An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *

Glytec Expands Global Collaboration with Roche to Revolutionize Hospital Diabetes Management

Transforming Global Hospital Diabetes Management

On August 27, Glytec, announced an expansion of its collaboration with Roche, that will allow the use of Glytec’s software in connection with Roche’s smart-device hospital blood glucose system, cobas^® pulse, in U.S. and world-wide markets where both solutions are available.

Glytec recognizes the significance of inpatient diabetes care and is committed to leveraging its expertise and innovative solutions to address this critical aspect of global healthcare delivery. Glytec’s flagship insulin dosing decision support software, Glucommander^®, has received widespread recognition in the U.S. for its effectiveness in addressing the challenges of inpatient diabetes care. Glytec’s advanced analytics and decision support capabilities unlock valuable insights into treatment effectiveness, empowering healthcare providers to optimize glycemic management strategies and improve outcomes.

A Commitment to Improved Patient Safety and Outcomes

“Diabetes knows no borders, profoundly impacting hospital diabetes management and patient outcomes worldwide,” said Robby Booth, co-founder and chief strategy officer at Glytec. “We are proud of our expanded collaboration with Roche, which reaffirms our commitment to addressing this critical healthcare challenge for patients, providers, and payors and positively impacting lives worldwide.”

Pioneering the Future: Meeting New Regulatory Demands in Diabetes Care

As healthcare providers face new regulatory pressures, including the U.S. Centers for Medicare & Medicaid Services (CMS) recent mandate for hospitals to report incidences of severe hypoglycemia and hyperglycemia^[1] and imposing financial penalties for non-compliance, it is crucial to unify efforts and empower our partners with the necessary tools, insights, and support to reduce patient harm by advancing clinical practices and reporting transparency. This collaboration aligns with Glytec’s mission to empower collaborative diabetes and insulin management. By leveraging Roche’s global presence and Glytec’s established track record, the collaboration seeks to elevate patient safety, enhance the cost-effectiveness of care, and drive improved outcomes worldwide.

FDA Grants Orphan Drug Designation for Neuroendocrine Carcinoma Treatment

On September 5, Abdera Therapeutics Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma.

Abdera is a San Francisco-based biopharmaceutical company leveraging its advanced antibody engineering ROVEr™ platform to design and develop tunable, precision radiopharmaceuticals for cancer.

ABD-147 is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (²²⁵Ac) to solid tumors expressing DLL3, a protein found on the surface of neuroendocrine tumors, but rarely expressed on the surface of normal cells or tissues. In 2024, Abdera plans to initiate a first-in-human Phase 1 clinical trial with ABD-147 in patients with small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) who previously received platinum-based therapy.

“Neuroendocrine carcinomas, including SCLC and LCNEC, are aggressive and challenging to treat effectively with current systemic therapies,” said Philippe Bishop, MD, chief medical officer. “By delivering a potent radioisotope to neuroendocrine tumors expressing DLL3 with custom-engineered PK properties, we believe ABD-147 has the potential to become a best-in-class DLL3-targeting treatment for aggressive neuroendocrine tumors. Along with FDA recently granting Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy, this Orphan Drug Designation for neuroendocrine carcinoma further underscores the potential of ABD 147 development to offer a significant advantage beyond approved drugs.”

The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics for rare diseases that meet certain criteria. Orphan Drug Designation provides various incentives including tax credits for qualified clinical trials, exemption from user fees, and the potential for seven years of market exclusivity after approval.

Bayer to Unveil New Data From Its Phase III OASIS 3 Long-Term Study of Elinzanetant in the Treatment of Vasomotor Symptoms Associated With Menopause

Bayer will present detailed results from the Phase III long-term study OASIS 3, evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo, at the upcoming annual meeting of The Menopause Society (TMS) which takes place from September 10 – 14, in Chicago, IL, United States.

Additional elinzanetant presentations include pooled efficacy results from the pivotal Phase III studies OASIS 1 and 2, which will be presented for the first time during the meeting.

OASIS 1, 2, and 3 data presentations:

• Poster #121: “Efficacy and Long-term Safety of Elinzanetant for the Treatment of VMS Associated with Menopause: A Phase 3 Randomized Trial (OASIS 3)”
  • Nick Panay
  • Thursday, September 12, 06:15 PM to 7:15 PM CT, Location: Riverside East, Riverside West/South – Exhibit Hall Level- East Tower
• Oral presentation: “Efficacy Of Elinzanetant for the treatment of vasomotor symptoms associated with menopause: pooled data from two Phase 3 studies”
  • James A Simon; MD
  • Thursday, September 12, 5:00 PM to 5:15 PM CT, Location: Grand Ballroom – Ballroom Level – East Tower

Additional Bayer presentations include:

• Poster #117: “Clinically meaningful improvements in vasomotor symptoms, sleep and quality of life of postmenopausal women: thresholds derived from OASIS-2 data”
  • Christian Seitz
  • Thursday, September 12, 06:15 PM to 7:15 PM CT, Location: Riverside East, Riverside West/South – Exhibit Hall Level- East Tower
• Poster #122: “Do sleep disturbances have an impact on depression and anxiety in perimenopausal and postmenopausal women? A US-based Survey”
  • Claudio N Soares, MD
  • Thursday, September 12, 06:15 PM to 7:15 PM CT, Location: Riverside East, Riverside West/South – Exhibit Hall Level- East Tower
• Poster #116: “Design of NIRVANA: a phase 2 pilot trial to assess the efficacy of elinzanetant for the treatment of sleep disturbances associated with menopause”
  • Christian Seitz
  • Thursday, September 12, 06:15 PM to 7:15 PM CT, Location: Riverside East, Riverside West/South – Exhibit Hall Level- East Tower
• Poster #37: “The effects of elinzanetant on simulated driving performance in healthy women: a phase I study”
  • Senka Djordjevic
  • Thursday, September 12, 06:15 PM to 7:15 PM CT, Location: Riverside East, Riverside West/South – Exhibit Hall Level- East Tower
• Educational Session: “Dishing on Menopause: An Invitation to Listen”
  • Donna Klassen, Wendee Lee Curtis and Susan LaPlae Miller
  • Thursday, September 12, 4:30 to 5:00 PM CT, Location: Grand Hall G to I – Ballroom Level – East Tower

Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause. Results from the OASIS 1 and 2 studies were recently published in The Journal of the American Medical Association (JAMA). Based on positive results from OASIS 1, 2 and 3, Bayer has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for elinzanetant for the treatment of moderate to severe VMS associated with menopause. Bayer will submit applications for marketing authorizations of elinzanetant to other health authorities as well.

About the OASIS 1, 2 and 3 studies

OASIS 1 and 2 (NCT05042362 and NCT05099159) are double-blind, randomized, placebo-controlled multicenter studies investigating the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks. OASIS 1 and 2 randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 (NCT05030584) is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women. OASIS 3 randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries.

About the Elinzanetant clinical development program

The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause. The OASIS 4 study is an expansion of the clinical Phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study investigating the efficacy and safety of four different doses of elinzanetant compared to placebo in women with VMS.

In addition to the OASIS program, Bayer is conducting NIRVANA (NCT06112756), an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and further evaluating the safety of elinzanetant.

About Elinzanetant

Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Elinzanetant may also decrease sleep disturbances associated with menopause.

About Vasomotor Symptoms

Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

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