LPCN 1107 – Prevention of Preterm Birth
Strong pharmaco-economic justification
Compelling efficacy rationale
Preventing neonatal complications
Product Candidate: LPCN 1107
Evidence-Driven Response to the Preterm Birth Health Crisis
Product Attributes:
LPCN 1107 is an oral therapy option comprising 17-alpha-hydroxyprogesterone caproate (HPC) for the prevention of recurrent preterm birth.
Poorly water-soluble 17-alpha-hydroxyprogesterone caproate (HPC) is an ester of endogenous hydroxyprogesterone, a progestogen with no androgenic/anti-androgenic or estrogenic activity. HPC is not prone to CNS side effects from GABAA-modulating metabolites. HPC safety is well characterized with 2000+ patients in previous trials, decades of clinical use, and literature safety reports at higher doses.
Our success-focused clinical design is based on available HPC efficacy data directed to improving neonatal composite index (NCI), a medically relevant outcome and the most responsive endpoint, in target population with higher risk of PTB.
About Indication:
PTB is when an infant is born prior to 37 weeks, with early PTB being <35 weeks.
- Globally, the rate of PTB ranges from 5% to 18% of babies born each year and PTB occurs in ~11% of all US births. Roughly 1 million children younger than 5 years of age die each year due to PTB complications.
- Approximately 278,000 women have spontaneous PTB annually and approximately 182,000 are considered “High-Risk” PTB (<35 weeks) patients.
- A history of spontaneous PTB increases the risk of recurrent PTB by 4-8 times.
Infants born too early have higher rates of death and disability. PTB and low birth weight accounted for ~ 16% of infant deaths (deaths before 1 year of age). Babies who survive PTB could have short- and long-term health complications.
No FDA approved product is available for prevention of PTB. No treatment candidates are known to be in an advanced stage of development. There is a significant unmet need for a reliable ‘patient friendly’ oral product for the prevention of PTB.
Not only can PTBs take a significant emotional toll on families, the financial burden associated with PTB can be overwhelming, with not only the immediate cost of the preterm baby being cared for in the hospital NICU setting, but also potential disabilities and long-term treatment costs over the life of the child.
PTB is a health crisis in the US and globally and is estimated to cost the US healthcare system >$25B annually.
Due to the high unmet medical need, the FDA has granted orphan drug designation to LPCN 1107 based on a major contribution to patient care.