UPPSALA, SWEDEN – LIDDS AB (publ) announced today an update on the clinical program for the prostate cancer drug candidate Liproca® Depot. Based on the interactions that LIDDS’ licensee for China, Jiangxi Puheng Pharma, has had with the Chinese National Medical Products Administration (NMPA) it is recommended that clinics in China participate in an international multicenter study. LIDDS is continuing its work to select licensees in other markets that will support and share the cost in such a Phase III multicenter study.
As a consequence of the request from NMPA and the overall Liproca® Depot strategy, Jiangxi Puheng Pharma will not apply for the novel expeditated regulatory path, Conditional Market Approval. Further on, LIDDS and Jiangxi Puheng Pharma has decided to plan a multicenter Phase III study.
“As an international multicenter Phase III trial is requested there is no reason to submit the CMA application to NMPA. Instead, we save time by already now planning a Phase III study which lead to the benefit of cost sharing between the Liproca® Depot licensees. We also believe that we can stick to the initial timeline as we together with Puheng Pharma already have made intensive joint preparations including compilation of a registration dossier and developing a Phase III study protocol,” said Monica Wallter, CEO of LIDDS. “We believe that the Liproca® Depot license has become even more attractive for our license partners as it will be possible to share costs for the upcoming Phase III study with Puheng Pharma.”
LIDDS will provide further details on the Phase III study design and time plans after further regulatory interactions and finalization of new license agreements for other markets. The aim is to launch the Phase III study in 2022.
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 treatment for these cancer patients and many treating physicians 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®- technology 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. The final data from the LPC-004 study confirms Liproca® Depot’s potential as an anti-androgen treatment for prostate cancer patients that are currently under ‘Active Surveillance’. The study met both primary and secondary endpoints. PSA was decreased in 95 percent of the patients with maximum PSA response of 67 percent. MRI data showed no progression of prostate cancer in any patients and regression was even observed in some patients.
For more information, please contact:
Monica Wallter, CEO, +46 (0)737 07 09 22, e-mail: 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 March 30, 2021 at 08:30 CET.
LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology: NanoZolid®. NanoZolid is superior to any drug delivery technology 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 for cytostatics and immunoactive agents. LIDDS shares are listed on Nasdaq First North (LIDDS). Redeye AB is the Certified Adviser to LIDDS (+46 (0) 8 121 576 90, email: certifiedadviser@redeye.se) For more information, please visit liddspharma.com.