Development Programs

Promising Clinical Data

Across Multiple Indications

BIO-11006 is a novel patented peptide that inhibits the MARCKS protein. Phase 2 clinical trials have been completed with BIO-11006 in ARDS, COPD, and NSCLC, supporting safety and efficacy in these potential indications.

BIO-11006

  Preclinical

    Phase 1

 Phase 2

Phase 3

Acute Respiratory Distress Syndrome (ARDS)

ARDS is a life-threatening condition causing widespread capillary leakage and inflammation of the lungs. Breathing becomes difficult and oxygen cannot get into the body. Treatment options for ARDS are limited beyond mechanical ventilation and approximately 40 percent of ARDS patients do not survive. Globally, ARDS affects over 3 million people a year. In the U.S., approximately 240,000 individuals suffer from ARDS annually.

ARDS can be caused by a variety of insults to the lungs including bacterial and viral pneumonia, sepsis, smoke inhalation, aspiration, and, most recently, the COVID-19 virus. These conditions cause the movement of inflammatory cells, including white blood cells (e.g. neutrophils), from the tissue and blood stream into the lung. Once in the lung, these cells release pro-inflammatory molecules called cytokines; this “cytokine storm” leads to ARDS.

Activated MARCKS Protein is critical for inflammatory cells to move to the injured lung. BIO-11006 inhibits activation of MARCKS Protein to reduce the influx of inflammatory cells into the lung and reverse ARDS.

Phase 2 Study in ARDS

A Phase 2 study (NCT03202394) assessed the safety and efficacy of BIO-11006 compared to a placebo (half normal saline) in 38 patients with ARDS. Safety of BIO-11006 was confirmed when administered at a dose of 125 mg BID for up to 28 days.

Rapid improvements in oxygenation were observed in patients receiving BIO-11006 compared to the control group, together with decreases in pro-inflammatory cytokines. At 28 days, there were 7 deaths (37%) in the placebo arm and 4 deaths (21%) in the BIO-11006 treatment arm, a 43% reduction in mortality.

Average Pa02/Fi02 Ratio (% of Baseline)

PaO2 = partial pressure of oxygen; Fi02 = fractional inspired oxygen

Chronic Obstructive Pulmonary Disease (COPD)

COPD is a common lung disease affecting approximately 16 million people in the United States. In addition to its high mortality, COPD causes a great deal of morbidity, including chronic cough, chronic shortness of breath, exercise intolerance, and recurrent hospitalizations for exacerbations. COPD has many causes ranging from environmental or work exposures to air pollutants to genetic disorders, but the most common cause of COPD is smoking.

Mucus production is a central feature of lung health in persons with COPD. Overproduction of mucus compromises lung function and allows for the growth of bacteria that causes COPD exacerbations. BIO-11006 has demonstrated the ability to improve lung function in clinical studies with COPD patients.

Phase 2 Study in COPD

A Phase 2 dose-escalation study (NCT00648245) assessed the safety and effectiveness of BIO-11006 inhalation solution versus a placebo (half normal saline or HNS) in treating overproduction of mucus and inflammation in 172 COPD patients. Four doses of BIO-11006 or HNS were administered by nebulization for 21 days to 5 cohorts. The 75 mg BID dose appeared to be the most effective dose by increasing the proportion of trough FEV1 responders.

In addition to demonstrating a favorable safety profile, BIO-11006 demonstrated improvement in lung function.

Responders ≥ 100 mL Increase in FEV1 L/s

FEV1 = Forced Expiratory Volume in 1 Second

Non-Small Cell Lung Cancer (NSCLC)

NSCLC is the most common type of lung cancer and lung cancer is the leading cause of cancer-related death in the United States. NSCLC is any type of epithelial lung cancer other than small cell lung cancer (SCLC). The most common forms of NSCLC are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Other NSCLC types present less frequently. Smoking is the leading risk factor for developing NSCLC.

Phase 2 Study in NSCLC

A Phase 2 study (NCT03472053) evaluated the safety and efficacy of BIO-11006 in 60 NSCLC patients who were not candidates for curative surgery, radiation, or immunotherapy and who were also receiving Pemetrexed and Carboplatin as standard of care (SOC).

BIO-11006 decreased metastasis and tumor progression and increased the overall response rate and survival in patients with advanced NSCLC. All surviving BIO-11006 patients (30% of patients from start) exhibited a partial response or stable disease at 12 months, statistically significant compared to SOC alone (p=0.029).

Disease Control Rate (DCR)

DCR includes Complete Response, Partial Response, and Stable Disease

Potential Expansion Indications

Biomarck is collaborating with researchers to investigate the safety and efficacy of BIO-11006 in patients with recurrent osteosarcoma or Ewing’s sarcoma. The Phase 2 clinical study will enroll up to 10 participants aged 5 to 21 (NCT04183062).

In addition, in vivo data demonstrate that BIO-11006 and other peptides in the Biomarck portfolio inhibit inflammation in dermatology and ophthalmology models. Potential indications include uveitis, dry eye, atopic dermatitis, and psoriasis.