Q-122 is an orally bioavailable, non-hormonal, small molecule that is being developed by QUE Oncology as a treatment for vasomotor symptoms (VMS; also known as hot flashes and night sweats) in postmenopausal women, and in cancer patients receiving hormone therapy.

Promising clinical activity and an excellent safety profile of Q-122 has been demonstrated in early clinical trials of healthy volunteers, cancer patients, and breast cancer survivors taking endocrine therapy who were experiencing VMS (over 125 total subjects). QUE has recently completed a randomized, double-blind, placebo-controlled Phase 2 trial for the treatment of hot flashes in breast cancer patients across Australia, New Zealand, and the US. The clinical results warrant further development of Q-122.

Functionally in preclinical studies, Q-122 reduces the frequency of kisspeptin-neurokinin-dynorphin (KNDy) neuron activation events, which represent the activity of the gonadotropin-releasing hormone (GnRH) pulse generator that controls reproductive hormone secretion and is believed to be a key thermoregulatory control center in the brain. Importantly, Q-122 exhibits a novel mechanism of action – it is not an NK3 receptor antagonist.

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Menopause and Vasomotor Symptoms 

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Over 75% of women experience VMS in association with menopause. Women may experience VMS earlier in midlife, before the onset of menstrual cycle changes, and well into their 60’s and 70’s, decades after the menopause transition. The severity of VMS is clinically defined on a scale: mild, sensation of heat without sweating; moderate, sensation of heat with sweating and able to continue activity; and severe, sensation of heat with sweating and causing cessation of activity. Moderate and severe hot flashes experienced by women significantly impair quality of life and most women will seek medical treatment.

Menopausal hormone therapy remains the gold standard treatment for menopausal hot flashes; however, many women have health conditions that are strong contraindications to hormone therapy. There is an urgent need for a non-hormonal therapy for the effective relief of VMS.

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Breast Cancer Patients/Survivors and Vasomotor Symptoms

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Similarly to postmenopausal women, VMS present a major health problem in breast cancer survivors with significant negative impacts on quality of life, sleep, and medication compliance. In breast cancer survivors who receive estrogen deprivation therapy (such as tamoxifen and aromatase inhibitors), VMS affects approximately 65 – 95% of patients. VMS is commonly more severe in breast cancer survivors taking estrogen deprivation therapy than those experienced by postmenopausal women. Furthermore, the persistence and severity of VMS represent a major cause of nonadherence and/or discontinuation of therapy. 

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Treatment options for VMS are limited in breast cancer patients/survivors. Hormone replacement therapy is contraindicated in breast cancer survivors because of an increased risk of disease recurrence. The only non-hormonal treatment approved for treating VMS has the potential to interfere with tamoxifen metabolism and therefore may reduce the effectiveness of tamoxifen in breast cancer patients. While many other compounds have been tested, none have been approved for use in breast cancer survivors by regulatory authorities. The treatment of VMS in breast cancer survivors is a significant unmet medical need.

 

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Prostate Cancer Patients/Survivors and Vasomotor Symptoms

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Approximately 80% of men who receive androgen deprivation therapy for the treatment of prostate cancer report VMS. Most prostate cancer patients who experience VMS have the same frequency and duration throughout the course of treatment as when the treatment started. Some men choose to discontinue their androgen deprivation therapy due to debilitating, persisting hot flashes. With the increasing number of men with prostate cancer and lifelong treatment with androgen deprivation therapy, often accompanied by VMS, the demand for effective treatments is rising.

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 High Unmet Need for the Treatment of Vasomotor Symptoms