An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation

The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.
The main question the study aims to answer is:
• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

Start Date31 Oct 2023

Sponsor / Collaborator

Sermonix Pharmaceuticals LLCStartup

EUCTR2020-005936-31-LT / Not yet recruitingPhase 2

An Open-label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation

Start Date24 May 2021

Sponsor / Collaborator

Sermonix Pharmaceuticals LLCStartup

NCT03781063 / Active, not recruitingPhase 2

An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor.
The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.
The secondary objectives are to evaluate:
Clinical benefit rate (CBR) and Objective Response Rate (ORR)
Duration of response
Time to response
Overall Survival (OS)
Pharmacokinetics of lasofoxifene
Quality of life (QoL): Quality of Life (QoL): vaginal assessment scale (VAS) and vulvar assessment scale (VuAS) questionnaires
Safety of lasofoxifene
Response to various ESR1 mutation (Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N).

Start Date20 Sep 2019

Sponsor / Collaborator

Sermonix Pharmaceuticals LLCStartup

[+1]

100 Clinical Results associated with Lasofoxifene Tartrate

100 Translational Medicine associated with Lasofoxifene Tartrate

100 Patents (Medical) associated with Lasofoxifene Tartrate

162

Literatures (Medical) associated with Lasofoxifene Tartrate

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

Oral lasofoxifene's effects on moderate to severe vaginal atrophy in postmenopausal women: two phase 3, randomized, controlled trials

Article

Author: Komm, Barry S. ; Simon, James A. ; Portman, David J. ; Jenkins, Simon N. ; Kagan, Risa ; Goldstein, Steven R.

Abstract:

Objective:

The aim of this study was to demonstrate whether lasofoxifene improves vaginal signs/symptoms of genitourinary syndrome of menopause.

Methods:

Two identical, phase 3 trials randomized postmenopausal women with moderate to severe vaginal symptoms to oral lasofoxifene 0.25 or 0.5 mg/d, or placebo, for 12 week. Changes from baseline to week 12 in most bothersome symptom, vaginal pH, and percentages of vaginal parabasal and superficial cells were evaluated. These coprimary endpoints were analyzed using analysis of covariance, except superficial cells, which were analyzed by the nonparametric, rank-based Kruskal-Wallis test.

Results:

The two studies enrolled 444 and 445 women (mean age, ~60 y), respectively. Coprimary endpoints at week 12 improved with lasofoxifene 0.25 and 0.5 mg/d greater than with placebo (P < 0.0125 for all). Study 1: most bothersome symptom (least square mean difference from placebo: −0.4 and −0.5 for 0.25 and 0.5 mg/d, respectively), vaginal pH (−0.65, −0.58), and vaginal superficial (5.2%, 5.4%), and parabasal (−39.9%, −34.9%) cells; study 2: most bothersome symptom (−0.4, −0.5), vaginal pH (−0.57, −0.67), and vaginal superficial (3.5%, 2.2%) and parabasal (−34.1%, −33.5%) cells. Some improvements occurred as early as week 2. Most treatment-emergent adverse events were mild or moderate and hot flushes were most frequently reported (lasofoxifene vs placebo: 13%–23% vs 9%–11%). Serious adverse events were infrequent and no deaths occurred.

Conclusions:

In two phase 3 trials, oral lasofoxifene 0.25 and 0.5 mg/d provided significant and clinically meaningful improvements in vaginal signs/symptoms with a favorable safety profile, suggesting beneficial effects of lasofoxifene on genitourinary syndrome of menopause.

01 Jan 2024·Bioinformatics and Biology Insights

Investigating Lasofoxifene Efficacy Against the Y537S + F404V Double-Mutant Estrogen Receptor Alpha Using Molecular Dynamics Simulations

Article

Author: Bouricha, El Mehdi ; Hakmi, Mohammed

Estrogen receptor alpha (ERα) plays a critical role in breast cancer (BC) progression, with endocrine therapy being a key treatment for ERα + BC. However, resistance often arises due to somatic mutations in the ERα ligand-binding domain (LBD). Lasofoxifene, a third-generation selective estrogen receptor modulator, has shown promise against Y537S and D538G mutations. However, the emergence of a novel F404 mutation in patients with pre-existing LBD mutations raises concerns about its impact on lasofoxifene efficacy. This study investigates the impact of the dual Y537S and F404V mutations on lasofoxifene’s efficacy. Using molecular dynamics simulations and molecular mechanics/Poisson-Boltzmann surface area (MM-PBSA) free energy calculations, we found that the dual mutation reduces lasofoxifene binding affinity and binding free energy, disrupts crucial protein-ligand interactions, and induces significant conformational changes in the ligand-binding pocket. These alterations are likely due to the loss of the pi-pi stacking interaction in the F404V mutation. These findings suggest a potential reduction in lasofoxifene efficacy due to the dual mutation. Further experimental validation is required to confirm these results and fully understand the impact of dual mutations on lasofoxifene’s effectiveness in ERα + metastatic BC.

01 Dec 2023·Annals of oncology : official journal of the European Society for Medical Oncology

Open-label, phase II, multicenter study of lasofoxifene plus abemaciclib for treating women with metastatic ER+/HER2− breast cancer and an ESR1 mutation after disease progression on prior therapies: ELAINE 2

Article

Author: Peguero, J A ; Cherian, M A ; Goetz, M P ; Barve, M ; Anderson, I C ; Damodaran, S ; Portman, D J ; Blau, S ; Elkhanany, A ; O'Sullivan, C C ; Plourde, P V ; Moore, H C F

BACKGROUND:

Acquired ESR1 mutations in estrogen receptor-positive (ER+) metastatic breast cancer (mBC) drive treatment resistance and tumor progression; new treatment strategies are needed. Lasofoxifene, a next-generation, oral, endocrine therapy and tissue-specific ER antagonist, provided preclinical antitumor activity, alone or combined with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in ESR1-mutated mBC.

PATIENTS AND METHODS:

In the open-label, phase II, ELAINE 2 trial (NCT04432454), women with ESR1-mutated, ER+/human epidermal growth factor receptor 2-negative (HER2-) mBC who progressed on prior therapies (including CDK4/6i) received lasofoxifene 5 mg/day and abemaciclib 150 mg b.i.d until disease progression/toxicity. The primary endpoint was safety/tolerability. Secondary endpoints included progression-free survival (PFS), clinical benefit rate (CBR), and objective response rate (ORR).

RESULTS:

Twenty-nine women (median age 60 years) participated; all but one were previously treated with a CDK4/6i (median duration 2 years). The lasofoxifene-abemaciclib combination was well tolerated with primarily grade 1/2 treatment-emergent adverse events (TEAEs), most commonly diarrhea, nausea, fatigue, and vomiting. One patient (with no prior CDK4/6i) discontinued treatment due to grade 2 diarrhea. No deaths occurred during the study. Median PFS was 56.0 weeks [95% confidence interval (CI) 31.9 weeks-not estimable; ∼13 months]; PFS rates at 6, 12, and 18 months were 76.1%, 56.1%, and 38.8%, respectively. CBR at 24 weeks was 65.5% (95% CI 47.3% to 80.1%). In 18 patients with measurable lesions, ORR was 55.6% (95% CI 33.7% to 75.4%). ESR1-mutant circulating tumor DNA (ctDNA) allele fraction decreased from baseline to week 4 in 21/26 (80.8%) patients.

CONCLUSIONS:

Lasofoxifene plus abemaciclib had an acceptable safety profile, was well tolerated, and exhibited meaningful antitumor activity in women with ESR1-mutated, ER+/HER2- mBC after disease progression on prior CDK4/6i. Observed decreases in ESR1-mutant ctDNA with lasofoxifene concordant with clinical response suggest target engagement. If the ELAINE 2 findings are confirmed in the initiated, phase III, ELAINE 3 trial, these data could be practice-changing and help address a critical unmet need.

News (Medical) associated with Lasofoxifene Tartrate

06 Jun 2024

·www.biospace.com

Sermonix Pharmaceuticals Announces Chinese Approval of Investigational New Drug Application for Lasofoxifene

IND approval in China allows Shanghai Henlius Biotech, Sermonix’s Chinese development partner for oral lasofoxifene, to enroll ELAINE-3 trial patients in China Under strategic collaboration agreement signed in January, Henlius received exclusive rights from Sermonix to develop, manufacture and commercialize oral lasofoxifene in China Sermonix and Henlius will engage with PMDA and collaborate on expedited co-development of oral lasofoxifene in Japan COLUMBUS, Ohio, June 06, 2024 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), today announced that China’s National Medical Products Administration (NMPA) approved the investigational new drug application (IND) for oral lasofoxifene (HLX78 in China) submitted with the assistance of Chinese development partner Shanghai Henlius Biotech, Inc. (2696.HK). The IND approval allows Henlius to join the ongoing global registrational ELAINE-3 trial with responsibility in China. ELAINE-3 (NCT05696626), the third Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) trial, is assessing the efficacy of oral lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio®) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. This month, Henlius expanded its license from Sermonix to add additional Asia territories for upfront, milestone and royalty payments. The agreement also allows Henlius to share with Sermonix expedited co-development of oral lasofoxifene in Japan. Sermonix has completed a Phase 1 Japanese PK study and, together with Henlius, will begin engagement with the Pharmaceuticals and Medical Devices Agency (PMDA) to address a regulatory path to study lasofoxifene in Japan, which is an important region for expanded global access to lasofoxifene investigation. “With active ELAINE-3 enrollment already underway in the U.S., Canada, EU and Israel, we are pleased to announce that Henlius, our Chinese development partner for oral lasofoxifene, received approval for its investigational new drug application,” said Dr. David Portman, Sermonix founder and chief executive officer. “This milestone clears Henlius to enroll patients in ELAINE-3 in China, therefore further diversifying our patient population and potentially helping more people to better confront this terrible disease.” “The collaboration between Henlius and Sermonix started in January 2024,” said Ms. Ping Cao, Henlius chief business development officer and SVP of business development. “In mere months from agreement to amendment, our unified dedication shines, turning swift collaboration and full-hearted implementation into tangible success – as underscored by our product's IND approval in China." Oral lasofoxifene is an investigational novel targeted endocrine therapy in clinical development that has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. In two completed Phase 2 clinical studies (ELAINE-1 and ELAINE-2), lasofoxifene demonstrated anti-tumor activity against tumors with ESR1 mutations as a monotherapy and in combination with abemaciclib, a CDK4/6 inhibitor. Lasofoxifene’s bioavailability and potent activity in mutations of the estrogen receptor, in addition to its potential to improve sexual and urogenital health with a well-tolerated profile, could hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, and, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer. Breast cancer is the second most diagnosed cancer in the world, according to GLOBOCAN 2022. There were around 2.3 million new cases of breast cancer in 2022 globally, including more than 357,000 in China.1 ER+ breast cancer comprises 60-70% of all breast cancers.2 Endocrine therapy remains the mainstay treatment for ER+ breast cancer and the most widely used class of aromatase inhibitor (AI) has been recommended by the National Comprehensive Cancer Network (NCCN) and Chinese Society of Clinical Oncology (CSCO) guidelines to be the adjuvant and first-line standard of care for patients with ER+/HER2- breast cancer.3,4 However, almost all patients treated with AIs in the advanced setting develop resistance,5 with ESR1 mutations being one of the most prevalent alterations, present in up to 40% of patients and a significant mechanism of resistance to endocrine therapy.6 Currently, there are limited treatment options for ER+/HER2- breast cancer with ESR1 mutations, and thus a large clinical need exists. [1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and MortalityWorldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. [2] Ignatiadis M, Sotiriou C. Luminal breast cancer: from biology to treatment[J]. Nat Rev Clin Oncol, 2013, 10(9): 494-506. doi: 10.1038/nrclinonc.2013.124. [3] Chinese Society of Clinical Oncology (CSCO) Breast Cancer Guidelines 2023 [4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2023 [5] Rozeboom B, Dey N, De P. ER+ metastatic breast cancer: past, present, and a prescription for an apoptosis-targeted future. Am J Cancer Res. 2019;9(12):2821-2831. Published 2019 Dec 1. [6] Spoerke JM, Gendreau S, Walter K, et al. Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant. Nat Commun. 2016;7:11579. Published 2016 May 13. doi:10.1038/ncomms11579 About Sermonix Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical study of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. To learn more about Sermonix, visit SermonixPharma.com. To learn more about the ELAINE studies, visit DiscoverElaine.com. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 3 have been approved for marketing in overseas markets, 23 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer EAttias@sermonixpharma.com (973) 723-7832

Phase 2License out/inPhase 1Phase 3Drug Approval

30 May 2024

·www.biospace.com

Sermonix Pharmaceuticals to Present Poster on ELAINE-3 Trial in Progress at ASCO 2024

COLUMBUS, Ohio, May 30, 2024 (GLOBE NEWSWIRE) --Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), today announced it will present a poster updating the progress of its Phase 3 ELAINE-3 clinical trial at the annual meeting of the American Society of Clinical Oncology (ASCO). ASCO 2024 will be held May 31-June 4, 2024, at McCormick Place in Chicago. Poster Details: Title: Open-label, randomized, multicenter, phase 3, ELAINE-3 study of the efficacy and safety of lasofoxifene plus abemaciclib for treating ER+/HER2-, locally advanced or metastatic breast cancer with an ESR1 mutation. Abstract Number: TPS1127 Poster Board Number: 101b Session Date/Time: June 2, 2024, 9 a.m.-noon CDT A global registrational study, the third Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) trial is assessing the efficacy of oral lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio®) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. “Sermonix looks forward to updating our peers at ASCO 2024 about the progress of ELAINE-3, which is actively enrolling in the U.S., Canada, Europe and Israel,” said Dr. David Portman, Sermonix founder and chief executive officer. “In previous trials, lasofoxifene demonstrated compelling anti-tumor activity against tumors with increasingly prevalent ESR1 mutations and potential benefit on quality of life with respect to vaginal and sexual health. We are excited to gain a greater understand of lasofoxifene’s potential as ELAINE-3 progresses, and hopefully bring it one important step closer to patients.” About Sermonix Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical study of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at SermonixPharma.com. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer EAttias@sermonixpharma.com (973) 723-7832

Phase 3ASCO

19 Apr 2024

·www.biospace.com

Sermonix to Host KOL Fireside Chat on Advancements in the Metastatic Breast Cancer Treatment Landscape on April 22, 2024

COLUMBUS, Ohio, April 19, 2024 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC) harboring ESR1 mutations, today announced it will host a virtual KOL fireside chat on Monday, April 22, 2024 from noon to 1 p.m. ET, featuring Senthil Damodaran, M.D., Ph.D. (MD Anderson Cancer Center) and Seth Wander, M.D., Ph.D. (Harvard Medical School, Massachusetts General Hospital) to discuss the unmet need and current treatment landscape for metastatic breast cancer. To register, click here. The event will focus on the company's ELAINE (Evaluating Lasofoxifene in ESR1 Mutations) studies investigating lasofoxifene in patients with locally advanced or metastatic estrogen receptor-positive/human epidermal growth factor 2-negative (ER+/HER2-) breast cancer expressing an estrogen receptor 1 (ESR1) mutation. With Phase 2 ELAINE-1 and ELAINE-2 studies both completed and having demonstrated compelling anti-tumor activity against tumors with increasingly prevalent ESR1 mutations, enrollment is currently open for ELAINE-3, a large, randomized, Phase 3 study with clinical trial sites across the United States, Europe, Asia-Pacific, Israel, and Canada. A live question and answer session will follow the formal presentations. About Senthil Damodaran, M.D., Ph.D. Senthil Damodaran, M.D., Ph.D. is an associate professor in breast medical oncology with a joint appointment in Investigational Cancer Therapeutics at the MD Anderson Cancer Center. His research focuses on 1) biomarker-driven clinical trials, 2) application of omics for target discovery in breast cancers, and 3) characterization of secondary drug resistance mechanisms. At MD Anderson, he leads the department’s biomarker-directed clinical and translational efforts and serves as the lead for multiple biomarker-enriched clinical studies including CTEP and ETCTN trials. Dr. Damodaran also serves on the American Society of Clinical Oncology and American Board of Internal Medicine expert panels. About Seth Wander, M.D., Ph.D. Seth Wander, M.D., Ph.D. is a medical oncologist at the Massachusetts General Hospital with a clinical and translational research interest in breast cancer and cancer genomics. Dr. Wander completed his undergraduate degree at Cornell University, where he studied Molecular and Cell Biology and graduated magna cum laude with distinction in research. He pursued his M.D. and Ph.D. in Cancer Biology at the University of Miami. Dr. Wander completed his internship and residency in internal medicine at the Massachusetts General Hospital and his fellowship training in medical oncology at the Dana-Farber Cancer Institute and the Massachusetts General Hospital Cancer Center. Dr. Wander is active in both the clinic and laboratory, where his research interests involve genomic mechanisms of resistance to targeted therapies in metastatic breast cancer. Dr. Wander has published more than forty peer-reviewed manuscripts focused on the emerging field of precision medicine and related topics in oncology. His research is focused on leveraging genetic and molecular sequencing results to understand how cancers become resistant to standard therapies in order to develop novel, personalized treatment strategies. He is an assistant professor of medicine at Harvard Medical School and remains engaged in teaching medical students, residents, and fellows. He was a recipient of the 2017 Dana-Farber Cancer Institute Wong Family Translational Research Award and a 2018 recipient of the Conquer Cancer Foundation/American Society of Clinical Oncology Young Investigator Award. Dr. Wander, as part of a multidisciplinary team, leads a variety of clinical trials focused on developing novel clinical strategies for patients with metastatic breast cancer and resistance to standard hormonal and targeted agents. He has presented educational sessions and original research both nationally and internationally related to drug resistance and the development of personalized treatment strategies for breast cancer. About Sermonix Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at SermonixPharma.com. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer EAttias@sermonixpharma.com (973) 723-7832

Phase 2Phase 3Executive ChangeASCO

100 Deals associated with Lasofoxifene Tartrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Lasofoxifene Tartrate	G03	DB06202

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Osteoporosis, Postmenopausal	EU	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009
Osteoporosis, Postmenopausal	IS	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009
Osteoporosis, Postmenopausal	LI	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009
Osteoporosis, Postmenopausal	NO	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Atrophic Vaginitis	NDA/BLA	US	Sermonix Pharmaceuticals LLCStartup	-
ER-positive/HER2-negative/ ESR1-mutated breast cancer	Phase 3	CN	Shanghai Henlius Biotech, Inc.	12 Jul 2024
ER-positive/HER2-negative Breast Cancer	Phase 3	US	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	AU	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	BE	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	CA	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	CZ	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	FR	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	DE	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	IL	Sermonix Pharmaceuticals LLCStartup	31 Oct 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03781063 (ELAINE 1, Pubmed \| Ann Oncol)	Phase 2	ER-positive/HER2-negative/ ESR1-mutated breast cancer ESR1 mutation	103	Lasofoxifene 5 mg	hcgnszjgji(gpdisqtsjy) = aimhjndkil xhheodeshx (whzfqtgncf ) View more	Positive	01 Dec 2023
				Fulvestrant 500 mg	hcgnszjgji(gpdisqtsjy) = ocpsmiozux xhheodeshx (whzfqtgncf ) View more
NCT03781063 (ELAINE 1, ESMO2022) Manual	Phase 2	ER-positive/HER2-negative Breast Cancer Second line ER+/HER2-/ESR1-mutated	103	lasofoxifene	ogmaqwgact(jjmswozhbk) = wnmbccgpsj ksuwpufvwc (ibswghunqm, 2.82 - 8.04) View more	Superior	10 Sep 2022
				fulvestrant	ogmaqwgact(jjmswozhbk) = wsdfreaahz ksuwpufvwc (ibswghunqm, 2.93 - 6.04) View more
NCT00141323 (PEARL, Pubmed \| J Am Coll Cardiol)	Phase 3	Osteoporosis, Postmenopausal	8,556	Lasofoxifene 0.5 mg/d	(jujiflhirz): hazard ratio = 0.56 (95% CI, 0.32 - 0.98) View more	-	26 Oct 2010
				Placebo
NCT00141323 (Pubmed \| Br Dent J)	Phase 3	Osteoporosis, Postmenopausal	8,556	Lasofoxifene 0.25 mg	syejjvztck(hgjhwaveef) = vawqqvpdha tzngjooxuk (ypetopnxmb ) View more	-	25 Feb 2010
				Lasofoxifene 0.5 mg	syejjvztck(hgjhwaveef) = wbywzilttv tzngjooxuk (ypetopnxmb ) View more

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