Humanetics to use federal grant to advance BIO 300 as IPF treatment

Therapy candidate will be tested for effectiveness in easing lung scarring

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by Mary Chapman |

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A scientist wearing gloves and safety goggles works with a petri dish in a lab alongside a rack of test tubes.

The pharmaceutical company Humanetics will use a federal grant to fund a series of studies aimed at advancing the development of BIO 300 for idiopathic pulmonary fibrosis (IPF) — for one, testing the treatment candidate for its effectiveness in easing lung scarring, or fibrosis.

BIO 300 is thought to prevent and lessen the effects of acute and chronic inflammatory pulmonary disorders, including radiation toxicities.

The grant was awarded by the National Heart, Lung, and Blood Institute (NHLBI).

“We intend to demonstrate that the drug can be used to reduce devastating lung scarring in patients with IPF,” Ronald Zenk, Humanetics’ president and CEO, said in a company press release.

“In doing so, BIO 300 has the potential to significantly improve quality of life for these patients,” Zenk added.

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Thought to affect an estimated 3 million individuals globally, IPF is a progressive lung disease that causes lung inflammation and scarring, in addition to other symptoms, such as shortness of breath.

While there are IPF therapies that have been approved based on their ability to slow lung function decline, such treatment has not been shown to significantly ease disease symptoms nor enhance patients’ life quality, according to Humanetics.

The small business innovation research grant from the NHLBI, part of the National Institutes of Health, will enable Humanetics to evaluate BIO 300’s ability to reduce fibrosis in a preclinical IPF model.

The expectation is that these studies will serve as the foundation for future research to support the translation of BIO 300 toward a potentially transformative IPF treatment. According to Humanetics, if cleared to be used in the clinic, BIO 300 could potentially change IPF’s current treatment landscape.

BIO 300 was discovered by U.S. Department of Defense scientists seeking to develop radioprotective medicines for the military, according to Humanetics. The company now is developing the therapy as a medical countermeasure to shield the human body from harm resulting from ionizing radiation. It’s also expanded its potential applications into cancer radiation therapy, COVID-19, and other inflammatory pulmonary disorders.

Data from a recently completed Phase 1b/2a clinical trial (NCT02567799), which tested BIO 300 in patients with non-small cell lung cancer receiving chemoradiotherapy, indicated that the therapy was safe and well-tolerated. Patients receiving BIO 300 also experienced fewer side effects associated with chemoradiotherapy, while still achieving favorable tumor treatment responses. Altogether, the study’s findings supported further investigation of BIO 300 as an effective radioprotector.

The safety and efficacy of BIO 300 also are being evaluated in an ongoing Phase 2 clinical trial (NCT04482595) in individuals hospitalized with acute respiratory disease syndrome caused by COVID-19. These patients continue to experience respiratory complications associated with long COVID after being discharged.

Humanetics noted that BIO 300’s therapeutic effect on radiation-mediated lung tissue injury, along with its potential to reduce long-term pulmonary damage in COVID-19 patients, could prospectively translate to clinical benefits in IPF.

The amount of the grant was not disclosed.