Several Philadelphia-area life sciences companies made significant progress this week with development of new drug candidates targeting heart disease and viral and bacterial pathogens including Covid-19. Here's a rundown:
Venatorx Pharmaceuticals, Inc.
The Malvern pharmaceutical company announced positive results from its Phase 1 clinical trial of VNRX-7145, an oral antibiotic being developed alone and as a combination therapy with the cephalosporin antibiotic ceftibuten to treat patients with infections caused by multi-drug resistant gram-negative pathogens. The new drug candidate is targeting patients who are resistant to current standard-of-care oral and intravenous antibiotics.
“There is an urgent need for oral antibiotics to combat resistant gram-negative pathogens,” said Christopher J. Burns, CEO of Venatorx. “The increasing rate of infections caused by these organisms, and the resulting need for hospitalization for intravenous therapy places a high toll on patient health and creates significant public health and economic burdens.”
The company is planning to meet with the Food and Drug Administration to finalize the protocols for late-stage clinical testing of VNRX-7145 as a combination therapy, which it expects to initiate in the second half of 2022.
XyloCor Therapeutics
The Wayne-based biopharmaceutical company initiated mid-stage clinical testing of XC001, an experimental gene therapy being developed to treat refractory angina. The study represents the Phase 2 portion of XyloCor's Phase 1/2 clinical trial in patients with the cardiovascular disease who have no further treatment options.
“In our mission to deliver safe and effective gene therapies that transform the lives of people with cardiovascular disease, we are excited to achieve this important milestone” said Al Gianchetti, CEO of XyloCor.
Results from the study are expected next year.
XyloCor is also planning during the second half of this year to submit an additional Phase 2 clinical study to the FDA to test XC001 as an adjunctive therapy to coronary artery bypass grafting. The company also intends to study the experimental gene therapy in additional cardiovascular indications, including heart failure caused by ischemic heart disease and as adjunctive therapy to percutaneous coronary intervention.
Trevena, Inc.
The Chesterbrook biopharmaceutical company said the first patient was enrolled this week in a study of TRV027, its experimental Covid-19 therapy. The study, which involves the testing of four investigational agents to combat the viral infection, is being funded by the National Institutes of Health.
“There is no one solution to end Covid-19, and we are honored to play a role in the global effort to overcome this pandemic and mitigate its long-term impact on our communities,” said Carrie Bourdow, CEO of Trevena.
Trevena's experimental therapy, TRV027, is a novel AT1 receptor designed to block the damaging pathway of the virus that leads to acute lung damage and abnormal blood clotting, while activating the cellular pathway that selectively targets reparative actions that improve lung function and promote anti-inflammatory effects.
The NIH trial is enrolling about 1,600 patients at more than 50 sites across the country. TRV027 is part of the initial trial launch. The study will evaluate the impact of each intervention in the clinical trial on recovery, supplemental oxygen use, need for mechanical ventilation, organ failure, and mortality.
