LEO PharmaLEO Pharma

LEO Pharma files IND application to FDA for a clinical study of JW1601/LP0190 in the US

Share

- 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.

Contacts

Contact:
LEO Pharma
Henrik Kyndlev
+45 3140 6180
hdtdk@leo-pharma.com

US inquiries
LEO Pharma US
Rhonda Sciarra
+1 973 637 8019
+1 862 337 0675
rasus@leo-pharma.com

About LEO Pharma

LEO Pharma
LEO Pharma
Industriparken 55
2750 Ballerup

4494 5888http://www.leo-pharma.com/

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.

For more information, visit www.leo-pharma.com or follow us on LinkedIn: www.linkedin.com/company/leo-pharma

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.

ABOUT JW1601
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 presents results from study of twice-weekly Enstilar® (calcipotriene and betamethasone dipropionate) Foam for topical use in long-term maintenance treatment of plaque psoriasis12.6.2020 21:20:42 CESTPress release

New results from the PSO-LONG clinical trial are the first to provide long-term maintenance data for plaque psoriasis with a twice-weekly topical treatment with Enstilar®(calcipotriene and betamethasone dipropionate) Foam Plaque psoriasis is a chronic, multifactorial disease affecting nearly 80% of the 125 million people living with psoriasis worldwide(1,2) LEO Pharma is committed to building on its more than 30-year heritage of pursuing innovative products for patients affected by psoriasis and other chronic skin conditions BALLERUP, Denmark, JUNE 12, 2020 – LEO Pharma A/S, a global leader in medical dermatology, today presented results from the Phase 3 PSO-LONG clinical trial. PSO-LONG compared the efficacy and safety of twice-weekly Enstilar® (calcipotriene and betamethasone dipropionate)Foam, versus foam vehicle for long-term (52-week) maintenance treatment for adult patients with plaque psoriasis.(3,4) Results were presented as ePosters online at the American Academy of Dermatolog

Tralokinumab achieves primary and secondary endpoints in three pivotal Phase 3 trials in adult patients with moderate-to-severe atopic dermatitis12.6.2020 21:06:15 CESTPress release

Presented at the AAD VMX 2020, results from ECZTRA 1, 2 and 3 trials confirm tralokinumab met its primary and secondary endpoints and are the first Phase 3 results in atopic dermatitis for an investigational therapy that specifically targets IL-13 Tralokinumab demonstrated statistically significant improvements in outcomes including pruritus (itch) and health-related quality of life measures that are important to patients In ECZTRA 1 and 2, the majority of patients treated with tralokinumab 300 mg every two weeks who achieved a clinical response at week 16, maintained response at week 52 without any use of topical corticosteroids In ECZTRA 3, nine out of 10 patients who achieved clear or almost clear skin with tralokinumab 300 mg in combination with topical corticosteroids at week 16 maintained this response at week 32 when randomized to dosing every two weeks. Similarly, eight out of 10 patients randomized to dosing every four weeks at week 16 maintained clear or almost clear skin at

LEO Pharma announces European Medicines Agency acceptance of marketing authorization application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis11.6.2020 14:00:00 CESTPress release

BALLERUP, Denmark, JUNE 11, 2020 – LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for tralokinumab, an investigational product for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD). The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

LEO Pharma Enters License Agreement with Oneness Biotech and Microbio Shanghai for FB825 a Novel Atopic Dermatitis and Asthma Drug Candidate15.4.2020 07:45:16 CESTPress release

BALLERUP, Denmark, April 15, 2020 – LEO Pharma A/S, a global leader in medical dermatology, today announced that is has signed a worldwide exclusive licensing agreement with Oneness Biotech (Taiwan, TPEx: 4743) and Microbio Shanghai (China) covering the development and commercialization of the novel Atopic Dermatitis (AD) and Allergic Asthma drug candidate, FB825.

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