-=Adamis Pharma (ADMP) : Fast-Track Application for Covid Drug

 

10:54 AM ET 1/10/22 | Dow Jones

Adamis Pharmaceuticals Corp. shares rose more than 30% on Monday after the biopharmaceutical company said it had filed for U.S. Food and Drug Administration fast-track designation for Tempol for the treatment and prevention of Covid-19.

The San Diego company, which is currently conducting a Phase 2/3 study of Tempol in adults with confirmed Covid-19 infection, said the drug has been shown to have antiviral, anti-inflammatory and antioxidant activity.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Adamis said that while the FDA has recently approved oral antiviral Covid-19 drugs, including pills from Pfizer Inc. and the team of Merck & Co. and Ridgeback Biotherapeutics, the company believes Tempol would qualify for the designation because of its unique mechanism of action and safety profile.

Adagio Therapeutics (ADGI) : antibody will protect against omicron

• Co today provided information related to the potential of its lead SARS-CoV-2 antibody, ADG20, an investigational monoclonal antibody product candidate designed to provide broad neutralizing activity against SARS-CoV-2, to address the Omicron variant; co expects that ADG20 will retain activity against Omicron. Co is conducting in vitro studies to determine the neutralization activity of ADG20 against Omicron, and initial data is anticipated by the end of the year.

 

-=Merck (MRK) : experimental COVID-19 pill reduces the risk of hospitalization, death by half

• WASHINGTON (AP) — Drugmaker Merck said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the U.S. and around the world to authorize its use.
• If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major step forward in global efforts to control the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.

Merck and Ridgeback's investigational oral antiviral molnupiravir reduced the risk of hospitalization or death by approximately 50 percent compared to placebo for patients with mild or moderate COVID-19 in positive interim analysis of phase 3 study

• Co announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377).
• Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.
• Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results.

-=Adamis Pharma (ADMP) submits a Covid drug to FDA

• Adamis is requesting the FDA's permission for investigational use of its Covid treatment drug Tempol. 

Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients. Numerous published articles describing animal models of ARDS show Tempol to cause a decrease in lung inflammation and preserve lung pathology associated with acute and chronic lung injury. To this end, Tempol has been shown to decrease the genes (HIF-la and HIF-2a) associated with hypoxia. Hypoxia is a key indicator often associated with severe disease and a poor outcome. Controlling hypoxia and the cytokine storm can be considered essential to the successful treatment of COVID-19.

Dr. Dennis J. Carlo, President and CEO of Adamis commented: “With over 23 million COVID-19 infections in the US and over 394,000 deaths in the US (according to the CDC), additional treatments are urgently warranted. We believe that Tempol could play a pivotal role not only in the treatment of COVID-19, but actually in preventing hospitalization. With new mutations occurring in the virus, it is apparent there is an ongoing need for new therapies. 

-=Sorrento Therapeutics (SRNE) receives FDA clearance to proceed with Phase 1 clinical trial of Covid drug

• Update Feb 22, 2023: Sorrento is embroiled in a legal battle with NantCell. After losing in court in December 2022, Sorrento filed for Chapter 11 bankruptcy. 

 Sorrento Therapeutics receives FDA clearance to proceed with Phase 1 clinical trial of STI-1499 (COVI-GUARD) neutralizing antibody in COVID-19 positive patients

Co announced that it received a study may proceed letter from the FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized COVID-19 patients.

As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies.

STI-1499 was further evaluated in preclinical studies using multiple strains of SARS-CoV-2, including the highly contagious D614G variant. In these preclinical studies, the antibody has been 100% effective against the highly contagious D614G variant strain at similar doses to those observed in experiments with the USA-WA1/2020 strain.

Animal data generated in Syrian Golden hamsters infected with SARS-CoV-2 was presented to the FDA in support of a post-exposure human treatment dose for the IND. The effective dose in the hamster model translates to a projected total dose of approximately 160mg for a human patient.

The highest proposed dose (200 mg per patient) in the phase 1 trial is a lower dose than currently being tested for other known SARS-CoV-2 targeted antibodies or antibody cocktails in active clinical studies. The potentially high potency of STI-1499 antibody may allow for rapid scaling up of manufacturing operations.

The STI-1499 clinical program is being designed for rapid adaptive expansion, including international sites in Brazil to supplement the US program.