The BIO CEO & Investor Conference is now just a week away, and buzz for the event has never been greater. Tomorrow, Inside BIO is hosting its first ever twitter chat to discuss the annual buyside survey, which has been getting great responses from the investor community. Presentation spots are still sold out as well, and we’re continuing to highlight those companies slated to present. One such company is Tetraphase Pharmaceuticals, who went public this year. Read on to hear about their antibiotic drugs, and what they see in store for them in 2014 and beyond.
What is your company’s lead product or technology?
Our lead candidate is eravacycline, a novel, fully synthetic tetracycline antibiotic that has demonstrated potent activity against a broad spectrum of bacteria, including many of the multidrug-resistant (MDR) Gram-negative bacteria highlighted as urgent public health threats by the CDC. We are currently studying the safety and efficacy of eravacycline in two Phase 3 clinical trials in the indications of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). We expect data from both trials in the first half of 2015 and to file an NDA for eravacycline in the U.S. by the end of 2015.
How does your company go about differentiating itself from the competition?
As a company, Tetraphase is unique amongst its peers, as we have built a product pipeline of novel antibiotics using our internal proprietary antibiotic discovery engine. Our chemistry technology allows for the modification of the tetracycline scaffold in ways never before possible, overcoming resistance and revitalizing the tetracycline class of antibiotics, long considered one of the safest of classes. We believe Tetraphase represents a compelling investment opportunity in the Gram-negative space, given that we are the only public company where successful market entrance offers significant upside potential in valuation. In addition, eravacycline, which was discovered using our technology platform, is the only Gram-negative candidate in late-stage development that has the potential to be used as a monotherapy with convenient once- or twice-daily dosing, and that is expected to be available in both IV and oral formulations.
Your company went public last year. What are your company’s goals and priorities for 2014?
In addition to our IPO last March, we also completed a follow-on offering in November, raising total gross proceeds of approximately $130 million during 2013. With these proceeds, we are currently executing on our Phase 3 clinical program of eravacycline. In mid-2014, we expect to have data from the lead-in portion of the Phase 3 cUTI clinical trial that will identify an oral dose of eravacycline to take into the pivotal portion of the study. We also own worldwide rights to eravacycline – announcements of single or multiple partnerships for development and commercialization rights to eravacycline outside the U.S. are possible during 2014. We continue to make progress on our pipeline as well, and expect to file an IND on our second clinical candidate TP-271, an antibiotic being developed with funding from NIAID to combat serious biothreat pathogens.
Tell us something about your company that investors might not know.
Those not familiar with the antibiotic space may not know that Tetraphase is benefiting directly from new regulatory guidelines and legislative action. In response to the rise in MDR infections and increased mortality rates and also to encourage the development of new antibiotics, the FDA no longer requires two pivotal studies per indication, permitting companies to file for regulatory approval with two Phase 3 studies in distinct indications. For eravacycline, we will be seeking approval from one Phase 3 study each in cIAI and cUTI. In addition, Tetraphase is benefitting from the GAIN (Generating Antibiotics Incentives Now) Act of 2012. Through the Act, eravacycline has received QIDP (Qualified Infectious Disease Product) designation for both the cIAI and cUTI indications, making it eligible for Fast-Track status, priority review, and an additional five years of U.S. market exclusivity should it ultimately receive FDA approval.
Investors also may not know that eravacycline actually has very broad-spectrum activity – covering not only Gram-negative bacteria, but also Gram-positive and anaerobic bacteria. Although we are pursuing Gram-negative indications currently, eravacycline has some of the most potent activity amongst currently marketed antibiotics against Gram-positive bacteria, including MRSA and VRE.
Tetraphase’s President and CEO, Guy MacDonald, will be presenting on the second day of the conference, Tuesday, February 11th at 3:00pm in Basildon. You can see the full list of presenting companies here.
Company snapshots are meant to be previews of presentations given at BIO events by way of answering set questions. BIO does not substantiate or validate any claims mentioned in company snapshots or presentations.