Preliminary results from Phase IIb Liproca® Depot dose-finding study show a strong maximum PSA decrease and sustained PSA reduction effect

Study confirms Liproca® Depot’s potential as drug treatment for men with prostate cancer who currently are under ‘Active Surveillance’ and receiving no treatment

UPPSALA, SWEDEN. Lidds AB (publ) – LIDDS has today announced preliminary data from the LPC-004 study that aimed to determine the tolerability of Liproca® Depot and the Prostate-Specific Antigen (PSA) effect at month 5 on patients in part II of the study.

The PSA reduction for part II patients was in line with the expected pattern for Liproca® Depot’s sustained release and maximum PSA reduction (PSA nadir) occurred during months 2-4. The patients in part II showed a strong PSA decrease and a continued PSA reduction at month 5 as well as over the full study period of six months, confirming the NanoZolid® technology’s sustained release profile.

67 % of patients receiving 16 ml dose were determined as responders. A responder is defined as a patient experiencing a PSA decrease of 15% or more. 90% of patients who received a 16 ml injection experienced a PSA decrease during their Liproca® Depot treatment.

The positive preliminary results show Liproca® Depot’s ability to reduce PSA levels over a period of six months, proving the NanoZolid® technology´s suitability for local cancer treatment. The study also confirms the technology’s favorable toxicity and tolerability profile.

All patients in the study were under Active Surveillance with low or intermediate risk of cancer progression and these patients currently receive no treatment.

- Patients under Active Surveillance have a risk of cancer progression which places additional stress on them. Liproca® Depot could provide an option for physicians to address an unmet medical need, says Anders Bjartell, Professor and Senior Consultant at the Department of Urology, Skåne University Hospital, and LIDDS Board Member.

- Liproca® Depot was well tolerated without the hormonal side effects associated with anti-androgen therapies and a majority of patients in the study were positive to receiving a second injection. Administering Liproca® Depot is similar to performing a prostate biopsy, says Professor Laurence Klotz, a world leading expert and one of the study investigators and Professor at the University of Toronto Division of Urology.

- These results validate the continued clinical development of Liproca® Depot. LIDDS has already signed a license agreement for China with the pharmaceutical company Jiangxi Puheng which plans to conduct and finance a Phase III study. LIDDS will now continue the commercial activities in order to sign further licensing agreements in other major markets, says Monica Wallter, CEO, LIDDS.

Professor Klotz will present the Phase IIb study results in detail at the 11th European Multidisciplinary Congress on Urological Cancers (EMUC19) in Vienna, Austria, on November 16, 2019. A paper reporting the results of the Phase IIb study will be submitted to leading scientific journals for publication.

For more background information about the Phase IIb Liproca® Depot clinical trial, please see enclosed file.

About prostate cancer and the market:
Of the 1.2 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 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 exceeding USD 3 billion per year.

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

LIDDS is required to disclose the information in this press release under the European Union’s Market Abuse Regulation. The information was submitted through the agency of the aforementioned contact person for publication on September 24, 2019 at 08:30 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.

Attachments

• LIDDS PR 190824 LPC-004 preliminary results
• LIDDS Backgrounder Liproca Depot Phase IIb preliminary results