AMSTERDAM–(BUSINESS WIRE)– Modra Pharmaceuticals (“Modra”) today announced final results from the lower dose cohort in the Company’s Phase 2b trial evaluating its oral taxane drug, ModraDoc006/r, in patients with metastatic castration-resistant prostate cancer (mCRPC) versus standard of care Docetaxel IV chemotherapy 75 mg/m2 Q3W. ModraDoc006/r is an oral tablet formulation of docetaxel co-administered with ritonavir, a booster agent that improves bioavailability. The lower dose of 20-20/200-100 mg demonstrated a significantly improved safety profile compared to IV docetaxel while maintaining efficacy levels. Based on these encouraging results, this optimal dose was selected for Modra’s planned pivotal Phase 3 trial in patients with mCRPC. Phase 2b data will be presented in a “poster discussion” presentation at the 2022 ASCO Annual Meeting, June 3-7.

The detailed analysis of the low-dose cohort demonstrated that we can further improve the safety profile of ModraDoc006/r without compromising potency, making it a very attractive option for delivering chemotherapy. Now, with the optimal dosage of ModraDoc006/r selected, we are well positioned to enter Phase 3 clinical trials and take a step closer to providing a safer, effective and more convenient alternative to IV chemotherapy. patients living with mCRPCsaid Colin Freund, CEO of Modra Pharmaceuticals.

Of the 62 patients included in the second cohort, 31 received docetaxel IV and 31 received ModraDoc006/r at 20 mg of ModraDoc006 associated with 200 mg of ritonavir in the morning, 20 mg of ModraDoc006 at 100 mg of ritonavir after -noon (“20-20/200-100”) in a twice-daily weekly (BIDW) dosing regimen. Notably, neutropenia was eliminated with ModraDoc006/r 20-20; 0% versus 26% on docetaxel IV. Neuropathy was significantly reduced to 10% G1 only on ModraDoc006/r versus 29% overall (10% G1, 19% G2) on docetaxel IV The incidence of alopecia was 23% on ModraDoc006/r versus 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 barrier in the oral taxane space, while maintaining equivalent efficacy to IV docetaxel, but it also significantly reduced neuropathy and alopecia, effects side effects that frequently complicate the lives of mCRPC patients undergoing chemotherapy,” said Ulka Vaishampayan, MD, the study’s principal investigator and professor of internal medicine, Division of Hematology/Oncology at the University of Michigan. “These encouraging data provide compelling rationale for continued development in a pivotal study with ModraDoc006/r to further investigate its potential. ModraDoc006/r 20-20 will be applicable to a broader population of mCRPC patients who may not cannot access or tolerate more traditional IV chemotherapy regimens.The convenience of oral administration with sustained efficacy makes it an attractive option with the potential to improve prostate cancer outcomes.

The open-label randomized 1:1 study compared ModraDoc006/r 20-20 in a BIDW regimen with docetaxel IV 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 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 included ORR, PSA-PFS, time to skeletal events, rate of disease control, duration of response, and safety assessments.

Presentation details

Session: Genitourinary cancer – prostate, testicle and penis

Poster title: A Randomized Phase 2 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 and Live Stream | Arie Crown Theater

Session date and time: June 6, 2022 from 4:30 p.m. CDT to 6:00 p.m. 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 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.

About ModraDoc006/r
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, at least as effective, and can be taken at home in pill 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.

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