AMSTERDAM--(BUSINESS WIRE)--Modra Pharmaceuticals B.V. (“Modra”) today announced the start of patient treatment in its Phase IIb clinical study evaluating the efficacy and tolerability of its lead candidate, ModraDoc006/r, in metastatic Castration-Resistant Prostate Cancer (mCRPC). ModraDoc006/r is a proprietary oral therapeutic based on the standard intravenous taxane chemotherapy, docetaxel. In evaluation to-date, ModraDoc006/r has shown potential to reduce important toxicities, such as neutropenia and neuropathy, with the possibility of enhancing the efficacy of treatment, in addition to providing the benefits of oral ‘at-home’ administration. The trial will be conducted at approximately 40 clinical centers in the United States and Europe, with initial data readout expected during the first half of 2021. The compound is also being tested in a Phase II clinical study in breast cancer, which began earlier this year.
“Prostate cancer is one of the most commonly diagnosed malignancies in men in the Western world, with docetaxel typically administered as the first line of chemotherapy treatment in the metastatic setting. Improving outcomes for these patients by reducing key toxicities and enhancing efficacy associated with the use of chemotherapy would meet a significant need. Our objective is therefore to demonstrate clinical benefit over current standard of care while also making a positive impact on patients’ lives,” commented Colin Freund, CEO of Modra.
“Based on our existing pre-clinical and clinical data, we believe ModraDoc006/r has the potential to favorably impact treatment outcomes and raise the quality of life for prostate cancer patients,” explained Dr. Edwin de Wit, Chief Development Officer of Modra. “This comparative Phase IIb trial will enable us to evaluate the benefits of oral ModraDoc006/r versus standard of care intravenous docetaxel.”
The Phase IIb study, randomized 1:1 Modra006/r versus intravenous docetaxel, will evaluate 100 mCRPC patients eligible for first line systemic chemotherapy. The primary endpoint is objective response rate as assessed by response evaluation criteria in solid tumors (RECIST 1.1). The secondary endpoints include efficacy, safety and health-related quality of life assessments.
“Intravenously administered chemotherapy is widely used, but nevertheless always involves a significant time investment for patients in regard to travel to and from the clinic and receiving the treatment itself, as well as the considerable burden of dealing with its side effects. To that end, ModraDoc006/r has the potential to become an exciting new oral option for prostate cancer which retains or improves on the therapeutic characteristics of docetaxel and easily incorporates chemotherapy within the lives of cancer patients,” added Ulka Vaishampayan, MD, Principal Investigator of the study and Professor of Oncology at Karmanos Cancer Institute, Detroit.
About metastatic Castration-Resistant Prostate Cancer (mCRPC)
mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is resistant to surgical treatment or androgen deprivation therapy, an antihormone therapy used to prevent the growth of prostate cancer cells.
ModraDoc006/r is a proprietary boosted taxane chemotherapy based on docetaxel, an intravenously administered therapy that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet - is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile and enhanced efficacy, as compared to standard IV docetaxel.
About Modra Pharmaceuticals
Modra Pharmaceuticals aims to re-define taxane chemotherapy by developing therapies that are less toxic, more effective and can be taken at home in tablet form. The Company’s goal is to radically improve the therapeutic outcomes and everyday lives of the hundreds of thousands of cancer patients undergoing taxane chemotherapy worldwide. Modra’s lead program is advancing into Phase 2 clinical studies in prostate and breast cancer to further demonstrate the value of the approach.