fbpx

LIDDS announces positive meeting with the Swedish Medical Products Agency, confirming the Liproca® Depot Phase III study design

LIDDS announces positive meeting with the Swedish Medical Products Agency, confirming the Liproca® Depot Phase III study design
18 May, 2020

UPPSALA, SWEDEN – LIDDS AB (publ) announces that the company has received positive responses from the Swedish Medical Products Agency (MPA) regarding the proposed design of the Phase III study of Liproca® Depot for patients with localized prostate cancer, within the intermediate risk group. The Swedish MPA decision is an important validation of LIDDS study results and Liproca® Depot’s potential and is a central part of the Company’s Phase III preparations.

The proposed study design, discussed with the MPA, involves patients with localized prostate cancer, having an intermediate risk profile. The phase III primary endpoint is time to disease progression, prompting a radical treatment (i.e. surgery or radiation), over 24 months for Liproca® Depot compared to an active surveillance schedule.

The Swedish MPA also confirmed that a single pivotal Phase III study can be sufficient for a future registration of Liproca® Depot, provided positive results. The MPA proposed no changes to LIDDS’ suggested study design.

-The meeting with the MPA is an important milestone in the planning of the Phase III study and it confirms LIDDS’ strategy to offer local cancer control treatment for this patient category. Liproca® Depot will benefit prostate cancer patients both in terms of efficacy and maintained quality of life. Prostate cancer is a fast-growing cancer disease and the incidence level is expected to increase with 80 percent globally until 2040.  Therefore, research and development in this field is of great importance, said Monica Wallter, CEO of LIDDS.

About prostate cancer and the market
Of the 1.3 million men diagnosed with prostate cancer globally each year, about 420,000 are assessed as intermediate risk and placed on ‘Active Surveillance’ where they are monitored regularly. There is no standard drug treatment for these cancer patients and many treating doctors see an unmet need.
According to the market research firm GlobalData, the global market for prostate cancer drugs is expected to grow to USD 8.3 billion annually by 2023. Liproca® Depot’s target group is an untapped market potentially USD 3 billion per year.

About Liproca® Depot and NanoZolid®
NanoZolid® is a safe, flexible and functional method of delivering drugs. When injected, NanoZolid® forms a solid depot releasing the active drug over periods of up to six months or more. As it releases its drug load, the NanoZolid® depot dissolves and is absorbed harmlessly into the body.

Liproca® Depot combines NanoZolid® and 2-HOF (2-hydroxyflutamide), a well-established prostate cancer drug. Liproca® Depot’s target group is patients under Active Surveillance (AS) with intermediate risk of cancer progression.

For additional information, please contact: 
Monica Wallter, CEO LIDDS, +46 (0)737 07 09 22, monica.wallter@liddspharma.com

This information is such that LIDDS AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above on May 18, 2020 at 15:40 CET.

LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology NanoZolid®. NanoZolid® is a clinically validated drug development technology and superior in its ability to provide a controlled and sustained release of active drug substances for up to six months. LIDDS has licensing agreements where NanoZolid is combined with antiandrogens and in-house development projects in clinical and preclinical phase for cytostatics and immunoactive agents. LIDDS (LIDDS) shares are listed on Nasdaq First North Growth Market. Redeye AB, certifiedadviser@redeye.se, +46 (0)8 121 576 90, is a certified adviser to LIDDS. For more information, please visit www.liddspharma.com.

Attachment