calcipotriol (AKP01) / Lipidor - LARVOL DELTA

AKVANO-AKP01: Efficacy and Safety of Novel Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Lipidor AB

New P1/2 trial • Dermatology • Immunology • Psoriasis

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

Preclinical Development of Sodium Fusidate Antibiotic Cutaneous Spray Based on Water-free Lipid Formulation System. (PubMed, Eur J Pharm Sci) - "A spray product based on the described formulation technology would therefore require a shorter treatment time and thereby lower the risk for the development of bacterial resistance. Spray administration of these formulations provides an even layer on the skin surface from which the solvent quickly evaporates and thereby facilitates a non-touch application where no rubbing is required."

Journal • Preclinical • Dermatology • Infectious Disease

AKVANO: A Novel Lipid Formulation System for Topical Drug Delivery-In Vitro Studies. (PubMed, Pharmaceutics) - "The ethanol content in AKVANO facilitates incorporation of many active pharmaceutical ingredients (>80 successfully tested) and the phospholipids seem to act as a solubilizer in the formulation. In vitro skin permeation experiments using Strat-M membranes have shown that AKVANO formulations can be designed to alter the penetration of active ingredients by changing the lipid composition."

Journal • Preclinical

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

AKP01: A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis (clinicaltrials.gov) - P3; N=278; Completed; Sponsor: Cadila Pharnmaceuticals

Clinical • New P3 trial • Dermatology • 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 and Cannassure enter exclusive licensing agreement regarding topical medical cannabis products based on Lipidor's AKVANO technology (PRNewswire) - "Lipidor AB...announced that the Company has signed an exclusive licensing agreement with Cannassure Therapeutics Ltd...Under the agreement, Cannassure has the exclusive right to use Lipidor's proprietary drug delivery technology AKVANO® in medicinal cannabis products for the treatment of selected indications such as psoriasis...Lipidor receives a royalty of 15-17.5% on future product sales."

Licensing / partnership • 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

Lipidor reports positive clinical Phase I/II data in psoriasis (Karolinska) - P1/2, N=24; "Today Lipidor announced positive results from a Phase I/IIa study investigating the efficacy and tolerability of its AKVANO®/calcipotriol spray formulation for the treatment of psoriasis vulgaris, the most common form of psoriasis. Karolinska Development owns 50% of Lipidor."

New molecule • P1/2 data • Psoriasis