AMSTERDAM–(BUSINESS WIRE)–Modra Pharmaceuticals (“Modra”) today announced positive data from its Phase IIb trial evaluating its taxane-boosted oral drug, ModraDoc006/r, in patients with metastatic castration (mCRPC) versus standard of care, IV chemotherapy docetaxel. ModraDoc006/r is an oral tablet formulation of docetaxel co-administered with ritonavir, a booster agent that improves bioavailability. In a total of 101 patients included, ModraDoc006/r demonstrated similar efficacy and an improved safety profile compared to docetaxel IV, with a reduction in neutropenia, neuropathy and alopecia. Data from the trial will be presented at the 2022 American Society of Clinical Oncology Annual Symposium on Genitourinary Cancers (ASCO GU) to be held February 17-19, 2022, a year after Modra shared the data. of his initial study at the same conference.
“The completion of this study is an exciting milestone for Modra, as we continue to demonstrate the potential of ModraDoc006/r as a valuable alternative to IV chemotherapy for mCRPC.said Colin Freund, CEO of Modra Pharmaceuticals. “Our goal with ModraDoc006/r is to provide a better tolerated, effective and more convenient oral taxane for prostate cancer patients, including those who cannot tolerate or otherwise access IV therapy. Based on the compelling data currently reported, we are planning the next steps in the development of ModraDoc006/r, including a pivotal study. We would like to sincerely thank the patients and clinicians who participated in this study.”
Of the total study population, 49 patients received docetaxel IV and 52 ModraDoc006/r (21 on 30-20/200-100 mg (“30-20”) and 31 on 20-20/200-100 mg (“20-20”) Twice Daily Weekly Dosing (BIDW) doses). ModraDoc006/r vs docetaxel IV demonstrated an overall response rate (ORR) of 44% versus 39%, respectively. Prostate specific antigen (PSA) responses were comparable at 50% versus 57%, respectively. Neutropenia (low level of neutrophils, a type of white blood cells) was eliminated with ModraDoc006/r at the 20-20 mg dose, reduced to 14% at the 30-20 mg dose versus 25% with docetaxel IV. Neuropathy (nerve damage or dysfunction) and alopecia were also reduced with ModraDoc006/r 20-20 mg compared to 30-20 mg and docetaxel IV. Gastrointestinal toxicities were slightly more frequent, but still predominantly mild, in the ModraDoc006/r arm at both dose levels.
“ModraDoc006/r showed a favorable toxicity profile and efficacy comparable to IV docetaxel in metastatic CRPC. Patients with advanced prostate cancer often do not experience the benefits of IV docetaxel chemotherapy due to advanced age, comorbidities and, during the pandemic, fear of being exposed to Covid-19 in infusion centers. More tolerable oral chemo – with less risk of cytopenias, hair loss and neuropathy – would make the benefits of chemo accessible to the majority of patients with metastatic prostate cancer. Thus, there is compelling justification to further evaluate ModraDoc006/rsaid Ulka Vaishampayan, MD, the study’s principal investigator and professor of internal medicine, division of hematology/oncology at the University of Michigan.
The randomized 1:1 open-label study evaluated a ModraDoc006/r BIDW regimen versus docetaxel IV 75 mg/m2 in cycles of 21 days. Initially, a dose of 30-20/200-100 mg of BIDW (representing 30 mg of ModraDoc006 and 200 mg of ritonavir in the morning, 20 mg of ModraDoc006 and 100 mg of ritonavir in the evening) was administered on days 1, 8 and 15 of a 21 day program. cycle. After 21 patients, the morning dose of ModraDoc006 was reduced to 20 mg to improve tolerance. All patients received prednisone 5 mg orally twice daily. The primary endpoint of the study was radiographic progression-free survival (rPFS) according to PCWG-3 criteria. Secondary objectives were ORR, PSA-PFS, time to skeletal events, rate of disease control, duration of response, and safety ratings. Patient-reported outcomes and health-related quality of life (QoL) were assessed with treatment satisfaction and Functional Assessment of Prostate Cancer Treatment (FACT-P) questionnaires at baseline and after treatment. cycle 3, 6 and 10.
About metastatic castration-resistant prostate cancer (mCRPC)
mCRPC is an advanced form of prostate cancer and the fourth leading cause of cancer death overall. mCRPC is not amenable to surgical treatment and is resistant to androgen deprivation therapy, a hormonal therapy used as an initial treatment for the disease to reduce the growth of prostate cancer cells.
ModraDoc006/r is a patented docetaxel-based boosted taxane therapy, an intravenously administered therapy, which is very widely 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 convenience of taking chemotherapy treatment at home with the potential for an improved safety profile, compared to standard IV docetaxel.
About Modra Pharmaceuticals
Modra Pharmaceuticals aims to transform taxane therapy by developing therapies that are less toxic, more effective, and can be taken at home in tablet form. The company’s goal is to significantly improve the treatment outcomes and daily lives of the hundreds of thousands of cancer patients undergoing taxane therapy worldwide. Modra’s lead program has completed a Phase 2b clinical study in prostate cancer, resulting in a positive date further supporting the administration, bioavailability and tolerability of its novel approach.