NOE-115 has the potential to benefit Vasomotor Symptoms (VMS) during menopause as well as associated clinical challenges including weight gain, daytime fatigue, and cognitive symptoms
BASEL, Switzerland, May 22, 2024 – Noema Pharma AG, a clinical-stage biotech company targeting debilitating neuroscience-based disorders, today announced the first patient has been dosed in a Phase 2a open-label study evaluating the safety and efficacy of NOE-115, a broad-spectrum monoamine modulator, in women with vasomotor symptoms (VMS, also referred to as “hot flashes”) as well as other symptoms such as weight gain, daytime fatigue and cognitive difficulties due to menopause. “The initiation of this study marks our fifth Phase 2 program to enter the clinic as we seek to develop transformative medicines for underserved conditions which are rooted in neuroscience,” said Ilise Lombardo, M.D., chief executive officer of Noema. “With over 2 million women in the U.S. entering menopause annually, there is significant medical need for a treatment option capable of addressing a broad constellation of symptoms that accompany the menopause transition, so that women are able to maintain their health and quality of life. These include vasomotor symptoms as well as weight gain, significant daytime fatigue and cognitive difficulties.”
NOE-PPM-201 is a Phase 2a open-label study that is designed to examine the safety and efficacy of NOE-115, a monoamine modulator, in patients with vasomotor symptoms due to menopause and assess additional associated non-VMS menopausal symptoms. The trial will initially evaluate 30 women with moderate to severe VMS at 6 centers in the US.
While there are hormonal and non-hormonal treatments available for women with VMS, their acceptance can be limited due to medical reasons, stigma associated with treatment, and narrow symptomatic relief. There remains a significant need for innovative treatments that address the broader group of symptoms that women in the menopause transition struggle with. Weight gain and daytime fatigue are often of concern to my patients. NOE-115 may be a unique therapeutic option with the potential to target multiple moderate-to-severe CNS-mediated menopausal symptoms.
Dr. Rebecca Dunsmoor-Su, MD
Chief Medical Officer for Gennev and an investigator in the NOE-PMM-201 study