Bonus BioGroup has completed a preliminary study of a new drug it developed to treat acute and life-threatening respiratory distress in COVID-19 patients, CEO Dr. Shai Meretzki told The Jerusalem Post.
The drug MesenCure, which consists of activated Mesenchymal Stromal Cells (MSCs) that are isolated from the adipose tissue of healthy donors, was found to reduce inflammation, promote the regeneration of the diseased lung tissue and alleviate respiratory and other symptoms in laboratory and animal models.
Initial results show that subjecting the MSCs to various biological, physical and chemical conditions has changed cellular attributes, which may be associated with greater anti-inflammatory potential.
Meretzki shared a laboratory image of a healthy lung, a sick lung and lung treated with MesenCure.
“The treated lung looks identical to the healthy lung – complete healing, complete prevention of damage to the lung,” Meretzki said.
The company has been working with MSCs for a decade from its Haifa headquarters, where it developed a tissue-engineered bone graft that is also based on MSCs. When the coronavirus outbreak started, Bonus started investigating the potential of MSCs to possibly reduce the “cytokine storm” in COVID-19 patients.
Accumulating evidence shows that many COVID-19 patients die because of an increase in the production of inflammatory molecules called cytokine, rather than the virus itself. When the immune system secretes too many cytokines, a so-called "cytokine storm" can erupt. Such an excessive immune response ravages healthy lung tissue, leading to acute respiratory distress syndrome or failure, and eventually death.
Meretzki said that MSCs are cells that are “found in every one of us; they are responsible for damage control and a variety of day-to-day activities.”
Bonus has so far tested MesenCure in several animal models, but Meretzki said the company hopes to launch clinical trials within a few months.
“Once we are doing clinical trials, our hope to be able to help a lot of patients suffering from COVID-19,” he said.
However, the company acknowledged that the expected timeline for the trial is "forward-looking" and several factors could change.
A press release published on the company’s website made clear that, “There is no certainty that these intentions will be realized, in whole or in part, among others, due to the dependence of third parties' actions that are not under the control of the company, the possibility of delay in obtaining relevant regulatory approvals and/or a change in the relevant conditions,” among other reasons.
Bonus is not the only company evaluating the benefit of MSCs in the fight against COVID-19. An article by the popular stem cell industry blog BioInformant said that the cells “have emerged at the forefront as a promising tool for the treatment of patients with coronavirus infection. This is because there is a solid foundation of scientific literature and early stage trials to support the use of MSCs for the respiratory distress and lung issues related to COVID-19.”
There are at least 20 ongoing stem cell trials for COVID-19, most of them using MSCs.
Israel’s Pluristem Therapeutics’ PLX cells therapy, which is also based on MSCs, has already been cleared by the US Food and Drug Administration for a Phase II study for the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome.
In-vitro and in-vivo evidence, as well as preliminary clinical evidence, suggests that PLX-PAD could provide an essential treatment for COVID-19. Last month, the company reported that six critically ill coronavirus patients at three different medical centers in Israel, who were considered high-risk for mortality, had been treated with its placenta-based cell-therapy product and survived.
Meretzki made clear that MesenCure is not a vaccination and does not attack the coronavirus, but rather would be used to prevent severe damage to the lungs that results from COVID-19. He said that he believes many tools will be used to treat patients in any second coronavirus wave, and MSCs will be one of them.
Moreover, he noted that if the drug proves effective in the treatment of lung infection, it could be used for other indications aside from coronavirus. According to the Forum of International Respiratory Societies, more than a billion people worldwide are suffering from inflammatory diseases of the lower respiratory tract, which cause an estimated 7.5 million deaths each year, Meretzki said.
“Bonus BioGroup employees are proud to take part in the global effort to fight COVID-19,” he said.