First Patient enrolled in Phase III trial of AKVANO® Calcipotriol Spray, a new high- comfort, high-control anti-psoriasis spray
Psoriasis is a chronic disease affecting 2-4% of the world’s population. A new anti-psoriasis spray now in phase III trial offers more comfort to patients, and improves dose control. The first patient has now entered the trial.
Lipidor’s Calcipotriol Spray is being evaluated over 8 weeks of treatment in a randomized multicentre placebo-controlled phase III trial. The primary endpoint is to assess the therapeutic equivalence of the Calcipotriol Spray with comparator product. In total 266 patients with mild to moderate psoriasis will be enrolled in the trial.
“We are pleased to have enrolled the first patient in this phase III trial, which has been designed to support registration in Europe, North America and other major markets.”, says Lipidor CEO Ola Holmlund. “We believe that Calcipotriol Spray formulated using our patented AKVANO® technology will offer a great advantage compared to standard treatments regarding patient comfort and dose control”.
The lipid-based AKVANO® formulation has unique properties and in a previous study carried out at a Swedish Psoriasis Society Clinic, 74% of psoriasis patients preferred AKVANO® spray over conventional cream treatment.
The world market for psoriasis products is estimated to reach 21 bio USD by 2022. Patient comfort and dose control is a challenge for creams and ointments, the most common dosage forms used today. There is a tremendous opportunity for a new psoriasis product based on an improved delivery technology to play a key role on the market.
Cerbios-Pharma SA is the cGMP API manufacturer of Calcipotriol and supplier of clinical trial material for the phase III trial, while Cadila Pharmaceuticals is responsible for the clinical phase III trial, carried out at 10 centers in India.
“We are driven by research-based innovations that provide care and affordable solutions to our patients”, confirms Dr. Rajiv Modi, Chairman of the Board and Managing Director of Cadila Pharmaceuticals Ltd. “Our partnership with Lipidor will help to bring forward a superior solution for psoriasis which will ensure greater compliance and efficacy.”
Lipidor is looking for licensing partners for registration and market introduction of its Calcipotriol Spray, which is protected by granted patents and patent applications.
About Lipidor AB
Lipidor is a Swedish biotech company developing treatments for severe skin conditions based on its proprietary lipid based spray formulation technology, AKVANO. With AKVANO, improved versions of already marketed products can be developed to cover either unmet medical needs or improve quality-of-life of the patient. The company was established in 2009. Research and development is conducted at Stockholm University and Karolinska Institutet Science Park in Stockholm
About Cadila Pharmaceuticals Ltd
Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India. Over the last six decades, the company has been developing and manufacturing pharmaceutical products in India and selling and distributing these in over hundred countries around the world. The company is present in more than forty-five therapeutic areas spread across twelve specialties. A pioneer in providing affordable care, this company has developed many first-in-the-world innovations for the treatment of cardiovascular diseases, tuberculosis, lung cancer and seasonal influenza.
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Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacture of both chemical and biological APIs for its partners world-wide.
Exclusive, third-party manufacturing services are offered by the Chemical Division for HPAIs and by the Biological Division for monoclonal antibodies, recombinant proteins and pharma probiotics.
Cerbios provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India.