Noema Pharma Begins Phase 2a Trial of NOE-115 for Menopause Symptoms

Noema Pharma AG, a Swiss clinical-stage biotechnology firm, has commenced dosing the first patient in a Phase 2a open-label trial investigating the safety and efficacy of NOE-115. NOE-115 is a broad-spectrum monoamine modulator aimed at addressing vasomotor symptoms (VMS), commonly known as hot flashes, as well as associated issues such as weight gain, daytime fatigue, and cognitive difficulties in menopausal women. The study, known as NOE-PPM-201, will involve 30 participants with moderate to severe VMS across six centers in the United States.

Ilise Lombardo, M.D., the CEO of Noema, highlighted the substantial medical need for a treatment that can handle the wide range of symptoms accompanying menopause. With over two million women in the U.S. entering menopause annually, Lombardo emphasized the importance of developing medications that can improve health and quality of life during this transitional period. These symptoms not only include vasomotor issues but also extend to weight gain, significant daytime fatigue, and cognitive challenges.

The NOE-PPM-201 study aims to evaluate the safety and efficacy of NOE-115 in treating VMS and additional non-VMS symptoms related to menopause. This trial is expected to provide insights into how NOE-115 can address these complex symptoms, which currently lack comprehensive treatment options. Existing hormonal and non-hormonal treatments for VMS are limited by medical contraindications, stigma, and insufficient symptomatic relief. Dr. Rebecca Dunsmoor-Su, Chief Medical Officer for Gennev and an investigator in the NOE-PPM-201 study, pointed out the persistent need for innovative treatments that target a broader range of menopausal symptoms. She noted that weight gain and daytime fatigue are significant concerns among her patients, and NOE-115 could potentially offer a unique therapeutic solution.

Menopause typically occurs in women in their 40s or early 50s and involves a natural decline in ovarian hormone production. This transition can lead to various symptoms that impact health, function, and quality of life. The global population of menopausal and postmenopausal women is expected to reach 1.2 billion within the next five years. VMS, which affects up to 80% of women during menopause, can persist for over a decade and severely impact quality of life. Nearly half of menopausal women experience moderate to severe VMS, which is often accompanied by weight changes, daytime fatigue, and cognitive difficulties.

NOE-115 is being developed as a non-hormonal, oral treatment for moderate to severe VMS associated with menopause. It has shown a favorable safety and tolerability profile in studies involving healthy volunteers. The drug aims to provide a comprehensive therapeutic option for addressing multiple central nervous system-mediated menopausal symptoms.

Noema Pharma is dedicated to advancing a diverse portfolio of transformative therapies using first-in-disease approaches for both rare and common neuroscience-based disorders. The company currently has four active Phase 2 clinical trials targeting conditions such as Trigeminal Neuralgia, Tuberous Sclerosis Complex, Tourette’s Syndrome, and VMS due to menopause. Results from these trials are anticipated by 2025. Founded by venture capital firm Sofinnova Partners, Noema Pharma is supported by investors including Forbion, Gilde Healthcare, Invus, Jeito Capital, Polaris Partners, and UPMC Enterprises.