COVID-19 News: Ocugen Secures Manufacturing, Ampio Stops Study and More
Pennsylvania-based Ocugen, Inc. tapped Jubilant HollisterStier as its manufacturing partner for Covaxin, the vaccine developed by India-based Bharat Biotech. Ocugen has partnered with Bharat to bring the Covaxin vaccine into the U.S. market. Before Ocugen can file for EUA, the company is awaiting the final results of Bharat Biotech’s Phase III trial. Earlier this year, Bharat Biotech released interim data that showed the Covaxin vaccine demonstrated a 78% efficacy against mild to moderate COVID-19 infection and 100% efficacy against severe COVID-19.
Ampio Pharmaceuticals, Inc., based in Colorado, announced it received regulatory approval to expand enrollment of its AP-019 Phase II study assessing inhaled Ampion to India. Ampion is being assessed as a treatment for patients suffering from respiratory distress due to COVID-19. Top-line results from a Phase I study showed that Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78%. The company had been assessing Ampion in Israel, but halted that effort due to the ongoing political unrest in that country.
CoCrystal Pharma, Inc., based in Bothell, Wash., announced its lead preclinical SARS-CoV-2 3CL protease inhibitor CDI-45205 provide efficacy against the original SARS-CoV-2, as well as two prominent SARS-CoV-2 variants, Alpha and the South African variant. In vitro studies showed CDI-45205 and its analogs showed excellent antiviral activity against both SARS-CoV-2 variants, surpassing the activity observed against the original strain.
Strides Pharma partnered with Ennaid Therapeutics to manufacture an oral, repurposed medication to treat mild, moderate and asymptomatic cases of COVID‐19. Ennaid previously identified a therapeutic target to treat COVID‐19 using artificial intelligence drug discovery platforms. Initial tests show antiviral activity effective against SARS CoV‐2. In in vitro studies, Ennaid said the therapeutic inhibits inhibited 90% of the virus' replication. Ennaid is ready to seek emergency authorization from the FDA in the United States as well as approval for compassionate use in India. Strides will be the exclusive manufacturing partner to Ennaid.
Miami-based Organicell Regenerative Medicine announced its Zofin study in mild to moderate COVID-19 patients mitigated mild and moderate symptoms, improved pulmonary opacities, improved inflammatory biomarkers and was safe. Thirty days after treatment with Zofin, 83% of patients had normal lung imaging. At the start of the study, 75% of subjects had bilateral opacities caused by COVID-19. Organicell will immediately submit this data to the FDA for a requested amendment to their approved IND to perform a placebo-controlled Phase II clinical trial to confirm safety and efficacy in a randomized fashion.
A Phase III trial in Canada will assess the use of PULM-001, an oral antibacterial that also has well-recognized anti-inflammatory properties, in patients in the early stages of COVID-19. PULM-001 has been used to treat infectious diseases such as malaria, lupus, HIV and many other inflammatory infections. The repurposed drug will be administered to symptomatic adults recovering at home to lessen lung inflammation. Read more here.
The GTMRx Task Force is calling on communities across the United States to organize grassroots efforts to increase vaccinations in the country. The organizations, called Vaccine Confidence Leagues, can mobilize trusted messengers from those communities to address individuals' concerns and boost vaccine confidence and uptake, the task force said. More about this effort can be found here.