Modra Pharmaceuticals ("Modra") today announced the final results of the lower dose cohort in the Company's Phase 2b trial evaluating its oral taxane therapeutic, ModraDoc006/r, in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) compared to standard-of-care IV chemotherapy docetaxel at 75 mg/m2 Q3W. ModraDoc006/r is an oral tablet formulation of docetaxel co-administered with ritonavir, a boosting agent which enhances bioavailability. The lower 20-20/200-100mg dose demonstrated a significantly improved safety profile compared to IV docetaxel while maintaining efficacy levels. Based on these encouraging results, this optimal dose has been selected for Modra's planned Phase 3 pivotal trial in mCRPC patients. The Phase 2b data will be presented in a "poster discussion" presentation at the ASCO Annual Meeting 2022, held from June 3 ? 7.
"The detailed analysis of the lower dose cohort has demonstrated that we can further improve the safety profile for ModraDoc006/r without compromising activity, making it a very attractive option to deliver chemotherapy. Now, with the optimal dosage of ModraDoc006/r selected, we are well-positioned to enter Phase 3 clinical testing and get one step closer to bringing a safer, effective and more convenient alternative to IV chemotherapy to patients living with mCRPC," said Colin Freund, CEO of Modra Pharmaceuticals.
Out of the 62 patients enrolled in the second cohort, 31 received IV docetaxel and 31 were administered ModraDoc006/r at 20mg ModraDoc006 combined with 200mg ritonavir in the morning, 20mg ModraDoc006 with 100mg ritonavir in the afternoon ("20-20/200-100") in a bi-daily weekly dosing (BIDW) regimen. Notably, neutropenia was eliminated with ModraDoc006/r 20-20; 0% vs. 26% on IV docetaxel. Neuropathy was significantly reduced at 10% G1 only on ModraDoc006/r vs. 29% total (10% G1, 19% G2) on IV docetaxel. Incidence of alopecia was 23% on ModraDoc006/r vs. 42% on IV docetaxel. ModraDoc006/r vs. IV docetaxel demonstrated an overall response rate (ORR) of 39% vs. 29% respectively. Prostate-Specific Antigen (PSA) responses were also comparable at 48% vs. 50%. Gastrointestinal toxicities with ModraDoc006/r 20-20 remained mild and similar to IV docetaxel.
"Not only did ModraDoc006/r 20-20 eliminate neutropenia, a significant hurdle in the oral taxane space, while maintaining equivalent efficacy to IV docetaxel, it also dramatically reduced neuropathy and alopecia, side-effects that frequently complicate the lives of mCRPC patients undergoing chemotherapy," said Ulka Vaishampayan, MD, Principal Investigator of the study and Professor of Internal Medicine, Division of Hematology/Oncology at the University of Michigan. "These encouraging data provide a compelling rationale for conducting further development in a pivotal study with ModraDoc006/r to further investigate its potential. ModraDoc006/r 20-20 will be applicable to a broader mCRPC patient population that may not have access to or tolerate more traditional IV chemotherapy regimens. The convenience of oral administration with maintained efficacy makes it an attractive option that is likely to improve prostate cancer outcomes."
The open label 1:1 randomized study compared ModraDoc006/r 20-20 in a BIDW schedule with IV docetaxel 75 mg/m2 administered in 21-day cycles. Participating patients had mCRPC with a performance status of 0-1 and had not received prior chemotherapy for mCRPC. All patients received 5 mg oral prednisone twice daily. The primary endpoint of the study was radiographic progression free survival (rPFS) per PCWG-3 criteria. Secondary objectives included ORR, PSA-PFS, time to skeletal related events, disease control rate, duration of response and safety assessments.
Session: Genitourinary Cancer?Prostate, Testicular, and Penile
Poster Title: A Phase 2 randomized study of oral docetaxel plus ritonavir (ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer (mCRPC)
Presenter: Ulka N. Vaishampayan, MD | University of Michigan
Location: In-Person & Live Stream | Arie Crown Theater
Session Date and Time: June 6, 2022 from 16:30 CDT ? 18:00 CDT
Abstract Number: 5016
Poster Number: 200
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 therapy 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 transform taxane therapy by developing therapies that are less toxic, at least as effective and can be taken at home in tablet form. The Company's goal is to dramatically improve the therapeutic outcomes and everyday lives of the hundreds of thousands of cancer patients undergoing taxane therapy worldwide. Modra's lead program completed a Phase 2b clinical study in prostate cancer, resulting in positive date further supporting the delivery, bioavailability and tolerability of its novel approach.
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