POINT Biopharma completes randomization in PNT2002’s phase 3 SPLASH trial
Canadian Manufacturing
Enrollment for the randomization phase of SPLASH completed prior to EOY 2022, meeting previous guidance.
INDIANAPOLIS — POINT Biopharma Global Inc., a company accelerating the development, and global access to radiopharmaceuticals, announced the completion of enrollment for the randomization phase in the pivotal phase 3 SPLASH trial, on schedule and meeting previous guidance.
SPLASH is a multi-centre, randomized, open label assessment of 177Lu-PNT2002 in participants with PSMA-expressing metastatic castration resistant prostate cancer who have progressed on androgen receptor pathway inhibitor therapy and refuse, or are not eligible for, chemotherapy.
Enrollment for randomization was completed on schedule with more than 390 participants randomized across 55 SPLASH trial sites in North America, Europe, and the United Kingdom.
“We are proud to have reached this important milestone for the PNT2002 program,” said Jessica Jensen, Executive Vice-President, Clinical Development of POINT Biopharma. “Our incredibly talented cross-functional team collaborated tirelessly to ensure that, despite the extraordinary circumstances of a pandemic, POINT’s first phase 3 global trial remained on track. Our success is a testament to both the expertise of our team and the level of enthusiasm for radioligand therapy in the oncology community.”
On November 14, 2022, POINT announced a set of collaboration agreements with Lantheus Holdings Inc., related to POINT’s PNT2002 and PNT2003 product candidates, which closed on December 20, 2022.
Under the agreements, POINT will fund and complete its phase 3 SPLASH trial for PNT2002, following which Lantheus will file the New Drug Application (NDA) in collaboration with POINT.
For PNT2003, POINT recently received the OZM-067 clinical trial data sets from the trial sponsor. POINT will facilitate the analysis of the data sets. Lantheus will prepare and submit the regulatory filings in the U.S.
The companies have formed joint steering committees to oversee the clinical studies, regulatory filings, manufacturing, and commercial readiness for both PNT2002 and PNT2003. POINT will develop commercial production capacity and manufacture clinical and commercial supply for both PNT2002 and PNT2003. Lantheus has the rights to commercialize both assets post regulatory approval, excluding certain Asian territories.
