DENVER, Colo., July 16, 2020- Today’s biotech headlines include developments from Emmaus Life Sciences, Inc. (OTCQB:EMMA), AC Immune SA (NASDAQ:ACIU), and Nabriva Therapeutics plc (NASDAQ:NBRV).
Emmaus Life Sciences, Inc. (OTCQB:EMMA), a leader in sickle cell disease treatment, announced this morning that it engaged Partner International “to lead the out-licensing activity for Emmaus’ prescription grade L-glutamine (PGLG) oral powder for use in the treatment of diverticulosis. This is the same active pharmaceutical ingredient found in Endari(R), which is approved by the FDA and the Israeli Ministry of Health to reduce acute complications of sickle cell disease in adult and pediatric patients five years of age and older.”
“Diverticulosis is an often asymptomatic gastrointestinal (GI) condition affecting a large segment of the adult populations in the U.S. and elsewhere. It can sometimes progress to diverticulitis, a debilitating GI disease that often requires hospitalization and on occasion surgical intervention. Based upon limited clinical results suggesting that Endari(R) may be effective in slowing and reversing the progression of diverticulosis, in April 2019 Emmaus commenced a Pilot/Phase 1 study of its PGLG oral powder to evaluate the change in the number and size of colonic diverticula and assess safety in 10 to 15 patients at multiple study sites. A preliminary interim evaluation of the first patients in the study indicates consistently positive results. Although the trial is ongoing, based upon the data obtained so far, Emmaus would intend to pursue a Phase III trial under the FDA’s abbreviated 505(b)(2) regulatory pathway.”
“With no current treatment options available, this is a serious unmet medical need with significant market potential worldwide,” stated Joanne Ball-Gautschi, CEO and President of Partner International
Swiss-based AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, announced overnight “the initiation of the second highest dosing group in the Company’s Phase 1b/2a clinical trial evaluating ACI-35.030 for the treatment of Alzheimer’s disease (AD). The decision to advance to the higher dosing group follows encouraging interim safety, tolerability and immunogenicity results from the initial dosing group.”
“Immunization with anti-Tau vaccines has become an important strategy for the treatment of AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030, which is being developed in collaboration with Janssen Pharmaceuticals, Inc., is the first AD vaccine candidate designed to generate a specific antibody response against pathologic phospho-Tau (pTau) proteins in the brain. Anti-pTau antibodies generated by ACI-35.030 have the potential to reduce the spread and seeding of Tau pathology throughout the brain.”
“The fact that ACI-35.030 shows encouraging safety and immunogenicity at the lowest dose in this elderly patient population is highly meaningful and we look forward to quickly enrolling this next dosing group,” Prof. Andrea Pfeifer, CEO of AC Immune SA, said.
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced, after yesterday’s market close, that it has entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., (NYSE:MRK) “to market, sell and distribute SIVEXTRO(R) (tedizolid phosphate) in the United States and certain of its territories. SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible Gram-positive microorganisms.”
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