Israel-based Gynica will dose the first patient in a Phase I trial of its cannabinoid-based therapies IntraVagS301 and IntraVagS302 for endometriosis by the end of this year.
CEO Yotam Hod told the Clinical Trials Arena that the candidates will help alleviate patients' symptoms of endometriosis, including chronic pelvic pain, dysmenorrhea (painful periods), and dyspareunia (painful intercourse).
The Phase I trial will test the safety, toxicity, and pharmacokinetics of the drugs that use microencapsulation technology, IntravagS301 and IntraVagS302. The study will last seven days.
The first patient on the trial will be dosed by the end of this year and the trial will enrol 24 patients with endometriosis, said Hod.
The two pharmaceutical-standard cannabinoid-based candidates, S301 and S302, are administered intravaginally to treat symptoms of endometriosis.
Gynica has also developed IntraVag, a proprietary microencapsulation technology designed for the controlled release of active pharmaceutical ingredients (API), allowing patients to self-dose vaginally.
The Phase I trial will be a blinded, single-centre, multiple-dose study led by Professor Felice Petraglia, a leading endometriosis expert, at Careggi University Hospital in Florence, Italy.
If Phase I is successful, the company will initiate a Phase IIa trial with both candidates in 2025. The Phase IIa trial will be a double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability, and efficacy of IntraVagS301 and IntraVagS302 for the treatment of endometriosis-associated symptoms.
Hod said that the company is investigating the possibility that IntraVagS301 and IntraVag302 could benefit patients with other gynaecological conditions.
The company also has a preclinical candidate being investigated for menopausal symptoms and other gynaecological conditions.
Endometriosis landscape
Endometriosis is a multifactorial condition that involves a combination of anatomical, hormonal, immunological, estrogenic, genetic, epigenetic, and environmental factors, with the exact cause still not fully understood.
As well as physical symptoms including pelvic pain, dysmenorrhea, dyspareunia, irregular uterine bleeding, and infertility, endometriosis is also associated with a range of psychiatric symptoms, including depression, anxiety, psychosocial stress, and a poor quality of life.
On 18 March, President Joe Biden signed an executive order to advance the study of health conditions specific to women and change the funding towards research.
