On April 22nd, Silkim Pharma filed a pre-Investigational New Drug (PIND) meeting request with the U.S. Food and Drug Administration (FDA) for its drug candidate CORONZOT in the treatment of COVID-19 patients with moderate-to-severe symptoms.
On May 5th, FDA responded positively to the meeting request and on May 16th Silkim Pharma received FDA’s written response (meeting summary). The response includes FDA’s advice and guidance on the planned clinical study. Following FDA’s advice, Silkim Pharma plans to submit an IND application for CORONZOT to be evaluated as a potential addition to the current standard of care treatment for COVID-19.
“We thank the FDA for reviewing our application in such a short time, for accepting our meeting request and for providing the guidance we requested, and we look forward to finalizing the IND and then moving towards conducting clinical studies of CORONZOT for COVID-19. The scientific and medical literature, our experience in inflammatory pathologies, and the favorable safety experience of our drug candidate support the exploration of CORONZOT as a therapy for COVID-19 patients who are hospitalized with moderate to severe symptoms,” stated Silkim Pharma CEO Dror Chevion.
When the body is under attack by the coronavirus, the exaggerated reaction of the body’s immune system, triggered by the virus, is deadly! This phenomenon is called Cytokine Release Syndrome, or “Cytokine Storm”, progressing to hyper-inflammatory condition, often with life-threatening pulmonary involvement, causing the life-threatening Acute Respiratory Distress Syndrome (ARDS) and cardiac failure
“Coronzot”, a novel drug, was recently developed by Silkim Pharma Ltd., to address the exaggerated reaction of the body’s immune system, triggered When the body is under attack by the Coronavirus. Coronzot employs a novel mechanism based on sequestration of the labile iron, introducing an ion of gallium or zinc, in limited amounts, instead.
Application of Coronzot renders a quadruple effect against the disease:
(i) Suppressing production of pro-inflammatory cytokines and restrains virus multiplication.
(ii) Inhibits activity of viral lungs- and heart-attacking proteins, thus mitigating ARDS, lungs and heart failure;
(iii) Insertion of gallium instead of iron inhibits replication of viruses and promotes the apoptosis of already invaded cells;
(iv) Release of zinc directly to the site of infection suppressing the pro-inflammatory reactions and inhibiting activity of enzymes essential for virus invasion, pathogenesis, replication and virulence.
About Sillkim Pharma Ltd
Silkim Pharma Ltd. was established in 2017 on the basis of co-founder, Professor Motty Chevion ‘s work at the Hebrew University. He and co-inventors developed a family of non-steroidal chemical complexes, made of components approved for clinical use. The company licenced the right to commercialize the technology from Yissum, the TTO of the Hebrew University. These New Chemical Entities constitute a protected PLATFORM of DRUGS, with proven efficacy and complete safety, for treatments of multiple indications. The PLATFORM members show 3 synergistic Mechanisms of Action, extensively tested in animal models of human diseases (and anecdotal human cases).
The company is looking for additional information.
More further information – Dror Chevion, CEO Edror at silkim.com http://www.silkim.com/
Source – Silkim Pharma linkedin site