Noema Pharma announces first patient dosed in Phase 2a Study of NOE-115, a first-in-class investigational therapy for the treatment of vasomotor symptoms and additional symptoms associated with menopause

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,” said Dr. Rebecca Dunsmoor-Su, MD, Chief Medical Officer for Gennev and an investigator in the NOE-PMM-201 study. She added, “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.”

About Menopause

In the next 5 years, the global population of menopausal and postmenopausal women is projected to hit 1.2 billion. As a natural process, menopause usually occurs in women in their 40s or early 50s, when reduced hormone production by the ovaries can lead to various symptoms which can significantly and broadly affect a woman’s health, function, quality of life.

About Vasomotor Symptoms (VMS)

VMS (also referred to as hot flashes) are reported by up to 80% of women during the menopausal transition and can last 10 years or more from the onset of menopause. Nearly half of menopausal women report moderate or severe VMS symptoms, with relevant impact on quality of life. A large proportion of women with moderate or severe VMS due to menopause also report substantial changes in weight, daytime wakefulness, and mental processing that significantly impact wellness during the menopausal transition.

About NOE-115

NOE-115 is a broad-spectrum monoamine modulator in mid-stage clinical development as a non-hormonal treatment for moderate to severe VMS associated with menopause, administered orally once daily. NOE-115 has been safe and well-tolerated to date in studies in healthy volunteers.

About Noema Pharma

Noema Pharma is a clinical-stage biotech company advancing a differentiated portfolio of transformative therapeutics utilizing first-in-disease approaches targeting orphan and large neuroscience-based indications with high unmet need. Noema has four programs currently in active Phase 2 clinical trials evaluating pain in Trigeminal Neuralgia, seizures in Tuberous Sclerosis Complex, Tourette’s Syndrome and vasomotor symptoms due to menopause with readouts expected by 2025. Noema was founded by leading venture capital firm Sofinnova Partners and is supported by current investors including Forbion, Gilde Healthcare, Invus, Jeito Capital, Polaris Partners and UPMC Enterprises. Learn more at www.noemapharma.com.