LPCN 1107

LPCN 1107

Oral Product Candidate being Developed For The Prevention Of Recurrent Pre-Term Birth

Parenting and new life concept. Mother holding newborn baby boy

Reducing
Pre-Term Births

LPCN 1107 is an oral product candidate of 17-alpha-hydroxyprogesterone caproate (HPC) under development for the indication of prevention of recurrent preterm birth. LPCN 1107 has the potential to become the first oral HPC product for the prevention of preterm birth in women with a prior history of at least one preterm birth. Potential benefits of our oral product candidate relative to current injectable products include the elimination of pain and site reactions associated with weekly injections, elimination of weekly doctor visits or visits from the nurse, and elimination of interference/disruption of personal, family or professional activities associated with weekly visits.

Market Overview Of Pre-Term Birth

Preterm Birth (PTB) is defined as delivery of less than 37 weeks of gestation. PTB occurs in ~12% of all US births. PTB remains the leading cause of perinatal mortality and morbidity, accounting for as many as 75% of perinatal deaths.

The expense associated with PTB involves not only the immediate cost of the preterm baby being treated in the hospital ICU setting, but includes the long-term treatment costs for disabilities for the life of the child. Current total PTB related economic impact on the US health system far exceeds $26 billion, an estimated cost in 2006.

5020

Behrman RE et al. in: Behrman RE, Butler AS, eds. Preterm Birth: Causes, Consequences, and Prevention. Washington, DC: The National Academies Press; 2006:329-354.

There is a significant unmet need for a ‘patient friendly’ product for the prevention of PTB. The only FDA approved the product for the prevention of PTB must be given by either a sub-cutaneous or intra-muscular injection each week for a total of 18-22 injections.

LPCN 1107 Attributes

Taken Orally Twice A Day

Designed for oral administration twice daily of hydroxyprogesterone caproate (same active as in the only FDA approved injectable product for the prevention of recurrent PTB)

No More Injections

Eliminates site reaction and pain at the site of injection

Fewer Doctors Visits

Eliminates regular doctor office visits or visits from the nurse (weekly visits for 18 – 22 weeks)

Higher Absorption Rate

Significant absorption upon oral dosing of LPCN 1107 in healthy non-pregnant women

Excellent Response In Trials

Good dose response demonstrated in healthy non-pregnant women

Well Received In Single Dose Study

LPCN 1107 was well tolerated in single dose study

Orphan Drug Designation

LPCN 1107 has received orphan drug designation - meaning it is an agent developed to treat a condition that affects fewer than 200,000 people in the US.

Innovative Pharmaceutical Products

ENHANCING HEALTH & IMPROVING PATIENT COMPLIANCE

Scroll to Top