Seagen, Anebulo and ANeuroTech Start July with a Bang

2022-07-05

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)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 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. Anebulo Drug Succeeds in Reversing Acute Cannabinoid Intoxication As the United States moves slowly toward loosening restrictions on the use of cannabinoids, clinical trials investigating potential toxicity levels become more imperative. Anebulo Pharmaceuticals, Inc. is one such company taking an interest in this topic. An ongoing Phase II study is evaluating whether ANEB-001, one of the company’s treatment candidates, might be the answer needed in the event that a patient intakes toxic levels of psychoactive cannabinoids that lead to a condition called acute cannabinoid intoxication (ACI). Positive topline results for this trial were published Tuesday, demonstrating tolerability and efficacy as the treatment reverses feelings of “highness” in patients and a successful primary endpoint measurement. After treatment with 50 mg of ANEB-001, 90% of the patients no longer felt high. After a higher dosage of 100 mg, 70% of patients no longer felt high. These ratios have increased significantly compared to the placebo group, in which only 25% of participants had resolved symptoms of ACI. Additional measurements evaluated central nervous system functions such as alertness and heart rate. The trial is double-blinded and randomized. “The number of individuals with cannabinoid-related intoxication visiting our emergency departments is clearly on the rise,” Dr. Andrew Monte M.D., Ph.D., professor of emergency medicine & medical toxicology at the University of Colorado’s Denver-Anschutz Medical Center said. “Patients are coming from multiple settings including first-time users taking small doses of THC, adults and children inadvertently ingesting powerful THC gummies, and regular users unintentionally overdosing on new and more powerful THC products. Introducing an effective cannabinoid antidote into our treatment options would represent a significant improvement in how we can manage these patients.”