Our phase 2 clinical trial for our lead product, rhu-pGSN, has begun with severe COVID19 patients.

Harnessing the Power

OF INNATE IMMUNITY

Combating Inflammation, Infection and Degenerative Disease with Breakthrough Discovery

We are a clinical stage private company focused on developing therapies for infectious, inflammatory and degenerative diseases through a portfolio built around plasma gelsolin technology and therapeutics. With our ability to provide a platform to replete plasma gelsolin that has been depleted, we are in a unique position to deliver therapeutics that have the potential to disrupt the way many diseases are treated today.

PATENTS

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COLLABORATORS

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MARKET POTENTIAL

OUR MISSION

To address medical issues previously thought to be out of reach -- preventing the damage caused by excess inflammation without suppressing the immune system.

Plasma Gelsolin Addresses Urgent Need

Chronic inflammation plays a central role in some of the most challenging diseases of our time. Restoring the body with a recombinant version of a naturally occurring plasma protein – plasma gelsolin — that becomes depleted in diverse infectious and non-infectious diseases has enormous potential to prevent debilitating and potentially lethal ravages of inflammation without compromising its essential function to fight infection and promote repair. This strategy has consistently reduced morbidity and mortality of animals challenged with acute infections, traumatic and chemical injuries, autoimmune disorders and with insults associated with chronic illnesses.

"The world will face another influenza pandemic – the only thing we don’t know is when it will hit and how severe it will be."

On March 11, 2020, after 118,000 cases reported globally and 4291 lives lost, WHO declared COVID-19 to be a pandemic.

“Inflammation has hit the big time. Over the past decade, it has become widely accepted that inflammation is a driving force behind chronic diseases that will kill nearly all of us. Cancer. Diabetes and obesity. Alzheimer’s disease. Atherosclerosis. Here, inflammation wears a grim mask, shedding its redeeming features and making sick people sicker.....”

"...more than 2.8 million antibiotic-resistant infections occur in the U.S. each year, and more than 35,000 people die as a result."

REGULATES INFLAMMATION

A local inflammatory response is essential for the healing process to take place at the site of injury and to fight infection. Plasma gelsolin's unique role is to modulate this necessary inflammatory response so that what was intended to be a mechanism of healing does not become an instrument of morbidity and death.

ACUTE AND CHRONIC DISEASE APPLICATIONS

Multiple disease applications --- $50 billion pipeline market opportunity. Lead program life-saving host-directed prevention of organ failure in severe pneumonia.

KEY COMPONENT OF INNATE IMMUNITY

Plasma Gelsolin is a key component of the innate immune system - the first line of defense against threats to the body. This innate system is not pathogen-specific and reacts equally well to a wide variety of organisms.

FIGHTS INFECTION/NON IMMUNOSUPPRESSIVE

FIGHTS INFECTION/NON IMMUNOSUPPRESIVE

Most agents which interfere with the inflammatory process cause immunosuppression in patients. Plasma gelsolin is unique in that it is not immunosuppressive. Recombinant human plasma gelsolin (rhu-pGSN) improves uptake and killing of gram-positive and negative antibiotic-resistant and sensitive bacterial strains.

BENIGN SAFETY PROFILE

Recombinant human plasma gelsolin has been manufactured to be identical to the natural human protein. As a result, it is not expected to result in serious side effects when supplementing the depleted protein. In confirmation of this, no serious side effects were identified in animal toxicology studies or four human studies when dosed either intravenously or by inhalation.

EXTENSIVE IP PORTFOLIO

Our original IP and know-how was licensed from a consortium of Harvard institutions and other collaborators resulting in 40 patents being granted globally to date. We have continued to develop our patent estate and have filed new IP in 2019-20. Plasma gelsolin will benefit from 12 years of biologics exclusivity in the US beginning at approval of the product and data exclusivity of 11 years in the EU.