Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug.
Positive clinical data from pharmaceutical companies Seagen and Anebulo were announced Tuesday, along with an announcement of support from the U.S. Food and Drug Administration for ANeuroTech’s innovative new treatment for major depressive disorder (MDD).
Seagen’s Touts Positive Phase II Data in Colorectal Cancer
Seagen’s open-label Phase II MOUNTAINEER trial has produced positive full results. The trial was designed to investigate the safety and efficacy of Tukysa (tucatinib) when administered alongside trastuzumab, in patients with HER2-positive metastatic colorectal cancer (mCRC). The published results represent follow-up data from 84 patients who received the dual treatment. The patients showed a median duration of response at 12.4 months, and a 38.1% confirmed objective response rate. The median progression-free survival duration observed was 8.2 months.
“This study has shown the benefits of dual-HER2 inhibition with tucatinib and trastuzumab in patients with HER2-positive metastatic colorectal cancer, including many whose cancer had spread to the liver or lungs before joining the trial,” Roger Dansey, M.D., Seagen’s interim CEO and chief medical officer said. “We believe this chemotherapy-free combination may play an important role in addressing the unmet needs of patients with this disease.”
Patients with mCRC currently have limited treatment options. Seagen intends to file a supplemental New Drug Application for Tukysa to bring a chemotherapy-free option to patients.
ANeuroTech’s MDD Drug Receives Positive FDA Feedback
ANeuroTech also kicked off July with a bang. The company’s Phase IIIb development trial of ANT-01, a drug being developed for MDD, has received positive feedback from the FDA after a pre-investigational new drug (IND) application meeting. The trial will assess the safety and efficicay of ANT-01 combined with a first-line antidepressant versus placebo.
Existing treatments for this disorder come with the possibility of a wide range of negative side effects but if ANT-01 reaches the commercial market, patients would have access to a treatment that has little to no side effects. The treatment is a reduced dose of pipamperone dihydrochloride, an antipsychotic that is typically prescribed at a high dose for patients with psychotic conditions. Notably, this trial stands out with a unique secondary endpoint that tracks a participant’s improvement or decline in feelings of pleasure and cognitive function.
“ANT-01 has the potential to change the treatment paradigm for the ~190 million patients worldwide with MDD who are not currently helped by initial treatment with antidepressants,” Dr. Rudi Pauwels, executive chairman of ANeuroTech said.
An IND application filing for ANT-01 is anticipated in late 2022, and ANeuroTech intends to apply for Fast-Track Designation for the treatment.
