Dilafor presents top line result from a Phase IIb study in tafoxiparin
STOCKHOLM, SWEDEN– November 1, 2018. Dilafor AB, announces today top line results from a Phase IIb study in tafoxiparin. The primary endpoint of the study - reducing time to vaginal delivery, defined as time from start of tafoxiparin treatment until delivery - was not met.
Dilafor today presents results from a Phase IIb‑study in tafoxiparin ‑ a drug candidate that targets the problem of protracted labor in a completely new way compared to treatments available today. In the study, 360 women were randomly divided into one of four treatment arms, either in one of three treatment arms with different doses of tafoxiparin or in a placebo arm. In the active dose groups the women were administered a low, medium or high dose of tafoxiparin in combination with the standard treatment for protracted labor – oxytocin.
Tafoxiparin was well tolerated amongst both women and children, but no statistically significant efficacy was observed in any of the dose levels studied. A full review of the drug candidate’s safety profile will be presented as soon as all patients have completed a follow‑up period.
“The area of protracted labor has for a long time been overlooked – the standard treatment, oxytocin, was introduced already in the 50’s. Even with this setback in the development of tafoxiparin it is important that we continue to work towards reducing the labor‑related complications that arise in connection with protracted labor”, says Gunvor Ekman Ordeberg, CMO and co-founder of Dilafor.
The full results from the study will be published in a scientific journal or at a medical congress at a later stage.
For further information, please contact:
Lena Degling Wikingsson, CEO at Dilafor AB
Phone: +46 (0)70 790 02 07,
TO THE EDITORS
About Dilafor AB
Dilafor AB is a Swedish drug development company focusing on the development of tafoxiparin for obstetric indications. The company’s primary goal is to decrease the incidence of slow progress of labor both after induction of labor and after spontaneous onset of labor. The main owner of Dilafor is KDev Investments AB, which is jointly owned by Karolinska Development AB (publ) and Rosetta Capital IV. The other main owners are The Foundation for Baltic and European Studies (Östersjöstiftelsen) and Praktikerinvest. For more information, please visit: www.dilafor.com.
Tafoxiparin is a proprietary polysaccharide based drug developed by Dilafor. Women that experience protracted and complicated labor have deficiency in a naturally occurring submucosal molecule that plays an important role in labor. Preclinical and clinical data show that tafoxiparin fulfills the role of this molecule and works in conjunction with naturally occurring molecules important in child birth.
Slow progress of labor has an incidence of approximately 40 per cent of all pregnant women and can cause complications both during and after the labor for both the mother and child.
Examples of maternal complications are emergency caesarean sections, postpartum hemorrhages, vaginal tears, anal ruptures and an increased risk of infection in the uterus after the labor. Slow progress of labor creates a tension on the fetus and can cause lower oxygenation of the fetus but also an increased risk of an infection in the child. These complications lead to short and long term consequences for the mother and the newborn in addition to substantial health care costs.
Dilafor initiates phase IIb clinical trial with tafoxiparin in women with slow progress of labor
STOCKHOLM, SWEDEN – January 4 , 2017. Dilafor AB, a drug development company focusing on the development of tafoxiparin for obstetric indications, today announces that the first subject has been enrolled in the Phase IIb study with tafoxiparin in pregnant women who experience slow progress of labor or labor arrest after spontaneous onset.
Tafoxiparin is in clinical development as a new treatment designed to decrease the incidence of protracted labor (i.e labor that lasts more than 12 hours), which is the main cause of emergency surgical deliveries such as caesarian section. The condition is often associated with complications for both mother and child.Tafoxiparin has shown in a Phase II clinical trial encouraging evidence that it can decrease the proportion of women with labor more than 12 hours.
The Phase IIb study is a multi-center, double blind, placebo-controlled dose-finding study in term-pregnant first-time mothers that after spontaneous onset of labor require labor augmentation due to primary slow progress or labor arrest. The pregnant women will be randomized to receive one of three different dosages of tafoxiparin or placebo. The treatment will be as an adjunct to standard of care, which is intravenous infusion of oxytocin. The target is to enroll 360 pregnant women in the Phase IIb study.
This proof of concept study is designed to demonstrate reduced time to vaginal delivery defined as time from start of tafoxiparin treatment until delivery. Secondary endpoints include safety, proportion of women with labor time more than 12 hours, number of women with instrumental deliveries such as vacuum extraction and number of caesarian sections. The study is planned to be performed in two countries in Europe including up to 14 delivery clinics. Sweden is the first country to be included.
Lena Degling Wikingsson, CEO of Dilafor, said: “We are excited to initiate this proof of concept study with tafoxiparin in this important indication. The only option for pregnant women who experience protracted labor and do not respond to current clinical practice is acute caesarian sections, which are often associated with complications for both mother and child. We have already seen encouraging results in a completed clinical study with tafoxiparin and look forward to the results of this new trial, which if positive, will pave the way for a pivotal trial and potentially a new treatment option for patients.”
Gunvor Ekman-Ordeberg, CMO and co-founder of Dilafor, said: “I am delighted that my 40 years’ preclinical and clinical research within obstetrics have reached this significant milestone. There is a great medical need for new treatments to address protracted labor and I hope that tafoxiparin will make a difference for all these pregnant women.”
Dilafor announces patent grant in the U.S. for its Phase II development drug tafoxiparin
STOCKHOLM, SWEDEN – December 2 , 2016. Dilafor AB, a drug development company focusing on the development of tafoxiparin for obstetric indications, today announced it has been granted a U.S. patent protecting its proprietary compound tafoxiparin.
Tafoxiparin is in clinical development as a new treatment designed to decrease the incidence of protracted labor both after induction of labor and after spontaneous onset of labor. Protracted labor (i.e labor that lastsmore than 12 hours) is the main cause of emergency surgical deliveries, such as caesarian section. The condition is often associated with complications for both mother and child. Tafoxiparin has shown in a Phase II clinical trial encouraging evidence that it can decrease the proportion of women with labor more than 12hours.
The U.S. patent granted by the United States Patent and Trademark Office (USPTO) provides key intellectualproperty protection in the U.S. for Dilafor’s proprietary development compound tafoxiparin until at least April 2033, with the possibility of up to five years’ additional patent term extension. In addition to compound protection, claims have also been granted in the U.S. to a manufacturing method as well as to a number of medical uses of tafoxiparin. Patent applications in a broad range of additional territories including Europe, Asia and Latin America, are pending.
Lena Degling Wikingsson, CEO of Dilafor, said: “The grant of this U.S. patent is a major milestone for Dilafor and the result of a focused IP strategy within Dilafor to build a comprehensive patent estate around our lead product. The patent will be an essential IP asset for tafoxiparin and its potential use in treating different important obstetrical indications with high unmet medical need.”
Dilafor recently announced the successful completion of a SEK 51 million financing round, which will enable the company to facilitate a Phase IIb dose finding trial with tafoxiparin in Northern Europe, planned to start before the year end 2016. The study will include women with slow progress of labor after a spontaneous onset.
Dilafor raises SEK 51 million to facilitate Phase IIb clinical study with tafoxiparin
STOCKHOLM, SWEDEN – September 27, 2016. Dilafor AB, a drug development company focusing on the development of tafoxiparin for obstetric indications, today announced it has successfully completed a financing round raising SEK 51 million (US$5.9 million) from new and existing investors. The new financing round was led by Lee's Healthcare Industry Fund and Rosetta Capital, and the syndicate included Östersjöstiftelsen, Praktikerinvest PE AB, Pila AB and Dilafor’s largest existing shareholder, KDev Investments, an investment fund jointly owned by Karolinska Development (Nasdaq Stockholm: KDEV) and Rosetta Capital.
Dilafor’s lead candidate, tafoxiparin, a modified form of heparin, is in clinical development to decrease theincidence of protracted labor both after induction of labor and after spontaneous onset of labor. Protractedlabor (i.e labor that lasts more than 12 hours) is the main cause of emergency surgical deliveries, such ascaesarian section. The condition is often associated with complications for both mother and child.Tafoxiparin has shown in a Phase II clinical trial encouraging evidence that it can shorten labor time.
The successful completion of the financing round enables Dilafor to facilitate a Phase IIb dose finding trial with tafoxiparin trial in Northern Europe, which is planned to start before the year end 2016. The study will include women with slow progress of labor after a spontaneous onset.
Lena Degling Wikingsson, CEO of Dilafor, said: “This planned clinical study is an important event in the clinical development program for tafoxiparin. There is no available treatment today to help these women that have high risk of fetal and maternal complications as a consequence of slow progress and protracted labor. With support of long-term investors, Dilafor has now secured the financial resources needed to reach this next crucial milestone in the development of this promising candidate, and to identify a dose to takeforward into the final stages of clinical development.”
Jason Chow, CFO of Lee’s Healthcare Industry Fund, said: “"We are delighted to strengthen our partnership with Dilafor by becoming a shareholder as well. Woman Health is one of our focused areas and we look forward to the advancement of Dilafor's lead program Tafoxiparin into the final stages of clinical development."
Dr. Torsten Goesch, Director of Rosetta Capital, said: “ There is a strong medical need within the women health area targeted by Tafoxiparin and we are excited to support the company to reach this important milestone in the clinical development of the product”
Dilafor announces positive results from a multi dosing safety and pharmacokinetic clinical study.
STOCKHOLM, SWEDEN – February 5, 2015. Dilafor AB announced today completion of a safety and pharmacokinetic multi dosing phase I study with their lead product tafoxiparin. The purpose of the study was to evaluate different clinical administration routes and different dose levels of tafoxiparin in healthy female volunteers. The results will give guidance on the dosages to be used in the phase II trial in Asia in Labor induction expected to start in end year 2015. Dilafor is a Karolinska Development portfolio company.
The phase I study was focused on the evaluation of the safety and pharmacokinetics of tafoxiparin using amultidosing schedule of tafoxiparin. The study demonstrated tafoxiparin to be safe and well tolerated and with a predictive pharmacokinetic profile. The outcome of the study will be used in the planning of the global clinical trial program in two major indications; Labor induction and Labor arrest. As a next step and aspart of the clinical development program in Asia together with Lee’s Pharmaceuticals, tafoxiparin will beused in a phase II clinical trial in pregnant women that are induced into labor. Initiation of the study is expected in end of 2015. Decision on the study start is depending on approval from Chinese FDA. Meanwhile during 2015, a phase I clinical safety study is planned in Asian women to support the start of the phase II study and to support the use of Asian clinical data in global clinical development.
Including this study, tafoxiparin has been used and shown to be safe in totally three clinical trials involving 335 subjects of whom 263 were term pregnant women.
“This study is an important milestone in the clinical strategy for development of tafoxiparin for obstetricalindications. The generated pharmacokinetic data and the supportive safety data give us excellent tools todecide about the design of the phase II clinical trial” says Lena Degling Wikingsson, CEO at Dilafor AB
Dilafor signs supply and partnership agreement with Opocrin
STOCKHOLM, SWEDEN and MODENA, ITALY – October 8, 2014. Dilafor AB and Opocrin S.p.A. announced today that they have entered into a commercial supply and partnership agreement. In the agreement, Opocrin will concurrently make an investment in Dilafor and be appointed as the main commercial manufacturing partner for Dilafor’s candidate drug tafoxiparin for the European, US, CIS and Japanese markets. Furthermore, Opocrin will supply manufacturing services during clinical development of tafoxiparin and the companies will jointly develop the commercial manufacturing of tafoxiparin. Opocrin is one of the most experienced European manufacturers of polysaccharides, such as low molecular weight heparins. Dilafor is a Karolinska Development portfolio company.
The partnership will initially focus on the clinical supply of tafoxiparin in support of the Phase II and Phase III clinical trial program in obstetrical indications. Opocrin will support the company with services and manufacturing needed to take tafoxiparin through those clinical studies and by preparing for the commercial supply of tafoxiparin for major markets such as US, EU, Japan and CIS.
Further details on the investment and the terms of the agreement are not being disclosed.
“We are looking forward working together with Opocrin in this exciting and important phase in the development of tafoxiparin. Opocrin has extensive experience in the manufacturing of polysaccharide derivatives such as tafoxiparin making them an excellent commercial partner for Dilafor” says Lena DeglingWikingsson, CEO at Dilafor AB
"We are excited to work with Dilafor and to support them as manufacturing partner of tafoxiparin. The candidate drug addresses important medical needs and has potential to improve delivery which leads to better fetal and maternal health", says Giulia Falcone, Managing Director of Opocrin S.p.A.
Dilafor enters into a license and partnership agreement with Lee’s Pharmaceutical
STOCKHOLM and HONG KONG - February 20, 2014. Dilafor AB, part of Karolinska Development’s portfolio of companies, based in Stockholm, Sweden and Lee’s Pharmaceutical Holdings Ltd, based in Hong Kong announced today that they have entered into a license agreement. According to the agreement, Dilafor grants to Lee’s Pharmaceutical the right to manufacture, develop and commercialize tafoxiparin for obstetrics and gynecological indications in China, Hong Kong, Macau and Taiwan.
Pursuant to the terms of the agreement, Dilafor and Lee’s Pharmaceutical will jointly developtafoxiparin for obstetrical and gynecological indications. The joint clinical development program of tafoxiparin will initially be focused on reducing labor times for patients who do not start labor spontaneously and are induced into labor, an indication where both Dilafor and Lee's Pharmaceuticalsee a major medical need for the product in terms of improving outcomes for both mother and baby.
Dilafor will receive an upfront payment as well as future development and sales milestones plus royalties on sales of the product which will be manufactured and sold by Lee’s Pharmaceutical in China, Hong Kong, Macau and Taiwan. Lee’s Pharmaceutical will conduct and finance Phase II andPhase III trials in China, so that the results can be used as the basis for additional development outsidethe countries where Lee’s Pharmaceutical has its license. Further details on the terms of the agreement are not being disclosed.
“We are looking forward to working together with Lee’s Pharmaceutical and to take tafoxiparin into further clinical development”, says Lena Degling Wikingsson, CEO at Dilafor AB
In addition to the labor induction indication, tafoxiparin is intended to be used for the treatment oflabor arrest. Tafoxiparin has previously been tested in a randomized, double-blind and placebo controlled Phase II trial conducted in Sweden which included 263 pregnant women. The study showed promising results forming the basis for the continuous clinical development.
"We are excited to work with Dilafor to expand the clinical development of tafoxiparin into China.With nearly 20 million babies born each year, China has significant unmet medical needs in maternal health. It is our intention to leverage our available resources to accelerate the development of tafoxiparin in China", says Dr. Benjamin Li, founder and CEO of Lee’s Pharmaceutical.
“We are very pleased with this license agreement with Lee’s Pharmaceutical. We believe Lee’s Pharmaceutical will be an excellent partner for Dilafor in the further development and commercialization of tafoxiparin. Through KDev Investments AB, we own 49% of Dilafor and this agreement will add value to potential future deals covering all other markets outside China, HongKong, Macau and Taiwan”, says Torbjörn Bjerke, CEO of Karolinska Development.
“I am delighted that my 40 years’ preclinical and clinical research have reached this significant milestone. There is a great medical need for new treatments to address protracted labor and I hope that tafoxiparin will make a difference for all these pregnant women.”
Professor Gunvor Ekman Ordeberg, Founder and CMO at start of phase IIb