Brazil grants patent for VAL001

 The Brazilian National Institute of Industrial Property (INPI) has announced the intent to grant Respiratorius patent for VAL001. 

After the formal fees have been paid, the patent will be granted, which will give Respiratorius market exclusivity in Brazil until 2031. Previously, the patent has been granted in Europe, US, Japan, Canada, and Korea under equivalent conditions.

The patent covers a combination of an HDAC inhibitor and a steroid for pre-treatment with standard chemotherapy (R-CHOP) in the treatment of diffuse large B-cell lymphoma (DLBCL), a lymphoma which annually affects about 60,000 people in the United States and Europe. DLBCL is the most common type of Non-Hodgkin's lymphoma, and comprises 30% of diagnosed lymphoma patients in the EU.

In Q2 2018, a phase I/IIa study of valproate, in combination with R-CHOP, was completed with the following results:

• Potential synergistic effect with rituximab as valproate increases the levels of the surface protein CD20.
• Overall Survival Analysis for 32 patients treated with valproate and R-CHOP showed that 1-year survival was 100% and 2-year survival was 96.8%. Comparative data from a matched reference population of 330 patients in the Swedish lymphoma registry treated with R-CHOP alone provided a 1-year survival of 89.6% and a 2-year survival of 81.7%. This shows a statistically assured survival benefit (p = 0.034) for patients treated with valproate and R-CHOP compared to those treated between 2000-2015 with R-CHOP alone.

The combination is thus superior to other treatments according to the results from the phase I/IIa study, in which valproate + R-CHOP displayed a very large reduction in risk of mortality,> 50%, compared to the 20-30 percent reduction in mortality considered to be clinically relevant for oncology drugs in general.As previously communicated, Orphan Drug Designation in Europe and the United States has been granted, giving market exclusivity for 10 and 7 years, respectively, from market approval.

"Further patent approvals strengthen the patent portfolio for VAL001." says CEO Johan Drott in a comment.

This disclosure contains information that Respiratorius is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 29-09-2021 08:32 CET.

Johan Drott

President Respiratorius AB

+46 709-22 41 40

johan.drott@respiratorius.com

Respiratorius AB (publ) is developing drug candidates with the goal to launch drugs for common diseases cancer, chronic obstructive pulmonary disease (COPD) and severe asthma. In addition, the project portfolio is a project for improved diagnosis of certain cardiovascular diseases.