Data presented in the poster, titled"Assessing screening and treatment patterns for short cervical length (SCL) in pregnancy" (Program ID No. 403), describe the practice among a balanced sample of physicians across nine geographic regions in the U.S. Of the 500 participating physicians, 91 percent were OB/GYNs, gynecologists, or obstetricians; 6 percent were maternal-fetal medicine specialists; 3 percent were other specialty physicians. All participants were 25 years of age or older with primary practices in the U.S. who actively see adult pregnant patients with a mid-trimester diagnosis of SCL.
For pregnant women with sonographic short cervix and no history of spontaneous PTB, U.S. clinical guidelines recommend use of vaginal progesteronei,ii. However, there are no vaginal progesterone products approved by the
SCL is a strong predictor of PTB, and PTB is a major contributor to infant mortality in the U.S. The estimated prevalence of pregnant women with SCL less than or equal to 25mm is approximately 400,000.iii
"This study offers us valuable insight on how physicians are combatting preterm birth in their practices, and demonstrates that greater access to an optimized vaginal progesterone therapy to treat women with short cervical length to prevent preterm birth is needed," said
Juniper is developing an investigational progesterone intravaginal ring, JNP-0301, for sustained delivery of natural progesterone to treat women with SCL who are at risk of delivering before 37 weeks gestation. Prototype formulation development is underway, with definitive sheep studies to be initiated by the end of 2017. An Investigational New Drug (IND) submission is planned for the first half of 2018.
The poster is now available online. The related abstract is included in
About Short Cervical Length in Pregnancy
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 pregnancy advances, the cervix progressively shortens and thins to permit birth.
In a typical pregnancy, the average cervical length at 24 weeks gestation is 3.5 cm. 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 22mm, women face a 20 percent probability of preterm deliveryiii.
SMFM recommends screening women with no history of prior spontaneous preterm birth 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 or before 24 weeks gestation, SMFM advocates daily administration of vaginal progesterone from time of diagnosis to 36 weeks gestationi.
There are no FDA-approved drugs, vaginal progesterone or otherwise, to treat women at risk of preterm birth due to short cervical length.
About Preterm Birth
Preterm birth is defined as delivery before 37 weeks gestation. Globally, 15 million babies are born prematurely each year, and approximately one million die as a result of preterm birth complications. The average medical cost for a premature baby is over
About Juniper Pharmaceuticals
Juniper Pharmaceuticals™ is a trademark of
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Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the anticipated clinical program for JNP-0301, the expected timing of planned IND-enabling sheep studies, the potential timing of an IND submission for JNP-0301, Juniper's ability to leverage the 505(b)(2) pathway for product candidates and the expectation that the core operating business will enable targeted product development investments. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the drug development process generally, including the timely completion of prototype development and planned IND-enabling and sheep studies; risks associated with the outcomes of the prototype formulation development efforts and planned IND-enabling and sheep studies and whether they support further development of JNP-0301 or our other product candidates; risks associated with the regulatory review process, including the risk that the
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iii 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.
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