12 February 2021
— Data Include Positive Safety and Tolerability Profile, and Preliminary Efficacy Results for Boosted Oral Formulation of Docetaxel —
— Company Announces Completion of Enrollment in the Trial —
Amsterdam, February 12, 2021 – Modra Pharmaceuticals (“Modra”) today announced preliminary data from its ongoing Phase IIb trial for lead candidate, ModraDoc006/r, a proprietary oral therapeutic based on the widely-used intravenous (IV) taxane chemotherapy, docetaxel, in metastatic Castration-Resistant Prostate Cancer (mCRPC) patients. The randomized study is evaluating the tolerability and efficacy of ModraDoc006/r versus IV docetaxel in 100 mCRPC patients eligible for first line systemic chemotherapy. Initial encouraging safety, tolerability and efficacy data were presented on February 11 during a poster highlights session at the 2021 Annual American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), held virtually from February 11 – February 13, 2021.
Separately, Modra announced that patient recruitment for the trial is now complete.
The study is an open label, randomized 1:1 trial of ModraDoc006/r administered twice daily, once per week, versus the standard of care IV docetaxel administered on a 21-day cycle. At the data cut-off of November 30, 2020, 98 patients were enrolled worldwide; 49 patients each have been randomized to IV docetaxel and to ModraDoc006/r, with 58 patients currently on treatment. Initial observations suggest a favorable safety and tolerability profile for ModraDoc006/r compared to IV docetaxel at its standard dose of 75mg/m2. ModraDoc006/r at a 20-20mg dose1 exhibited mild gastro-intestinal toxicities, with no signs of hematological toxicity or neuropathy, which represent the typically expected dose-limiting toxicities for IV docetaxel. Based on oral administration, ModraDoc006/r also eliminated traditional taxane induced infusion-related reactions and was administered without corticosteroid premedication. Over 50% of patients are still receiving treatment, but preliminary efficacy data of ModraDoc006/r are encouraging, including decreases in Prostate-Specific Antigen (PSA) levels; these data continue to evolve as follow-up continues. Now fully enrolled, the trial will proceed with investigating its primary endpoint, radiographic progression free survival (rPFS), as well as secondary endpoints including efficacy, safety and health-related quality of life assessments.
“The initial data suggest a remarkably favorable toxicity profile, without signs of cytopenia or neuropathy, in patients treated with ModraDoc006/r at the weekly dose of 20 mg twice in a day. The risk of infection and anemia are critical hurdles in the use of IV docetaxel in mCRPC and limit its usage despite its established position as standard of care in this patient population. This speaks to the importance of providing an alternative therapeutic such as ModraDoc006/r to address the unmet need still present in standard treatment of this disease and to improve outcomes in mCRPC,” said Ulka Vaishampayan, MD, Principal Investigator of the study and Professor of Internal Medicine, Division of Hematology/ Oncology at the University of Michigan.
“Our trial continues to demonstrate the potential of ModraDoc006/r as a better tolerated, convenient oral therapeutic option for patients with metastatic CRPC. The tablet formulation has the potential to extend this treatment option to an increasing number of mCRPC patients, including otherwise underserved patient populations such as the elderly, those with significant comorbidities and those who cannot tolerate IV docetaxel. The critical need for an easily administered oral treatment that eliminates the need to go to a hospital or clinic for an infusion, thereby also reducing exposure time, has been made more apparent by the COVID-19 pandemic. We look forward to further investigating ModraDoc006/r and supporting its development for the benefit of mCRPC patients,” commented Colin Freund, CEO of Modra.
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 not amenable to surgical treatment and resistant to androgen deprivation therapy, a hormone therapy used as initial disease management to reduce 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, 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.
1. 20mg ModraDoc006 (morning and evening), 200mg ritonavir (morning) & 100mg ritonavir (evening).
CEO, Modra Pharmaceuticals
Tel: +1 609 933 8008
Gretchen Schweitzer or Valeria Fisher
Tel: +49 (0) 89 2388 7735 or
+49 (0) 175 804 1816