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 News Release - February 4, 2019

Sojournix Appoints Ruth Thieroff-Ekerdt, M.D. As Senior Vice President And Chief Medical Officer

Key Appointment in the Advancement of SJX-653 as a Novel and Selective NK3 Antagonist in Clinical Development as a Once-Daily Non-Hormonal Treatment for Menopausal Vasomotor Symptoms, or "Hot Flashes"

WALTHAM, Mass., Feb. 4, 2019 -- (Healthcare Sales & Marketing Network) -- Sojournix, a clinical stage biopharmaceutical company focused on developing and commercializing novel therapies for the treatment of women's health and neuroendocrine disorders, today announced the appointment of Ruth Thieroff-Ekerdt, M.D., as Senior Vice President and Chief Medical Officer. Dr. Thieroff-Ekerdt is an experienced clinician and drug developer who brings more than three decades of experience in clinical development, including translational medicine, registrational trials, global drug submissions, and new product approvals across diverse therapeutic areas.

"We are delighted to welcome Dr. Thieroff-Ekerdt to the Sojournix team. Ruth's deep experience designing and leading successful clinical development programs at all stages of development, her passion for rigorous clinical science, and her dedication to patients will be invaluable as we advance clinical development of SJX-653 for the treatment of moderate to severe vasomotor symptoms due to menopause and additional potential indications," said Dan Grau, President, CEO, and co-founder of Sojournix.

"I'm excited to join the outstanding team at Sojournix and lead the next phase of clinical development for SJX-653, an exceptional compound with the potential to make a significant difference in the lives of women suffering from vasomotor symptoms," said Dr. Thieroff-Ekerdt. "There is a large and well-recognized unmet medical need for a safe and effective non-hormonal treatment option for moderate to severe vasomotor symptoms in postmenopausal women, and SJX-653 has the potential to become a best-in-class once-daily therapy which will be well-received by these patients."

Over the span of her career, Dr. Thieroff-Ekerdt has provided clinical leadership across diverse therapeutic areas, including endocrinology, women's health, dermatology, gastrointestinal diseases, autoimmune diseases, and rare diseases, and successfully interacted with both U.S. and European regulators leading to multiple drug submissions and product approvals. Dr. Thieroff-Ekerdt has previously served as Chief Medical Officer at Kaleido Biosceinces, Strongbridge Biopharma Plc, Aptalis Pharmaceuticals, and Eurand Pharmaceuticals and as Vice President Clinical and Medical Affairs at Bayer Consumer Care. Earlier in her career Dr. Thieroff-Ekerdt held clinical operations, clinical science and preclinical/discovery positions of increasing responsibility at Berlex Inc. and Schering AG (now Bayer). Dr. Thieroff-Ekerdt, who is fluent in German and English, earned her medical degree at the Free University of Berlin and specialized in pharmacology and clinical pharmacology. Dr. Thieroff-Ekerdt has authored over 27 publications and is an inventor on over 33 patents.

About SJX-653

SJX-653 is a novel and selective NK3 antagonist in clinical development as a once-daily non-hormonal therapy for moderate to severe vasomotor symptoms (commonly called "hot flashes") due to menopause.

About Neurokinin-3 (NK3)

Vasomotor symptoms are believed to be caused by excessive NK3 signaling in the median preoptic nucleus, an area of the brain responsible for regulating body temperature. During menopause, the decline in estrogen levels leads to an over-production of neurokinin B (NKB), an endogenous neurotransmitter that binds to and activates NK3 receptors in the median preoptic nucleus. By reducing the excessive signaling of NKB at the NK3 receptor, NK3 antagonism helps restore the body's normal thermoregulation capacity, and therefore has the potential to alleviate menopausal vasomotor symptoms. As a mechanism of action for treating vasomotor symptoms, NK3 antagonism is clinically-validated and has demonstrated efficacy comparable to hormone therapy. In addition, a human genome study has revealed a genetic association between vasomotor symptoms and the tachykinin 3 gene that encodes the NK3 receptor.

About Vasomotor Symptoms (VMS)

Vasomotor symptoms are characterized by sudden and recurrent sensations of intense heat, or "hot flashes," often accompanied by elevated heart rate, sweating, skin reddening, and the disruption of both daily activities and sleep. Over 2 million women enter menopause each year in the United States alone and the majority of them experience vasomotor symptoms. The median duration of vasomotor symptoms due to menopause is approximately 7 years.

While hormone therapy is an effective treatment for menopausal VMS, many women choose to avoid hormone therapy due to concerns about safety risks highlighted in hormone therapy product labels. Hormone therapy is contraindicated in women who have a history of certain medical conditions. Currently available non-hormonal agents, such as selective serotonin reuptake inhibitors (SSRI), used primarily as anti-depressants, are known to have limited efficacy. As a result, SJX-653 has the potential to address the high unmet medical need for a safe and effective non-hormonal therapy for menopausal VMS.

Highlighting the size of the menopausal VMS market opportunity, products containing conjugated estrogens, a form of hormone therapy indicated for the treatment of menopausal VMS, accounted for the largest number of prescriptions of all drugs sold in the United States in 2000. Following the 2002 publication of results from the Women's Health Initiative clinical study describing hormone therapy safety risks, approximately 65% of women taking hormones stopped therapy.

Vasomotor symptoms are also a common and sometimes debilitating side effect of certain cancer treatments, including tamoxifen or aromatase inhibitors used for breast cancer in women and androgen deprivation therapy used for prostate cancer in men. These agents can induce an abrupt onset of vasomotor symptoms, making it challenging for patients to adhere to their cancer treatment. Addressing drug-induced VMS in this setting represents another potential development opportunity for SJX-653.

About Sojournix

Sojournix is a clinical stage biopharmaceutical company focused on developing and commercializing novel therapies for the treatment of women's health and neuroendocrine disorders. We are advancing SJX-653, a novel and selective NK3 antagonist in clinical development as a once-daily non-hormonal therapy for moderate to severe vasomotor symptoms (commonly called "hot flashes") due to menopause. To learn more about Sojournix, we welcome you to visit www.soujournixpharma.com.


Source: Sojournix

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