Prime Highlights-
- The US FDA has granted Breakthrough Therapy designation to Clarity Pharmaceuticals’ 64Cu-SAR-bisPSMA.
- The agent helps doctors find prostate cancer lesions in men whose PSA levels rise after treatment.
Key Facts-
- In the Co-PSMA trial, the agent detected 63 lesions, compared with 24 for an approved agent.
- Topline results from two Phase 3 studies are expected in the first half of 2027.
Background-
Doctors use the agent in positron emission tomography (PET) scans to spot PSMA-positive lesions. It is meant for men with prostate cancer who show signs of biochemical recurrence, which means their PSA levels rise after treatment.
The designation helps speed up the development and review of promising treatments for serious conditions. It also gives the company closer guidance and more frequent contact with FDA reviewers.
Strong trial data supports the decision. In the Phase 2 Co-PSMA trial, researchers compared the agent head-to-head with an approved agent in 50 men. 64Cu-SAR-bisPSMA found 63 lesions, compared with 24 for the approved agent. It also produced positive scans in 78% of patients, against 36%. The results changed treatment plans for 44% of the patients.
Alan Taylor, PhD, Executive Chairperson of Clarity, called the designation “one of the most significant milestones in our prostate cancer program to date.”
Clarity now runs two Phase 3 registrational studies, AMPLIFY and CLARIFY, in the US and Australia. Both have finished enrolling patients. The company expects topline results in the first half of 2027, and these studies aim to support future FDA applications.
