JNP-0301 is a natural progesterone IVR in development for the prevention of preterm birth in women with a short cervical length at mid-pregnancy.
Globally, 15 million babies are born before 37 weeks gestation each year, and one million will die. In the U.S., approximately 10% of the 4 million births annually are preterm. The average medical cost for a premature baby is over $50,000, more than ten times that of a healthy infant.
The cervix is a cylinder-shaped neck of tissue that connects the vagina and uterus. Located at the lowermost portion of the uterus, the cervix is composed primarily of fibromuscular tissue. As a pregnancy advances, the cervix progressively shortens and thins to permit the infant’s birth.
In a typical pregnancy, the average cervical length at 24 weeks gestation is 35 mm. A short cervical length at mid-pregnancy is the strongest indicator of a pregnant woman’s risk of preterm birth. When cervical length is less than 22 mm, women face a 20% probability of preterm birth (PTB)viii.
Clinical data strongly support use of vaginal progesterone for prevention of PTB.i, ii, iii Additionally, there is clear consensus that vaginal progesterone should be used for prevention of PTB in women with a short cervical length at mid-pregnancy. iv,v,vi
The Society for Maternal-Fetal Medicine (SMFM) recommends screening women with no history of prior spontaneous PTB for short cervical length at 18 to 24 weeks gestation. In women with singleton gestations, no prior history of PTB, and cervical length measuring less than or equal to 20mm at ≤24 weeks, SMFM advocates daily administration of vaginal progesterone from time of diagnosis to 36 weeks gestation.v
There are currently no FDA-approved drugs, vaginal progesterone or otherwise, to treat women at risk of PTB due to short cervical length.
JNP-0301 is designed for continuous, consistent local delivery of natural progesterone. We believe this candidate may offer an important therapeutic option for women at risk for PTB due to a short cervix at mid-pregnancy.
In 2017, we plan to conduct definitive sheep studies to test the actual size and configuration of the rings in an animal model, where results are then translatable to humans. We will also continue our IND-enabling activities, all of which could support a potential investigational new drug (IND) application submission with the FDA for JNP-0301 in the first half of 2018.
[i] Fonseca EB, Celik E et al. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 2007; 357:462-9..
[ii] Hassan SS, Romero R et al. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 2011; 38-18-31.
[iii] Maher MA et al., Prevention of preterm birth: a randomized trial of vaginal compared with intramuscular progesterone. Acta Obstet Gynecol Scand 2012; 91:DOI: 10.1111/aogs.12017.
[iv] Medicaid Health Plans of America. Preterm Birth Prevention: Evidence-Based Use of Progesterone Treatment Issue Brief and Action Steps for Medicaid Health Plans, November 2014.
[v] Society for Maternal-Fetal Medicine. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. American Journal of Obstetrics & Gynecology, Volume 206 , Issue 5 , 376 – 386. (Access SMFM summary.)
[vi] American Congress of Obstetrics and Gynecology. Practice Bulletin No. 130: Prediction and Prevention of Preterm Birth Obstet Gynecol 2012;120: 964–73. Affirmed 2016.
[vii] Iams JD, Goldenberg RL, et al. The length of the cervix and the risk of spontaneous premature delivery. N Engl J Med, 1996; 334: 567–572.