Galera Phase 2 Trial, And Other News: The Good, Bad And Ugly Of Biopharma

Galera Therapeutics Advances Mid Stage Clinical Trial of GC4419

Galera Therapeutics Inc. (GRTX) reported that it has completed the process of patient enrollment for its Phase 1b/2a clinical trial of avasopasem manganese or GC4419. The drug candidate is being assessed for safety and anti-cancer efficacy when used in combination with stereotactic body radiation therapy in patients suffering from locally advanced pancreatic cancer.

Phase 1b/2a trial is a randomized study which will focus on determining progression-free survival and overall response rate of the drug candidate. It will also evaluate the safety and tolerability of GC4419 to determine the recommended dose of the drug candidate. Mel Sorensen, M.D., President and CEO of Galera said, “This pilot trial is the first to evaluate the anti-cancer effects of our dismutase mimetics in combination of SBRT in patients. We look forward to reporting topline data from this trial in the second half of 2020.”

Avasopasem Manganese is an investigational, highly selective small molecule superoxide dismutase (SOD) mimetic. It was initially developed for reducing radiation-induced severe oral mucositis. It aims to convert superoxide to hydrogen peroxide and oxygen rapidly and selectively. This process helps in safeguarding normal tissue from damages caused by radiation therapy. Unsupervised, such high level of superoxide may harm noncancerous tissues and may also lead to various side effects such as oral mucositis.

Avasopasem Manganese is currently being evaluated in the ROMAN trial for its impact on radiation-induced oral mucositis in head and neck cancer patients. The trial is a randomized, double blind, placebo-controlled Phase 3 study and involves nearly 450 patients. In a double-blind, randomized, placebo-controlled Phase 2b trial for the drug candidate, a statistically significant reduction in duration of severe oral mucositis was reported. The duration was reduced from 19 days to 1.5 days in the 90 mg treatment arm. This trial had 223 patients suffering from neck and head cancer.

Avasopasem Manganese is also in a Phase 2a trial stage for reducing the occurrence of radiation-induced esophagitis in lung cancer patients. There is also a pilot Phase 1/2 trial assessing the drug candidate in combination with stereotactic body radiation therapy for treating locally advanced pancreatic cancer patients. It has been given Fast Track and Breakthrough Therapy tags by the FDA for controlling SOM caused by radiotherapy.

Galera Therapeutics is a clinical-stage biopharmaceutical company. It mainly focuses on developing proprietary therapeutics for transforming radiotherapy in cancer. Its lead drug candidate is GC4419 which is the subject matter of multiple clinical trials.

Galera is also working on another drug candidate GC4711 for SBRT. This product candidate is past its Phase 1 trials involving healthy volunteers. The company plans to use the data gathered from GC4419 trials for further developing this drug candidate. Galera is looking to initiate a Phase 1b/2a trial of GC4711 in combination with SBRT for NSCLC. The drug candidate is also likely to be tested with SBRT for LAPC, provided the company yields positive results from its current SBRT GC4419 pilot Phase 1b/2a trial for the indication. Further, GC4711 is also being tested in oral formulation form in a Phase 1 trial in healthy volunteers.

Albireo Begins Enrollment in Phase 3 Clinical Trial of Odevixibat

Albireo Pharma Inc. (ALBO) reported that it has enrolled first patient in its Phase 3 clinical trial of Odevixibat. BOLD is a double-blind, randomized, placebo-controlled study. The trial seeks to assess the efficacy and safety of odevixibat in children suffering from the indication and who have undergone a Kasai procedure before age three months.

BOLD is the largest, prospective intervention trial ever conducted in biliary atresia. Patients included in the treatment arm will be administered with odevixibat and escalate to 120 μg/kg orally once daily for 24 months. The primary efficacy endpoint of the trial is related to improvement in the proportion of patients who are alive and have not undergone a liver transplant after two years of treatment compared to placebo.

The secondary endpoints of the trial include time to onset of any sentinel events, total bilirubin levels and serum bile acid levels. Ron Cooper, President and Chief Executive Officer of Albireo, “We look forward to continuing our work to realize the potential of odevixibat as a much-needed treatment option for patients across multiple cholestatic liver diseases with BOLD and our PEDFIC 1 Phase 3 trial of odevixibat in progressive familial intrahepatic cholestasis, which we continue to expect topline data from in mid-2020.” The trial aims to enroll nearly 200 patients across 75 sites globally.

Odevixibat is a highly potent and selective inhibitor of the ileal bile acid transporter. It is being developed to treat various liver ailments such as progressive familial intrahepatic cholestasis, Alagille syndrome and biliary atresia. The drug candidate is currently a part of the PEDFIC 1 Phase 3 clinical trial and BOLD Phase 3 clinical trial. The first trial is aimed at patients with PFIC while the latter focuses on patients with biliary atresia.

Bellerophon Therapeutics Initiates Phase 3 Clinical Study for INOpulse

Bellerophon Therapeutics Inc. (BLPH) announced that the company has initiated treating its patient in Phase 3 clinical study of INOpulse. The trial aims to evaluate the potential of inhaled nitric oxide therapy for treating COVID-19. Bellerophon’s Investigational New Drug application for the Phase 3 study was accepted by the FDA in May 2020.

The Phase 3 study is a randomized, placebo-controlled trial and was earlier known as PULSE-CVD19-001. The trial will assess the efficacy and safety of INOpulse therapy in patients diagnosed with COVID-19 who require supplemental oxygen. Fabian Tenenbaum, CEO of Bellerophon Therapeutics said, “The initiation of the Phase 3 study is an important milestone that will enable us to further evaluate the potential of INOpulse to address urgent medical needs for those impacted by COVID-19 throughout the country.” The company is collaborating with leading US hospitals for patient enrollment.

Nitric oxide is a naturally produced molecule as part of the immune response to pathogens. It plays important role in controlling viral replication. The proprietary INOpulse delivery system is an investigational system. It mainly aims to deliver nitric oxide in a targeted, pulsatile manner, ensuring precise drug delivery. The system also facilitates the use in outpatient setting.

Prior data has shown that nitric oxide may prove to be beneficial in treating SARS-CoV by controlling viral replication. COVID-19 is caused by the SARS-CoV-2 coronavirus, which is significantly similar to the severe acute respiratory syndrome related coronavirus. Further, nitric oxide has been found to be useful in decreasing the need for ventilation support and improving arterial oxygenation. It is also conducive to prevent the proliferation of pneumonia lung infiltrates.

Bellerophon Therapeutics is a clinical-stage biotherapeutics company. It is working on several product candidates for different indications using its INOpulse® program.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Source: Seeking Alpha

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