LEO Pharma files IND application to FDA for a clinical study of JW1601/LP0190 in the US
- Based on the successfully completed single-dose part of the phase I clinical trial in Korean population carried out by JW Pharmaceutical, LEO Pharma files IND application to the FDA for study of JW1601/LP0190 in US set to start in 2020.
Ballerup, Denmark, and Seoul, Korea, August 27th, 2019: LEO Pharma, a global leader in medical dermatology, and Korean JW Pharmaceutical today announced that LEO Pharma has filed an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a pharmacokinetics study in the US.
The filing is based on the two companies’ ongoing collaboration on the development of JW1601/LP0190, an oral treatment for atopic dermatitis for which JW Pharmaceutical out-licensed their investigatory drug to LEO Pharma in August 2018. JW Pharmaceutical has since January this year conducted phase 1 clinical trial consisting of a single dose and repeated dose studies in healthy adults. Recently the single dose phase for Koreans was successfully completed with acceptable safety and tolerability observed up to the highest dose, 5th cohort. Based on this trial LEO Pharma has now filed a protocol for a pharmacokinetics study in US – a small clinical trial with healthy volunteers to further evaluate the pharmacokinetics of JW016/LP0190.
“We are excited to see the progress of our collaboration with JW Pharmaceuticals that is now enabling us to file the IND application to the FDA and take the next step towards making an oral treatment for atopic dermatitis available. The unmet needs in this disease area are huge and an oral treatment will add substantially to the treatment options to the benefit of the many people living with this disease”, says Kim Kjoeller, Executive Vice President, Global Research & Development at LEO Pharma.
S.Y Lee, Senior Executive Vice President, Chief of Corporate Development Division said, “As the single-dose study for Koreans has been completed smoothly, LEO Pharma was able to apply for this study plan in US.” He also added that “JW Pharmaceutical will further strengthen our partnership with LEO Pharma in the future and develop JW1601 as a new drug for treatment of atopic dermatitis that will play a pivotal role in the global market.”
JW1601 is a H4R antagonist expected to have anti-pruritic and anti-inflammatory effect in atopic dermatitis. The new drug candidate is developed as an oral treatment, a more convenient route of administration with the potential to improve the compliance for the patient.
+45 3140 6180
LEO Pharma US
+1 973 637 8019
+1 862 337 0675
About LEO Pharma
About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 5,500 people, serving 76 million patients in 130 countries. In 2018, the company generated net sales of DKK 10,410 million.
About JW PHARMACEUTICAL CORPORATION
JW Pharmaceutical Corporation has been leading Korean medicine and medical supplies market over its 70 years of history. The company focuses on the field of research and development of anti-cancer drug and etc.; manufacture and sales of hospital fluid, antibiotic and other ethical pharmaceuticals.
JW Pharmaceutical Corporation was founded in 1945 and is listed on the Korea Exchange Market under the symbol "001060 ".
More information is available at http://www.jw-pharma.co.kr/pharma/en/main.jsp.
JW1601 is an orally available histamine H4 receptor inverse agonist with anti-pruritic and anti-inflammatory dual effect. It shows anti-chemotactic activity in eosinophil shape change and therapeutic effect in spontaneous NC/Nga AD model. JW1601 is currently conducting pre-clinical toxicity study and looking for phase 1 IND submission in 2018 in Korea. JW1601 is an investigational compound that is not approved for any use in any country.
Subscribe to releases from LEO Pharma
Subscribe to all the latest releases from LEO Pharma by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from LEO Pharma
LEO Pharma A/S acquires rights to develop and market brodalumab for moderate-to-severe psoriasis outside of Europe13.8.2019 11:30:00 CEST | Press release
New sub-licensing agreement allows LEO Pharma to help more people around the world with an additional treatment option for psoriasis. August 13th, 2019, Ballerup, Denmark: LEO Pharma A/S, a global leader in medical dermatology, today announced it has acquired the exclusive rights to develop and market brodalumab (marketed as Kyntheum® in the European Union) for the treatment of moderate-to-severe psoriasis outside of Europe through a new sub-licencing agreement with Bausch Health Ireland Limited. The new agreement includes countries with significantly high unmet need, such as Australia, Brazil, Egypt, Mexico, Russia and Saudi Arabia. This complements the ongoing licensing agreement between LEO Pharma A/S and AstraZeneca to develop and market brodalumab for the treatment of moderate-to-severe psoriasis in Europe. To date, LEO Pharma A/S has successfully launched brodalumab in 18 countries. Outside of the EU, Bausch Health Companies Inc. through a licensing agreement with AstraZeneca, ha
LEO Pharma completes the acquisition of Bayer’s pre-scription dermatology business2.7.2019 09:00:00 CEST | Press release
LEO Pharma and Bayer announced today the achievement of the relevant closing conditions to allow the transfer of Bayer’s global prescription dermatology business to LEO Pharma. The companies first announced the proposed transaction on July 31, 2018 and completed the first step of the acquisition with the closing in the United States on September 4, 2018. Today’s second and final closing covers all other countries.
LEO Pharma udnævner Catherine Mazzacco som ny CEO3.6.2019 09:00:00 CEST | Pressemeddelelse
Ballerup, den 3. juni 2019. LEO Pharma offentliggjorde i dag, at Gitte Aabo efter 27 år i virksomheden – og heraf de seneste 11 som adm. direktør – træder tilbage fra posten som øverste chef den 31. juli 2019. Bestyrelsen har udpeget Catherine Maz-zacco som ny adm. direktør med tiltrædelse 1. august.
LEO Pharma Strengthens US footprint and Global Development Team with appointment of Vice Presidents for Global Regulatory Affairs and Global Project Management10.5.2019 10:27:35 CEST | Press release
Ballerup, Denmark, May 10, 2019 – LEO Pharma A/S, a global leader in medical dermatology, today announced the appointment of Beth-Anne Lang, Vice President and Head of Global Regulatory Affairs and Christine Garrett, Vice President and Head of Global Project Manage-ment. Both will join LEO Pharma on May 13.
New General Manager appointed to lead LEO Pharma across the Nordic region1.5.2019 10:12:37 CEST | Press release
Klaus Abel arrives to take the regional helm of the global medical dermatology leader
New data show that LEO Pharma’s Kyntheum® (brodalumab) sustains PASI 100 scores longer than ustekinumab for people with moderate-to-severe plaque psoriasis25.4.2019 09:12:24 CEST | Press release
Ballerup, Denmark, April 25, 2019: LEO Pharma A/S, a global leader in medical dermatology, today announced that new data presented this week at the 6th Congress of the Skin Inflammation and Psoriasis International Network (SPIN) in Paris demonstrate that more patients with moderate-to-severe psoriasis who received treatment with brodalumab maintained a PASI (Psoriasis Area Severity Index) 100 score for longer than those who were treated with ustekinumab over 52 weeks.
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom