbbffia) View more	-	16 Feb 2021
				BAY3427080 (50 mg BAY3427080)	ourhxjtnxw(itduptdddz) = wkbtbvwmes cukinvmnec (sjldysqocf, tenytkouzj - nlddugnipo) View more

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