25 patient dosimetry and safety run-in met all pre-specified safety and efficacy criteria
Initiated patient enrollment in Canada with additional countries to begin enrolling in 4Q21
INDIANAPOLIS, Indiana, Sept. 23, 2021 - POINT Biopharma Global Inc. (NASDAQ: PNT), a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, today announced that the dosimetry and safety run-in of its Phase 3 SPLASH study evaluating PNT2002 for Metastatic Castrate Resistant Prostate Cancer (mCRPC) met all pre-specified criteria allowing for initiation of the randomization phase without changes to the study design.
“I would like to thank our team and partners for enabling the SPLASH trial’s randomization to begin ahead of schedule,” said Dr. Joe McCann, Chief Executive Officer of POINT Biopharma. “Due to their complex supply chains, radiopharmaceutical trials can be complex to administer. Our team and partners have done an amazing job of overcoming these difficulties, enabling the achievement of this SPLASH trial milestone. Based on the data generated to date, we believe that PNT2002 has the potential to be a novel, safe and effective option for mCRPC patients who currently have few approved therapeutic alternatives.”
The open-label safety and dosimetry lead-in dosed 27 patients with PSMA-expressing mCRPC who have progressed on novel anti-androgen therapy and are ineligible or averse to chemotherapy. This phase met all pre-specified criteria based on renal absorbed dose, clinical toxicity and preliminary efficacy. Data from the safety and dosimetry lead-in will be presented at an upcoming scientific conference. Enrollment for the randomization phase has commenced in Canada and will continue to expand to additional countries throughout North America, United Kingdom and Europe.
“As a practicing Uro-oncologist, I am strongly encouraged by our results and the potential for PNT2002 to address an unmet need in mCRPC - an aggressive disease where patients often have poor prognosis,” said Dr. Neil Fleshner, Chief Medical Officer and co-founder of POINT Biopharma. “I am grateful for the immensely positive support of all the physicians and patients that are participating in this clinical program, and look forward to the expected completion of the study in 2023."
The Phase 3 SPLASH study (NCT04647526) is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on Androgen receptor-axis-targeted therapies (ARAT) therapy and refuse or are not eligible for chemotherapy. The randomization phase of the study is expected to enroll approximately 400 patients across North America, Europe and the UK. Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide. Patients in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival (rPFS). Key secondary endpoints include overall response rate (ORR), overall survival (OS), and pharmacokinetics (PK). POINT anticipates meeting with regulatory agencies in North America, United Kingdom and Europe to gain alignment on requirements for planned submissions after data readout from the SPLASH trial.
Additional information on the Phase 3 SPLASH study can be found at https://www.splashtrial.com.
Forward Looking Statements
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