San Mateo, CA – November 19, 2015 – Afferent Pharmaceuticals, a leader in the development of small molecule compounds for the treatment of poorly managed and common neurogenic disorders, today announced the appointments of Prabha N. Ibrahim, Ph.D., as chief technology officer and Michelle Carpenter, J.D., RAC, as vice president of regulatory affairs and project management. The Company is expanding its executive team as it advances its lead program and first-in-class drug candidate, AF-219, to late-stage clinical development and potential registration. AF-219 is a selective, non-narcotic, and orally administered P2X3 antagonist that targets the mechanism by which certain nerve fibers become hyper-sensitized and can lead to chronic and debilitating symptoms.
Afferent Pharmaceuticals Expands Executive Leadership Team With Appointments of Prabha N. Ibrahim, PhD, as Chief Technology Officer and Michelle Carpenter, JD, RAC, as Vice President, Regulatory Affairs and Project Management
Afferent Pharmaceuticals Announces Phase 2 Clinical Trial with AF-219 in Cough in Idiopathic Pulmonary Fibrosis (IPF) Patients
San Mateo, CA, November 11, 2015 – Afferent Pharmaceuticals, a leader in the development of small molecule compounds for the treatment of poorly managed and common neurogenic disorders, today announced that it has initiated a Phase 2 clinical trial with AF-219 in idiopathic pulmonary fibrosis patients (IPF) with cough. AF-219 is a selective, non-narcotic and orally administered P2X3 antagonist that targets the mechanism by which certain nerve fibers become hyper-sensitized and can lead to chronic and debilitating symptoms. The study is expected to enroll at least 30 patients at more than 15 sites in the United States, including leading pulmonary fibrosis specialty treatment centers.
Thrasos Strengthens Composition of Matter Coverage on THR-184 with Japanese Patent Decision
MONTREAL, November 10, 2015 – Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, announced today that it received notice of a Decision to Grant on an important composition of matter patent from the Japanese Patent Office. This decision covers Application No. 2012-193673, entitled "Tdf-related compounds and analogs thereof." This patent provides coverage for Thrasos' lead product THR-184, currently in Phase 2 clinical testing for the prevention of acute kidney injury (AKI) in patients undergoing cardiac surgery. The Company's 452 patient Phase 2 trial has completed enrollment and data is expected in early 2016.
CoLucid Pharmaceuticals Announces Election of Mark Corrigan, M.D., to Board of Directors
CAMBRIDGE, Mass., Oct. 27, 2015 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that Mark Corrigan M.D., has been elected by the Board of Directors to serve as a director. Dr. Corrigan is filling a seat created by the resignation of Richard Markham, and will serve as a class II director of the Company with a term expiring at the annual meeting of stockholders to be held in 2017. In addition, Dr. Corrigan has been elected as Chairman of the Compensation Committee. CoLucid's Board remains at seven directors, six of whom are independent.
ENVISIA THERAPEUTICS’ LEAD PRODUCT CANDIDATE, ENV515 (travoprost XR), ACHIEVES PRIMARY EFFICACY ENDPOINT IN PHASE 2A GLAUCOMA CLINICAL TRIAL
RESEARCH TRIANGLE PARK, NC – OCTOBER 6, 2015 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported results from its first clinical trial of the Company’s lead product candidate, ENV515 (travoprost XR). In this phase 2a trial, ENV515 achieved its primary efficacy endpoint by demonstrating a statistically significant and clinically meaningful reduction in intraocular pressure (IOP) with results comparable to topical once-daily TRAVATAN Z® (travoprost ophthalmic solution).
Chimerix Presents Preliminary Data on Brincidofovir in Liver Transplant Recipients With Adenovirus Infections at IDWeek in San Diego
DURHAM, N.C., Oct. 7, 2015 – Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today preliminary data from liver transplant patients who received brincidofovir for adenovirus infection through the ongoing AdVise trial and the brincidofovir expanded access program. These data will be presented at IDWeek in San Diego.
CoLucid Pharmaceuticals Announces Initiation of Phase 3 Long-Term, Open-Label Trial of Lasmiditan in Migraine.
CAMBRIDGE, Mass., Oct. 8, 2015 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that the first patient has been randomized in the Company's GLADIATOR study, a Phase 3 long-term, open-label trial of lasmiditan.
The objective of GLADIATOR is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability. Migraine patients who complete CoLucid's ongoing first Phase 3 pivotal trial, SAMURAI, as well as the Company's second Phase 3 pivotal trial, scheduled to commence in the first half of 2016, will be eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 subjects, who will be randomized to receive 100 mg or 200 mg of lasmiditan, and treated for up to eight migraine attacks per month for one year.
Medtronic TYRX(TM) Neuro Absorbable Antibacterial Envelope now Available for Use with Implantable Neurostimulators
Dublin – October 7, 2015 – Medtronic plc today announced the first implants of the TYRX(TM) Absorbable Antibacterial Envelope with Medtronic Deep Brain Stimulation (DBS) systems. The implants were conducted by Francisco Ponce, M.D., director, Barrow Center for Neuromodulation, at the Barrow Neurological Institute in Phoenix. Medtronic recently received FDA clearance for the TYRX Neuro Absorbable Antibacterial Envelope for use with implantable neurostimulators (INS), and the product is now commercially available across the United States as an option for use with all DBS systems. In the coming months, Medtronic also plans to make the TYRX Absorbable Antibacterial Envelope available as an option for use with implantable neurostimulators to treat chronic pain and bladder and bowel control disorders.
The TYRX Absorbable Antibacterial Envelope is a mesh envelope that securely holds an INS or cardiac implantable electronic device (CIED). It is designed to stabilize the device after implantation while releasing two antimicrobial agents, minocycline and rifampin, over a minimum of seven days to help prevent surgical-site infections, which are associated with substantial morbidity, mortality and cost.
Wake Forest Baptist Medical Center Creates $15 Million Program to Develop Life Science Technologies
WINSTON-SALEM, N.C. – Oct. 7, 2015 – Wake Forest Baptist Medical Center today announced the creation of a Technology Development Program, a $15 million program to develop the ideas, discoveries and inventions of the faculty and staff of the Medical Center into life science technologies having the potential to benefit patients in the community and worldwide. The new program is in partnership with leading life science investment firm Pappas Capital, in Durham. Funds will be managed by Pappas in collaboration with Wake Forest Innovations to advance clinically important life science technologies for licensing to established companies or startups.
Anthera Announces Initiation of the SOLUTION Clinical Study of Oral Sollpura(R) (liprotamase) Unit-Matched Therapy of Non-Porcine Origin in People With Cystic Fibrosis
HAYWARD, CA, Oct. 2, 2015 – Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced the initiation of the SOLUTION (Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in People With Cystic Fibrosis) Phase 3 clinical study evaluating the efficacy and safety of Sollpura® (liprotamase), a microbial derived, biotech pancreatic enzyme replacement therapy (PERT), compared to an approved, porcine-derived, enteric-coated product for the treatment of exocrine pancreatic insufficiency (EPI).
Study to enroll approximately 130 patients with exocrine pancreatic insufficiency
More than 50 clinical sites around the United States and Europe are expected to participate
Anthera to host reception at the North American Cystic Fibrosis Conference to discuss the SOLUTION program.
