betamethasone/calcipotriol (AKP02) / Lipidor, Menarini - LARVOL DELTA

AKVANO-AKP02: A Phase III Study in Subjects With Mild to Moderate Psoriasis. (clinicaltrials.gov) - P3 | N=294 | Recruiting | Sponsor: Lipidor AB | Completed ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Phase III Study in Subjects With Mild to Moderate Psoriasis. (clinicaltrials.gov) - P3 | N=294 | Completed | Sponsor: Lipidor AB | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jul 2022 | Trial primary completion date: Dec 2022 ➔ Jul 2022

Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

A Phase III Study in Subjects With Mild to Moderate Psoriasis. (clinicaltrials.gov) - P3 | N=294 | Recruiting | Sponsor: Lipidor AB

New P3 trial • Dermatology • Immunology • Psoriasis

Lipidor announces approval to start Phase III clinical study of drug candidate AKP02 for treatment of psoriasis (PRNewswire) - "Lipidor AB...announced today that the company's Phase III clinical study of its drug candidate AKP02 for the treatment of psoriasis has been approved by the Indian Medical Products Agency and is ready to start. The main purpose of the study is to compare the therapeutic efficacy of AKP02 with Enstilar, the current market leader, for mild to moderate psoriasis. As Lipidor previously announced, results from the study are expected in the first half of 2022...The observer-blind and placebo-controlled Phase III study is expected to have the first patient in-treatment during this fall with reporting in the first half of 2022."

New P3 trial • P3 data • Immunology • Psoriasis

Lipidor AB licence agreement grants Menarini Group company, RELIFE Srl, exclusive rights to register, promote, distribute and market two new psoriasis drug candidates for potential value of MEUR 70 (PRNewswire) - "Lipidor AB...announced today that it has signed a licence agreement under which Lipidor grants RELIFE S.r.l., part of leading international pharmaceutical company, Menarini Group, exclusive rights to register, promote, distribute, and market drug candidates for the treatment of psoriasis in EU, Turkey, UK, Switzerland, CIS, and Balkan countries. The total potential value of this agreement is up to MEUR 70...Results from the Phase III study of this second candidate, currently in its initial stages, are expected for the first half of 2022."

Licensing / partnership • P3 data • Immunology • Psoriasis

Lipidor signs cooperation agreement with contract manufacturer to offer licensees the opportunity for GMP production (PRNewswire) - "Lipidor...announced today that the Company has signed a new cooperation agreement with Aurena Laboratories AB. Over a five-year period, Lipidor will invest up to SEK 15 million in the new collaboration. Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor's pharmaceutical products...This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis...According to the first target milestone, the production unit shall be ready to manufacture so-called stability batches for registration documentation during the first half of 2021."

Licensing / partnership • Psoriasis