ABIO Joins Battle Against COVID-19, ERYP On Watch, LPCN To Report NASH Study Results In Q1

Today’s Daily Dose brings you news about ARCA biopharma’s progress related to its COVID-19 drug candidate, ADC Therapeutics’ submission of Loncastuximab tesirine BLA, BridgeBio’s initiation of ADH1 study, ERYTECH Pharma’s anticipated milestones, and the progress in Lipocine’s NASH trial.

Read on…

1. ARCA biopharma Joins battle Against COVID-19

ARCA biopharma Inc. (ABIO) has submitted an Investigational New Drug application with the FDA, seeking clearance to initiate a phase IIb/III trial of AB201 for the treatment of patients hospitalized with COVID-19.

AB201 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections.

If cleared, the company anticipates initiating the phase IIb portion of the trial as early as the fourth quarter of this year.

ABIO closed Monday’s trading at $4.63, down 10.62%. In after-hours, the stock was up 2.59% at $4.75.

2. ADC Therapeutics Submits Lonca BLA

ADC Therapeutics SA (ADCT) has submitted a Biologics License Application to the FDA for Loncastuximab tesirine for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.

Loncastuximab Tesirine or Lonca is an antibody-drug conjugate composed of a humanized monoclonal antibody that binds to human CD19, a protein. While the expression of CD19 in healthy tissue is restricted, it is highly expressed in a range of B-cell hematological tumors, including certain types of lymphoma and leukemia.

The BLA submission is based on data from a pivotal phase II trial, dubbed LOTIS 2, in which Loncastuximab Tesirine demonstrated an overall response rate of 48.3% and a complete response rate of 24.1%.

The LOTIS 2 trial involved patients with relapsed or refractory diffuse large B-cell lymphoma following two or more than two lines of prior systemic therapy.

The company has also initiated LOTIS 5, a phase III confirmatory clinical trial of Lonca in combination with Rituximab, which is intended to support a supplemental BLA for Loncastuximab Tesirine to be used as second-line therapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

ADCT closed Monday’s trading at $45.25, down 0.55%.

3. BridgeBio Pharma On Track

BridgeBio Pharma Inc.’s (BBIO) affiliate Calcilytix Therapeutics Inc. has initiated a phase II single-center study of Encaleret for Autosomal Dominant Hypocalcemia Type 1 (ADH1) at the National Institutes of Health.

ADH1 is a rare, inherited disease caused by gain-of-function mutations in the calcium-sensing receptor (CaSR) resulting in abnormally low serum calcium and high urine calcium and a range of debilitating symptoms. Currently, there are no approved therapies for ADH1.

The phase II trial is designed to enroll up to 16 individuals with ADH1 and will evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics, and efficacy of single and multiple doses of Encaleret.

The topline proof-of-concept results from this phase II study are expected next year.

BBIO closed Monday’s trading at $39.66, down 6.00%.

4. ERYTECH to Report Final Phase II ALL Data by Year-end

ERYTECH Pharma (ERYP) has a couple of events to keep an eye on in the coming months.

The company expects interim superiority analysis of its pivotal phase III clinical trial of lead product candidate, Eryaspase, in second-line metastatic pancreatic cancer to be conducted in the first quarter of 2021.

The trial, dubbed TRYbeCA-1, has randomized more than 450 of the approximately 500 patients to be enrolled in the trial.

According to the company, the interim analysis can result in the trial being allowed to continue toward a final analysis, expected in the second half of 2021, or be concluded early if the trial successfully meets the primary endpoint of prolonging overall survival.

A phase II trial of Eryaspase in acute lymphoblastic leukemia (ALL) patients who developed hypersensitivity to pegylated asparaginase, dubbed NOR-GRASPALL-2016 trial, is ongoing. This study is sponsored by the Nordic Organization of Pediatric Hematology and Oncology (NOPHO).

Preliminary findings of the NOR-GRASPALL-2016 study reported in June this year suggested that Eryaspase achieved the target level and duration of asparaginase activity in the second-line acute lymphoblastic leukemia (ALL) patients. Hypersensitivity to asparaginase remains an important concern in the treatment of ALL patients. The final data from this study is expected by the end of 2020.

ERYP closed Monday’s trading at $7.30, up 3.40%.

5. Lipocine Awaits NASH Trial Results

Lipocine Inc. (LPCN) has completed enrollment in its phase II study of LPCN 1144 in confirmed non-cirrhotic non-alcoholic steatohepatitis subjects, dubbed LiFT.

The LiFT study, which has a treatment period of 38 weeks, has randomized 56 subjects 1:1:1 to two test arms and one placebo arm.

The company expects to report the primary endpoint, i.e., the top-line change in liver fat data measured by MRI-PDFF, in January 2021.

The company’s Tlando, an investigational testosterone replacement therapy, is still awaiting the FDA decision which was originally due on August 28, 2020.

LPCN closed Monday’s trading at $1.59, down 0.93%.

6. Stocks That Moved On No News

CorMedix Inc. (CRMD) closed Monday’s trading at $5.72, up 24.08%.

Sonoma Pharmaceuticals, Inc. (SNOA) closed Monday’s trading at $9.13, up 15.57%.

Humanigen Inc. (HGEN) closed Monday’s trading at $11.07, up 14.72%.

Wave Life Sciences Ltd. (WVE) closed Monday’s trading at $15.05, down 22.98%.

Pieris Pharmaceuticals Inc. (PIRS) closed Monday’s trading at $2.33, down 21.02%.

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