Clinical Catch-Up: December 23-27


With the holidays, it’s not surprising that it was a quiet week for clinical trial news. Nonetheless, some companies did have clinical trial stories to report. Here’s a look.

CytoDyn announced continued promising clinical data from its Phase Ib/II clinical trial of leronlimab for metastatic breast cancer. The drug is a CCR5 antagonist. Data continues to show no detectable circulating tumor cells (CTC) or putative metastatic tumor cells in the peripheral blood and additional reductions in CCR5 expression in cancer-associated cells at 11 weeks of treatment with the drug. And data from an emergency IND protocol in one MBC patients showed shrinkage of tumor via MRI after three weeks of treatment with the drug.

Progenics Pharmaceuticals announced positive topline data from its Phase III CONDOR trial of PyL in men with biochemical recurrence of prostate cancer. PyL is the company’s PSMA-targeted small molecule positron emission tomography (PET) imaging agent. The CONDOR trial is a prospective, multi-center, open label pivotal trial in 208 patients with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional imaging modalities. The patients were dosed and imaged with PyL at 14 locations in the U.S. and Canada. The trial met its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers.

Quantum Genomics launched the Phase III FRESH trial of firibastat in difficult-to-treat and resistant hypertension. The study is being run in partnership with Biolab Sanus Pharmaceuticals. The study will enroll 500 patients with resistant or difficult-to-treat hypertension. Firibastat is a BAPAI, a prodrug that delivers the EC33 product in the brain, a selective and specific inhibitor of Aminopeptidase A, which prevents the production of Angiotensin III in the brain.

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Spring Bank Pharmaceuticals stopped dosing and enrolling patients in its Phase IIb CATALYST clinical trials. The trial was evaluating inarigivir soproxil 400 mg for chronic hepatitis B virus (HBV). The company also halted all of the drug in chronic HBV. The trial was halted because of clinical findings in the CATALYST 2 trial showing that three patients had evidence of hepatocellular dysfunction and an elevated alamine transaminase (ALT) potentially consistent with liver injury instead of immune flares. The company is working to analyze the data to better understand the findings and potential causes and more safety data in the 100 patients who have received the drug at this dose so far.

Iterum Therapeutics completed patient enrollment in its Sulopenem for Resistant Enterobacteriaceae (SURE) 1 clinical trial in uncomplicated urinary tract infections (uUTI). The multi-center, double-blind trial will measure efficacy, tolerability, and safety of oral sulopenem/probenecid for uUTI in adult women. Patients are randomized to either receive oral sulopenem/probenecid twice a day for five days or oral ciprofloxacin twice daily for three days.

Prevail Therapeutics received a go-ahead from the FDA for its IND application for PR001 for neuronopathic Gaucher disease (nGD). The IND had previously been put on clinical hold by the agency, which has now been removed. The planned Phase I/II clinical trial for nGD patients will start at a dose higher than originally proposed. It starts to initiate patient enrollment during in the first half of 2020. Type 2 Gaucher disease is the more severe form of nGD, which is seen in infancy and rapidly progresses into neurodegeneration leading to death in infancy or early childhood. The company also plans to launch a Phase I/II trial for Type 3 Gaucher disease in the second half of 2020 under the same nGD IND.

Innovation Pharmaceuticals announced that patient screening for its Phase I trial in healthy volunteers for delayed release tablets for colonic delivery of oral Brilacidin for Ulcerative Colitis is expected to start in early January. The UK’s Medicines and Healthcare products Regulatory Agency granted Innovation approval to start the Phase I trial.

Cellect Biotechnology was given the greenlight to initiate a clinical trial of the ApoGraft technology for haploidentical bone marrow transplantations. The trial is in collaboration with Washington University School of Medicine in St. Louis. A total of 18 patients are planned for the initial phase, with enrollment expected to start in the first half of 2020.

Phathom Pharmaceuticals initiated its Pivotal Phase III trial of vonoprazan in Helicobacter pylori (H. pylori) infection. The trial is dubbed PHALCON-HP. It will evaluate vonoprazan in combination with amoxicillin (vonoprazan dual therapy) and vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) against H. pylori.

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