Blueprint Medicines’ solid tumor med BLU-222 is back from the drawing board after the FDA lifted a partial clinical hold that has been in place since mid-February.
The phase 1/2 VELA trial is back on track, the Cambridge, Massachusetts-based company said in an after-market release Tuesday. The hold was placed due to visual adverse events, such as light sensitivity and blurred vision, which were mostly grade 1 events except for one more serious grade 3. All of these events were resolved with a reduction or interruption of dosing, Blueprint said in February.
Now, the company will work with the trial sites to get enrollment underway again, as the hold lift is effective March 28. Blueprint said in Tuesday’s release that patients who were already enrolled in the trial have continued dosing.
The company worked with the FDA to resolve the issues by updating adverse event monitoring and management procedures. Blueprint plans to present initial dose escalation data from the study in the second quarter of 2023, which is consistent with previous guidance.
The VELA trial began in February 2022 to test doses of BLU-222 ranging from 50 mg up to 800 mg. Over 360 patients with solid tumors are expected to be recruited. The grade 3 event occurred in a patient who received a 600-mg dose.
BLU-222 is being tested in solid tumors, including breast cancer, ovarian cancer and gastric cancer, according to the VELA study’s entry in the National Institutes of Health clinical trials database.
DiaMedica Therapeutics announced its own update on a clinical hold affecting the company yesterday, but, in this case, the biotech remains in limbo for the time being. The FDA placed a hold on the phase 2/3 trial of the acute ischemic stroke therapy DM199 back in July 2022 in response to three cases of unexpected low blood pressure. Communication between the company and the regulator have continued since, with the FDA recently indicating that the protocol for a requested in-use trial of the therapy appeared “reasonable,” DiaMedica said in its full-year earnings report.
“With the completion of the in-use study at hand, we look forward to continuing to work with the FDA to confirm that we have addressed all issues of the clinical hold and then prepare our complete response requesting a lifting of the clinical hold,” CEO Rick Pauls said in the release.