CASE STUDY – Bionorica
Evaluating the Spasmolytic Effects of BNO 1095: A Promising, Herbal Candidate for Treatment of Primary Dysmenorrhea
REPROCELL supported Bionorica in advancing BNO 1095, a plant-based treatment for primary dysmenorrhea, through human tissue studies demonstrating its spasmolytic effects.
For many women, menstrual cramps associated with primary dysmenorrhea can be debilitating, severely impacting their daily lives. Unlike secondary dysmenorrhea, which is caused by an underlying condition such as endometriosis, primary dysmenorrhea occurs without a medically identifiable disease state. The pain is believed to result from intense uterine contractions driven by prostaglandins, leukotrienes, and inflammatory cell infiltration during the breakdown of the endometrial lining.
While standardized extracts of Vitex agnus-castus (VAC), commonly known as chaste berry, have been clinically effective in alleviating premenstrual syndrome (PMS) symptoms, their precise mechanisms of action remain largely unknown. Recognizing the potential of VAC extracts in treating primary dysmenorrhea, Bionorica developed BNO 1095, an herbal dry extract already marketed under the name Agnucaston® for PMS. Now, the company is seeking regulatory approval for the treatment of primary dysmenorrhea and advancing their active pharmaceutical ingredient (API) through Phase III clinical trials.
Study Overview
To support the approval process, Bionorica collaborated with Reprocell to evaluate the efficacy of BNO 1095 in human isolated myometrial strips. Using our in vitro organ bath model, we conducted rigorous testing on fresh human uterine tissues to assess the spasmolytic properties of BNO 1095.
Methods
Fresh human uterine tissues were exposed to oxytocin followed by a concentration response curve to BNO 1095 to assess its spasmolytic properties.
Figure 1
Concentration-dependent anti-convulsive effect of BNO 1095 on human uterine strips. Relaxation of 200 nM (0.2 μg/ml) oxytocin-induced contractions of isolated human uterus specimens through BNO 1095. Up to 0.5 % ethanol was present in the vehicle control. Data are given as means ± SEM, n = 5 (Röhrl et al., 2016).
The findings demonstrated that BNO 1095 effectively inhibits contractions induced by oxytocin in fresh human isolated uterine tissues in a dose dependent manner and it was found to be significantly different to the vehicle group.
This data was published by Bionorica in Clinical Phytoscience Journal (Röhrl et al., 2016) along with data collected from other in vivo and in vitro studies providing evidence that BNO 1095 effectively treats menstruation-related complaints including primary dysmenorrhea. The human data generated at Reprocell provided evidence to translate the findings from the animal studies to the clinical target population.
Study Conclusion and Impact
The results provided additional evidence that BNO 1095 may be a promising candidate for treating primary dysmenorrhea. By demonstrating the extract’s ability to suppress uterine hyper-contractility, this study supports Bionorica’s efforts to expand the clinical indications for Agnucaston®. With the API now in a Phase III trial for primary dysmenorrhea, if successful regulatory approval could provide women with a novel, plant-based treatment option to alleviate menstrual pain safely and effectively.
At Reprocell, we are proud to have contributed to this critical research, leveraging our expertise in human tissue testing to generate meaningful, translational data. Our collaboration with Bionorica underscores the potential of evidence-based herbal medicine in addressing significant unmet medical needs in women’s health.
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References
- Röhrl, J., Werz, O., Ammendola, A. et al.Vitex agnus-castus dry extract BNO 1095 (Agnucaston®) inhibits uterine hyper-contractions and inflammation in experimental models for primary dysmenorrhea. Clin Phytosci 2, 20 (2016). https://doi.org/10.1186/s40816-016-0034-3