Resverlogix Reports Filing of New Intellectual Property on Key Renal Protection and Glucose Control Markers

Significantly Strengthens Intellectual Property Portfolio and Apabetalone’s Commercial Runway Position Through 2040

BETonMACE Results Show Significant Improvement of Key Markers of Diabetes and Renal Function in the Combination of Apabetalone and SGLT2 inhibitors

CALGARY, Alberta, Nov. 02, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX: RVX) is pleased to announce today highly significant findings on synergy on improved renal function, as measured by estimated glomerular filtration rate (eGFR), and glucose control, as measured by glycated hemoglobin (HbA1c), when apabetalone is combined with sodium-glucose cotransporter-2 (SGLT2) inhibitors, a leading oral anti-diabetic therapy class. These unexpected findings in the BETonMACE Phase 3 trial resulted in the filing of two additional provisional patent applications, further strengthening Resverlogix’s intellectual property portfolio.

The combination of apabetalone and the SGLT2 inhibitors, in addition to standard of care medicines, resulted in a significant improvement of key renal function marker eGFR compared to SGLT2 inhibitors and placebo (p=0.05). Additionally, a significant reduction of plasma Hb1Ac was also observed in patients receiving the combination of apabetalone and the SGLT2 inhibitors, on top of standard of care treatment, compared to placebo (p<0.001). Details of these findings are planned to be submitted to a leading peer review journal in the near future.

“The robust safety and efficacy demonstrated by the combination of apabetalone and SGLT2 inhibitors greatly assists us in our strategic partnership discussions and significantly enhances our intellectual property portfolio and commercial runway position through 2040,” stated Donald McCaffrey, President and CEO. “These important findings – coupled with the significant MACE reduction effects previously highlighted for this patient group – positions the combination of apabetalone and SGLT2 inhibition as a truly novel approach in the treatment for millions of high-risk diabetes and CKD patients worldwide.”

“Plasma eGFR and Hb1Ac are critical markers used to evaluate renal function and glucose control in high-risk patients with kidney disease and diabetes,” stated Kenneth Lebioda, Senior Vice President of Business & Corporate Development. “Control of these markers play a key role in CVD risk reduction as observed in the BETonMACE study, including heart attack, heart failure and CVD death in these patients. These novel and unexpected findings are now patent protected and allow for Resverlogix to explore additional important indications for the combination of apabetalone and SGLT2 inhibitors with an accelerated path to commercialization.”

About eGFR and CKD

According to the National Kidney Foundation, renal function, as measured by eGFR is the strongest non-invasive way to assess renal function and the stage of chronic kidney disease (CKD) in patients. Using a patient’s blood creatinine level, age, body size and gender, physicians can determine the stage of CKD and the optimal treatment plan to improve the likelihood of reducing kidney disease and associated-disorders progression. In the Global Burden of Disease Study, CKD is estimated to affect nearly 700 million people worldwide, many of them still undiagnosed. CKD and worsening renal function impact several other high-risk patient disease groups, and serves as a comorbidity for diabetes, while also indirectly

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Pfizer says earliest U.S. filing for COVID-19 vaccine would be late November

(Reuters) – Pfizer Inc PFE.N said on Friday it could file in late November for U.S. authorization of the COVID-19 vaccine it is developing, suggesting that a vaccine could potentially be available in the United States by the end of the year.

That timeline makes it unlikely, however, that a vaccine will be available before the U.S. election, as President Donald Trump has promised. Pfizer, which is developing the vaccine with German partner BioNTech 22UAy.F, said that it may confirm if the vaccine is effective as soon as this month but that it also needs safety data from a 44,000-person clinical trial that will not be available until next month.

The Pfizer news, published in a letter from its chief executive on its website, lifted the U.S. stock market and the company’s shares. Shares fell slightly of rival vaccine maker Moderna Inc MRNA.O, which is close to Pfizer in its vaccine development.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said, noting that he published the letter to provide greater clarity on the timeline for the vaccine.

People around the world are counting on a vaccine to control the spread of the coronavirus, which has killed more than a million people and ravaged the global economy.

Fears of delays were raised after trials for two rival vaccines were put on hold in the United States in recent weeks.

Trump has said repeatedly that there would be a vaccine available before the Nov. 3 election.

When asked about the Pfizer news, White House spokesman Judd Deere said, “The president continues to be optimistic that we will have one or more vaccines very soon, before the end of the year.”

The U.S. government’s Operation Warp Speed program has spent billions of dollars on development of vaccines and treatments. It has signed a deal to buy Pfizer vaccine shots if they work.

But the rush to develop a vaccine has raised concerns that the U.S. Food and Drug Administration, acting in haste, might not conduct an adequate review.

U.S. health officials have sought to assuage those concerns. Earlier this month, the FDA formalized a requirement that the vaccine-makers collect two months of safety data on one-half of trial participants.

Pfizer has been trying to demonstrate that its decision-making is being driven by science rather than politics, Mizuho analyst Vamil Divan said.

“Just getting it to the market is only a small part of it,” Divan said. “People should actually be willing to take it.”

FILE PHOTO: The logo of U.S. pharmaceutical corporation Pfizer Inc. is seen at a branch in Zurich, Switzerland October 2, 2018. REUTERS/Arnd Wiegmann

Rival vaccine-maker Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as

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