FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

PALM BEACH, Fla., Jan. 21, 2021 /PRNewswire/ -- Most of the news on advances for Covid-19 tend to focus on vaccines, however treatments are just as important. While vaccines can stop people from contracting Covid and becoming seriously ill, treatments will still be needed for those who already have it. Having an effective treatment would, in essence, make coronavirus a milder disease. If it stopped people who were admitted to hospital from needing ventilation, then there would be less risk of intensive care units in hospitals being overwhelmed. An article in the BBC said that there are three broad approaches being investigated: Antiviral drugs that directly affect the coronavirus's ability to thrive inside the body; Drugs that calm the immune system (severe Covid-19 is caused by patients' immune systems overreacting and damaging the body); and Antibodies that can target the virus, taken from either survivors blood plasma or made in a lab. It is possible that different drugs will work better at different stages - such as antivirals at the beginning and immune drugs in late-stage diseases. Combinations of therapies are also being investigated.   Active Companies in the markets today include BetterLife Pharma Inc. (OTCQB: BETRF) (CSE: BETR),  COMPASS Pathways plc (NASDAQ: CMPS), MindMed (OTCQB: MMEDF) (NEO: MMED), CytoDyn Inc. (OTCQB: CYDY), Synairgen plc (OTCPK: SYGGF).

Recently, the FDA authorized the use of monoclonal antibodies for Covid-19 treatments. It said: "Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses. Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus' attachment and entry into human cells."  It continued: "The FDA remains committed to advancing the nation's public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," said FDA Commissioner Stephen M. Hahn, M.D. "As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments." 

BetterLife Pharma Inc. (OTCQB: BETRF) (CSE: BETR) BREAKING NEWS:  BetterLife Selects CRO to Conduct Clinical Trials for AP-003 in COVID-19 Cases in Indonesia - BetterLife Pharma Inc. ("BetterLife" or the "Company"), an emerging biotech focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, is pleased to announce that it has engaged Equilab International to manage the upcoming clinical trials for its proprietary formulation of Interferon alpha2b (AP-003) in mild to moderate cases of COVID-19.

BetterLife believes that its inhaled IFN-α2b, AP-003, could lessen the severity and duration of COVID-19 and decrease the need for hospital admissions.

Jakarta-based Equilab (http://www.equilab-int.com) is an internationally recognized CRO with a strong team of clinical and analytical researchers that have already conducted clinical trials in COVID-19 patients. BetterLife and Equilab will conduct the placebo-controlled blinded trials in COVID-19 patients at Equilab's own 75 bed clinical facility.

"We are very pleased to work with Equilab's team to conduct our studies in COVID-19 patients. We changed the site of our proposed AP-003 clinical trials in COVID-19 patients from Australia to Indonesia. There are more than 10,000 cases of COVID-19 infections reported each day in Indonesia as Australia records less than 20 per day. Our teams are hard at work to initiate these trials as soon as possible. We will communicate details of the proposed trials in the coming weeks" said Ahmad Doroudian, CEO of BetterLife.

He continued, "In the fight against Covid the best approach may well be a combination of IFN-α2b with Remdesivir and/or the monoclonal antibodies. Most treatments are expensive and not administered into the airways where the virus resides. We believe that an inhaled IFN-α2b, such as the Company's AP-003 that directly targets the airways, will have widespread utility as a treatment and preventative measure against COVID-19 and other such viral infections. While millions of people around the world may well have access to a vaccine, eventually, there will be hundreds of thousands for whom the vaccine may well not work and will require effective treatment options such as AP-003."   For more information about BetterLife Pharma please visit:  https://abetterlifepharma.com/ 

Other recent developments in markets include:

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, is establishing its first Centre of Excellence in collaboration with The Sheppard Pratt Institute for Advanced Diagnostics and Therapeutics in Baltimore, Maryland, United States.

The Centre of Excellence will model the "clinic of the future", showcasing the best thinking in science, therapy, technology, and design. Working as a research facility and innovation lab, it will generate evidence to shape therapy models in mental health care, train and certify therapists, conduct clinical trials including proof-of-concept studies, and prototype digital solutions to improve patient experience. The first wave of research will focus on COMPASS's investigational COMP360 psilocybin therapy, which comprises administration of COMP360 psilocybin with psychological support from specially trained therapists.

MindMed (NEO: MMED) (OTCQB: MMEDF), a leading psychedelic medicine biotech company, recently announced the start of the first ever clinical trial measuring and evaluating MDMA and LSD used in combination in the human body. The trial will be conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland.

If administered in combination with LSD, MDMA may increase positive subjective drug effects, including positive mood and empathy, and reduce the negative emotions and anxiety that are sometimes associated with LSD - producing an overall more positive experience.

CytoDyn Inc. (OTCQB: CYDY), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, recently announced a research manuscript submitted by Nicholas J. Agresti, M.D. has been accepted for publication in the Journal of Translational Autoimmunity. Dr. Agresti's research findings were based on four critically ill COVID-19 patients treated with leronlimab under eIND.

The manuscript Ms. No. JTAUTO-D-20-00043R1 is entitled "Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case Series of Four Critically Ill Patients Treated with Leronlimab."   Nicholas J. Agresti, M.D., stated, "We are very thankful with the clinical outcomes for these patients and are honored by the acceptance of our research for publication. We hope this work will continue to advance research to understand how to effectively mitigate the effects of COVID-19."

Synairgen plc (OTCPK: SYGGF), the respiratory drug discovery and development company, recently announced that recruitment of 120 COVID-19 patients into its Phase II trial evaluating inhaled formulation of interferon-beta-1a (SNG001) conducted in the home setting has now been completed. Results from the trial are expected in Q2 2021.

Synairgen's two-part, placebo-controlled trial evaluating SNG001 as a treatment for COVID-19 infection involved dosing of (i) 101 patients in the hospital setting, the positive results from which were published in The Lancet Respiratory Medicine in November 2020¹, and (ii) 120 'at risk' patients in the home setting, recruitment for which completed yesterday.

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