Le Lézard
Classified in: Health, Science and technology, Business
Subject: CON

Lipidor Signs Agreement With CRO for Implementation of Phase III Clinical Study of Drug Candidate AKP-02 Against Psoriasis

STOCKHOLM, July 8, 2020 /PRNewswire/ --  Lipidor AB (Nasdaq First North: LIPI) today announced an agreement with Cadila Pharmaceuticals, a leading Indian pharmaceutical company with extensive CRO capacity, to conduct a Phase III study for Lipidor's drug candidate AKP-02. The study is expected to commence in Q1 2021 with final reporting in Q1 2022.

AKP-02 is an antipsoriasis medicine that combines the active substances calcipotriol and betamethasone with Lipidor's spray-based AKVANO technology. The market for "combo products" reached USD $580 million per year in 2017*, and Lipidor expects to be able to claim a significant market share when the drug reaches the market. Lipidor has previously announced the intention to conduct a fully self-funded Phase III study with the drug candidate AKP-02 in 2020 (see previous press release of 7 May 2020). An agreement has now been concluded with Cadila Pharmaceuticals for the implementation of the study.

* Data from Datamonitor

"We're very pleased to announce that we have entered into an agreement to carry out a registration-based Phase III study for AKP-02, Lipidor's combination drug candidate against psoriasis. Through the successful Phase III study for AKP-01, Cadila has shown that they can effectively recruit patients, administer dosing and report clinical study results. The experience of AKP-01 means that we have high hopes for effective cooperation and a successful study," says Ola Holmlund, Lipidor CEO.

The Phase III study is expected to involve 270 patients and will be conducted in India on patients with various skin types. The intention is to demonstrate equivalent therapeutic efficacy with existing medicines for mild to moderate psoriasis. The observer-blind and placebo-controlled trial is expected to be completed in Q4 2021 with reporting in Q1 2022.  Lipidor has already collaborated with Cadila regarding the drug candidate AKP-01 and this new agreement now strengthens that cooperation.

"The market has shown great interest in AKP-02 and by self-funding the implementation of the Phase III study, we will maximize the benefits of later out-licensing. We continue to see great potential in our first drug candidate AKP-01, and the opportunity to now discuss AKP-01 and AKP-02 in a package makes us an even more attractive partner for pharmaceutical companies that can take our products through registration for sale," concludes Ola Holmlund.

The cost of the Phase III study is covered by Lipidor's existing funds. Discussions with clinical trial material manufacturers are ongoing and an agreement is expected to be in place in Q3 2020.


This information above was provided by Lipidor according to EU Market Abuse Regulations. The information was provided, through the below contact person, for publication on 7 July 2020 at 11.10 am (CET).


For more information, please contact

Ola Holmlund, CEO
Phone: +46 72 50 70 369
E-mail: ola.holmlund@lipidor.se

Certified Adviser

Corpura Fondkommission AB
Telephone: +46 76 85 32 822
E-mail: ca@corpura.se

This information was brought to you by Cision http://news.cision.com


The following files are available for download:


200707 Lipidor PR Study agreement AKP02 EN.pdf

SOURCE Lipidor

These press releases may also interest you

at 22:24
ZKSwap, a decentralized exchange based on the ZK-rollups layer-two scaling solution, is unveiling the 2.0 version testnet at 3:00 UTC on June 23rd, 2021, which highlights the Unlimited Token Listing feature. ZKSwap charges no fees for token listing....

at 22:00
Today, Chinafy, a product of Notey Limited and current AWS Technology Partner, announced that they are expanding their collaboration with AWS to provide their solution through AWS Marketplace. AWS customers can now use Chinafy's enhanced cross-border...

at 21:00
Zum achten Mal in Folge ist Sevan Multi-Site Solutions, Inc. (Sevan), ein führender Anbieter in den Bereichen innovatives Design, Programmmanagement, Baudienstleistungen und Datenanalyse für Organisationen mit mehreren Standorten, als hervorragender...

at 20:25
Wiland, Inc., a leading provider of data-driven predictive marketing solutions, today announced that Drew May has been named as the Company's Chief Revenue Officer. He most recently served as Wiland's Executive Vice President, New Business...

at 20:23
The computational fluid dynamics (CFD) market in APAC is expected to grow by USD 173.68 million during 2021-2025, according to Technavio. The report offers a detailed analysis of the computational fluid dynamics (CFD) market in APAC in optimistic,...

at 20:23
Viatris today announced that the U.S. District Court for the District of Kansas ruled, in substantial part, in Mylan's favor on the company's summary judgment motion in the class action related to EpiPen® Auto-Injector. The company is pleased with...

News published on 8 july 2020 at 02:47 and distributed by: