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Entera’s EB613, the First Once Daily PTH(1-34) Tablet Treatment Dedicated to Post-Menopausal Women with High Risk Osteoporosis Abstract Selected for Presentation at the ASBMR 2024 Annual Meeting – Key SABRE Update Also Expected

JERUSALEM, Aug. 01, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of orally delivered peptides and therapeutic proteins, today announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting which will be held on September 27–30, 2024 in Toronto, ON, Canada.

EB613 is being developed as the first once–daily oral anabolic (bone forming) PTH(1–34) mini tablet therapy for post–menopausal women with high risk osteoporosis. It is estimated that 50 percent of women and 20 percent of men over the age of 50 are at risk of a fragility fractures and approximately 1 in 5 adults will die within the year following a hip fracture. Post menopausal osteoporosis afflicts more women than cancer and cardiovascular disease and is a serious health concern for an estimated 200 million women globally.

“Available injectable anabolic treatments, while efficacious and recommended across medical guidelines, unfortunately do not provide a viable solution for most women with high–risk osteoporosis requiring an anabolic intervention. Our EB613 program is dedicated to address the treatment chasm in current osteoporosis care and hopefully present a treatment for the majority of women to adequately manage their post–menopause bone health with a simple once daily tablet treatment. Importantly, we look forward to the SABRE (Study to Advance BMD as a Regulatory Endpoint) UPDATE at the ASBMR 2024 meeting. On March 26th 2024, Entera echoed the ASBMR announcement that the U.S. Food and Drug Administration (FDA) had communicated to SABRE that a ruling to qualify bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs would be provided within 10 months. The proposed registrational Phase 3 study for EB613, is designed to meet the quantitative BMD thresholds proposed by SABRE,” said Miranda Toledano, Chief Executive Officer at Entera.

Abstract Title:  3079 – EB613 (Oral PTH(1–34) Tablets) Shows Differentiated Pharmacokinetic Profile From Forteo – New Results from Phase 1b Open–Label Study
Presentation Number:  Sat–LB 589
Session Date/Time: Saturday, September 28, 2024, 2:15 – 3:45 PM 

SABRE Project Update

Speakers: Dennis M. Black , PhD, University of California, United States; Theresa E. Kehoe , MD, CDER/FDA, United States

Session Date / Time: Sunday September 29, 2024 9:45 – 10:45 AM

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9197414)

Policymakers should recognise #SelfCareIsHealthcare in campaign bid to address global health challenges

  • Self–care describes the role of individuals in preventing disease, promoting and maintaining their mental and physical health, and actively participating in their healthcare
  • A wealth of evidence demonstrates the significant value of self–care to individuals, health systems, society and the economy

  • Despite this, self–care is not universally viewed or understood as a healthcare intervention and there is unequal access to self–care interventions around the world

GENEVA, July 24, 2024 (GLOBE NEWSWIRE) — The Global Self–Care Federation (GSCF) is urgently calling upon policymakers and health leaders worldwide to embrace self–care as an essential component of healthcare, by ensuring it is fully integrated into national health systems and policies, as part of this year’s International Self–Care Day on July 24.

The concept of self–care was first recognised by the World Health Organization (WHO) in 1983. It describes the role of individuals in preventing disease, promoting and maintaining their mental and physical health, and actively participating in their healthcare. Examples of self–care practices include medicines, devices, diagnostics digital tools as well as healthy lifestyle choices.

As health systems worldwide continue to face a range of challenges – from increased demand on services, to inequity in access to healthcare – evidence shows that self–care can:

  • avert an estimated 3.9 million premature deaths each year, through physical activity alonei
  • save nearly $120 billion each year for global healthcare systems and, therefore, national economiesii
  • improve the autonomy and agency of disadvantaged groups, including women and girls, in managing their own healthiii
  • provide a legitimate tool in the pursuit of universal health coverageiv

Judy Stenmark, Director General of GSCF, said: “Right now, health systems around the world are struggling, long–term ill health is on the rise, health disparities are growing and the impact of COVID–19 is still being felt. Addressing these requires new approaches and strategies, including evidence–based self–care – to achieve sustainable health services fit for the future.

“Our ‘Self–care is healthcare’ campaign is all about fuelling the movement for self–care to be recognised as an integral part of healthcare. It aims to drive greater awareness and recognition of the potential of self–care to people and policymakers across the world. At GSCF, we firmly believe that everyone benefits when there is a greater choice of healthcare options and more accessible entries to care.”

Building on this year’s International Self–Care Day, GSCF is urging members and campaigners to rally behind the #SelfCareIs movement. This initiative aims to educate global audiences about the critical link between self–care and healthcare. It also encourages engagement with local policymakers and healthcare providers to call on them to put in place plans for the urgent integration of self–care into the healthcare delivery continuum.

To find out more and to get involved, please visit the campaign website: https://self–care–is–healthcare.org/.

Notes to editors

WHO definition of self–care
Self–care is the ability of individuals, families and communities to promote health, prevent disease, maintain health, and cope with illness and disability with or without the support of a health worker.

About The Global Self–Care Federation
The Global Self–Care Federation represents associations and manufacturers in the self–care industry, promoting sustainable and better global health outcomes for all. The Global Self–Care Federation is the go–to source of information for the self–care industry. We work closely with our members and relevant stakeholder groups to deliver better choice, better care and better value. By placing the benefits of self–care at the heart of what we do, promoting industry transparency, and supporting the regulated use of health data, we ensure that self–care continues to play its increasingly vital role in sustainable healthcare, worldwide. For more information please visit: www.selfcarefederation.org.

About International Self–Care Day
International Self–Care Day is held annually on July 24th (7/24), to highlight that the benefits of self–care are experienced 24 hours a day, seven days a week. International Self–Care Day raises awareness of the value of self–care and the benefit that effective self–care can bring to both individuals and healthcare systems as a vital foundation of health.

i https://www.who.int/news–room/fact–sheets/detail/self–care–health–interventions#:~:text=Self%2Dcare%20is%20the%20ability,a%20health%20or%20care%20worker.
ii https://www.selfcarefederation.org/ecosoc–report
iii https://www.nature.com/articles/s41591–024–02844–8#Sec19
iv https://www.who.int/health–topics/self–care#tab=tab_1

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b4ee215a–f0b4–4837–a280–90659dcf5aa5


GLOBENEWSWIRE (Distribution ID 1000982941)

CSL Behring Announces First Two Patients Treated with HEMGENIX® (etranacogene dezaparvovec) Gene Therapy for Hemophilia B in Europe

MARBURG, Germany, July 04, 2024 (GLOBE NEWSWIRE) — Global biotechnology leader CSL Behring (ASX: CSL) today announced that two hemophilia B patients were treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec) at Hemophilia Treatment Centers in France. This milestone achievement makes HEMGENIX® the first gene therapy administered as a treatment in a real–world setting for hemophilia B in Europe.

HEMGENIX® is the first one–time gene therapy approved in Europe for the treatment of adults with severe and moderately severe hemophilia B, an inherited bleeding disorder caused by the lack of Factor IX (a protein needed to produce blood clots to stop bleeding). It is used in adults without a history of Factor IX inhibitors.1

Following European Commission approval, HEMGENIX® was the first ever therapy to be granted Direct Access in France2, thus enabling the first patients to be treated in Europe outside of the clinical program.

Though effective, current therapies can be time intensive and require regular treatment that can have a substantial impact on a patient’s daily life.3 HEMGENIX® offers a one–time treatment, allowing people living with hemophilia B to produce their own Factor IX, which can lower the risk of bleeding.4

“Only a few decades ago, gene therapy for hemophilia was a distant concept, which has now become reality. Accordingly, the first two patients treated with HEMGENIX® since receiving European approval is a major accomplishment and a testament to the joint commitment of the hemophilia B community, as well as the access and reimbursement authorities, in bringing innovative therapies to patients,” said Dr Lutz Bonacker SVP and General Manager, CSL Behring Commercial Operations Europe. “This milestone has been made possible by the innovative Direct Access scheme adopted in France, allowing patients to benefit from early access to pioneering treatments. We are encouraged to see increasing access to gene therapies in European countries and are fully committed to ensuring that access to potentially life–changing treatment continues.”

HEMGENIX® was granted conditional marketing authorisation by the European Commission (EC) for the European Union and European Economic Area in February 2023, following approval from the U.S. Food and Drug Administration (FDA) in November 2022. It has also been approved by Health Canada, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), Switzerland’s Swissmedic and Australia’s Therapeutic Goods Administration (TGA).

The multi–year clinical development of HEMGENIX® was led by uniQure and sponsorship of the clinical trials transitioned to CSL after it licensed global rights to commercialise the treatment.

About Hemophilia B

Hemophilia B is a life–threatening rare disease. People with the condition are particularly vulnerable to bleeds in their joints, muscles, and internal organs, leading to pain, swelling, and joint damage. Current treatments for moderate to severe hemophilia B include life–long prophylactic infusions of factor IX to temporarily replace or supplement low levels of the blood–clotting factor.  

About HEMGENIX®

HEMGENIX® is a gene therapy that reduces the rate of abnormal bleeding in eligible people with hemophilia B by enabling the body to continuously produce factor IX, the deficient protein in hemophilia B. It uses AAV5, a non–infectious viral vector, called an adeno–associated virus (AAV). The AAV5 vector carries the Padua gene variant of Factor IX (FIX–Padua) to the target cells in the liver, generating factor IX proteins that are 5x–8x more active than normal. These genetic instructions remain in the target cells, but generally do not become a part of a person’s own DNA. Once delivered, the new genetic instructions allow the cellular machinery to produce stable levels of factor IX.

About the Pivotal HOPE–B Trial

The pivotal Phase III HOPE–B trial is an ongoing, multinational, open–label, single–arm study to evaluate the safety and efficacy of HEMGENIX®. Fifty–four adult hemophilia B patients classified as having moderately severe to severe hemophilia B and requiring prophylactic factor IX replacement therapy were enrolled in a prospective, six–month or longer observational period during which time they continued to use their current standard of care therapy to establish a baseline Annual Bleeding Rate (ABR). After the six–month lead–in period, patients received a single intravenous administration of HEMGENIX® at the 2×10^13 gc/kg dose. Patients were not excluded from the trial based on pre–existing neutralizing antibodies (NAbs) to AAV5.

A total of 54 patients received a single dose of HEMGENIX® in the pivotal trial, with 52 patients completing at least three years of follow–up. The primary endpoint in the pivotal HOPE–B study was ABR 52 weeks after achievement of stable factor IX expression (months 7 to 18) compared with the six–month lead–in period. For this endpoint, ABR was measured from month seven to month 18 after infusion, ensuring the observation period represented a steady–state factor IX transgene expression. Secondary endpoints included assessment of factor IX activity.

No serious treatment–related adverse reactions were reported. One death resulting from urosepsis and cardiogenic shock in a 77–year–old patient at 65 weeks following dosing was considered unrelated to treatment by investigators and the company sponsor. A serious adverse event of hepatocellular carcinoma was determined to be unrelated to treatment with HEMGENIX® by independent molecular tumour characterization and vector integration analysis. No inhibitors to factor IX were reported. 

Long–term three–year data presented at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) 2024 continue to reinforce the potential long–lasting efficacy and safety of HEMGENIX® and the ongoing benefit of this treatment for people living with hemophilia B.

About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/Vita. For more information about CSL, visit CSL.com.

Media Contacts
Stephanie Fuchs
Mobile: +49 151 584 388 60
Email: [email protected]

References

1 European Medicines Agency. First Gene therapy to treat haemophilia B. Available at: https://www.ema.europa.eu/en/news/first–gene–therapy–treat–haemophilia–b. [Accessed May 2024].
2 Republique Française. Légifrance: Article 62 of Law No. 2021–1754. Available at: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000048551003 [Accessed May 2024].
3 Leebeek, F & Miesbach, W. (2021) Gene therapy for haemophilia: a review on clinical benefit, limitations, and remaining issues. Blood. Vol 138, Issue 11. pp923–931.
4 Coppens M et al. Etranacogene dezaparvovec gene therapy for haemophilia B (HOPE–B): 24–month post–hoc efficacy and safety data from a single–arm, multicentre, phase 3 trial. The Lancet Haematology 2024; 11(4):E265–E275.


GLOBENEWSWIRE (Distribution ID 1000969961)