Polycystic Ovarian Syndrome.
TTX336-PCOS
| Product | Target & MOA | Indication | Preclinical | Ph.1 | Ph.2a | Ph.2b | Ph.3 | NDA Filing | NDA Approval | Milestones |
|---|---|---|---|---|---|---|---|---|---|---|
| Polycystic Ovarian Syndrome (PCOS) | ||||||||||
| TTX336 | SARM Best-in-Class | PCOS | IND filing Ph. 2A Q1’2026 | |||||||
Endometriosis is a chronic, debilitating and painful disease that affects more than 10 percent of women during their reproductive years and can make it challenging to get pregnant. It occurs when tissue that is supposed to line the uterus is found in other places, usually throughout the pelvis.
Endometriosis is a chronic, debilitating and painful disease that affects more than 10 percent of
women during their reproductive years and can make it challenging to get pregnant. It occurs when
tissue that is supposed to line the uterus is found in other places, usually throughout the pelvis.
The Challenge of PCOS
1. Inconsistent and Delayed Diagnosis
PCOS presents with diverse symptoms, from irregular cycles and infertility to insulin resistance and inflammation. No single definitive diagnostic test exists, and clinical criteria vary across regions, leading to underdiagnosis and misdiagnosis. Many women face years of uncertainty before receiving appropriate care.
2. Symptom Control Without Disease Modification
Current therapies manage symptoms—using hormones, insulin sensitizers, or lifestyle changes—but do not address the root biological drivers of the condition. PCOS remains a chronic, lifelong disorder without targeted or disease-modifying treatment options.
3. Limited Understanding of Underlying Biology
PCOS reflects a complex interplay of hormonal imbalance, immune dysregulation, and metabolic dysfunction, yet its molecular mechanisms are poorly defined. This limits the discovery of predictive biomarkers and novel therapeutic targets, slowing progress in precision medicine.
Temple Therapeutics is addressing these challenges head-on.
Through a co-development agreement with a mid tier pharma, Temple is advancing a novel disease-modifying molecule into clinical testing. Further, Temple plans to integrate its biobank and AI-driven analytical platforms, to further map the molecular signatures that define PCOS—laying the groundwork for non-hormonal, mechanism-based diagnostics and therapeutics that can restore biological balance and improve long-term outcomes for women.
- Exceptionally painful menstrual cramps
- Pain during or after sex
- Persistent pain in the lower back and pelvis
- GI problems, especially during menstrual periods
- Infertility
Common Symptoms Include
- Exceptionally painful menstrual cramps
- Persistent pain in the lower back and pelvis
- Pain during or after sex
- GI problems, especially during menstrual periods
- Infertility
For those with endometriosis, pain often worsens during menstrual periods because endometrial tissue outside the uterus can grow and bleed in sync with a menstrual period. This causes pain because the swelling and blood can’t easily exit the body as menstrual blood can.
Anyone with a uterus can develop endometriosis, but women in their 30s and 40s are particularly impacted. Women who have never had children and those with a family member who has endometriosis are more likely to develop this health problem.
Scientists don’t know what triggers endometriosis. Some possible causes include blockages that prevent menstrual blood from leaving the body, genetics, problems with the immune system that prevent it from inhibiting the growth of endometrial tissue in places where it doesn’t belong, and hormonal imbalances.
Changing the paradigm.
Temple Therapeutics is seeking to change the ways in which endometriosis is both detected and treated.
The current procedure for diagnosis involves laparoscopic surgery using a tiny camera inserted through a small incision, which can be inaccurate and lead to complications. Temple is pioneering an entirely new diagnostic method: the first non-invasive alternative to surgical diagnosis.
This approach will allow for safer, easier, and more accurate confirmation of disease, reducing the financial, physical, and emotional burden on patients and their communities. We are also seeking to improve the available therapies by developing a drug to treat endometriosis.
To bolster our endometriosis work, we are creating a global platform for dialogue among endometriosis patients, their communities, healthcare providers, and scientific experts, building an evidence-based culture of education and support for those suffering from this disease.
10%
Endometriosis affects an estimated 2 to 10 percent of American women of childbearing age.
TTX334Dx for early detection.
Our researchers are developing a panel of biomarkers, TTX334Dx, that has shown an ability in early trials to detect endometriosis with a high level of sensitivity and specificity. These biomarkers, or molecules in the blood, allow earlier detection, identifying disease before it progresses to a more complex stage.
This approach decreases the risk of misdiagnosis and its accompanying complications, while also helping manage the disease by assessing the efficacy of other potential therapies. Temple anticipates launching this diagnostic test in 2023.
TTX334e for early treatment.
We are also developing a drug, TTX334e, intended to treat endometriosis. The drug is currently in preclinical stages. Unlike existing treatments, which include painkillers, surgeries, and hormonal drugs, TTX334e acts by killing fibrotic cells, attacking the root cause of the disease rather than attempting to just mitigate symptoms. We anticipate launching a Phase 1 trial of the drug in 2023.
