Biotechs with Key Corporate Developments

Oct 03, 2016, 09:00 ET from FinancialBuzz.com

NEW YORK, October 3, 2016 /PRNewswire/ --

Performing clinical trials is an essential research tool for progressing medical awareness and patient care. Clinical research is complete only if doctors aren't sure whether a brand new method works well on individuals and is harmless and which treatments or approaches work best for valid infections or groups of people. If clinical trials are to be successful, it is crucial that more people participate. Citius Pharmaceuticals Inc. (OTCQB: CTXR), Tobira Therapeutics Inc. (NASDAQ: TBRA), Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR), Dicerna Pharmaceuticals Inc. (NASDAQ: DRNA), Catabasis Pharmaceuticals Inc. (NASDAQ: CATB).

Citius Pharmaceuticals Inc. (OTCQB: CTXR) announced recently that it has begun the essential Phase 3 clinical trial of their product, Mino-Lok™. Mino-Lok is an alternative to eliminating and substituting central venous catheters (CVCs). Of nearly 7 million CVCs handled annually, around 7% become tainted leading to life threatening infections known as catheter-related blood stream infections (CRBSIs). Combining Mino-Lok with suitable universal antibiotics, is used to retain central venous access and dodge the difficulties connected with catheter abstraction and replacement.

Citius Pharmaceuticals Inc. (CTXR) Phase 3 trial is a multi-center, randomized, double-blind study of approximately 700 patients to discover the effectiveness and wellbeing of Mino-Lok Therapy, a novel antibiotic lock therapy that syndicates minocycline with edetate disodium in 25% ethanol solution. The key endpoint is the amount of substantial percentage of subjects gaining total success in upholding the treated CVCs at the test of treatment at week 8. Secondary endpoints is the wellbeing and acceptability as defined by opposing events, serious adverse events (SAEs), critical indications, clinical laboratory calculations, and physical analyses. Phase 3 clinical trial is likely to take 2 years to complete. The first patient is anticipated to be registered in early 2017.  Medpace has been selected as the trial administration clinical research organization. President and Chief Executive Officer, Mr. Myron Holubiak commented, "This is a major milestone for Citius as our lead product is entering registration trials. Mino-Lok has the potential to become a standard of care (SOC) for treating CRBSIs."

Another biopharmaceutical company that also focuses on research and development of therapies, Tobira Therapeutics Inc. (NASDAQ: TBRA) has initiated Phase 1 research against non-alcoholic steatohepatitis (NASH) and other liver related diseases by combining the company's product candidate, cenicriviroc with evogliptin. Tobira believes that patients with NASH will benefit the most from its therapies, tackling several mechanisms. The statistics produced in its CENTAUR Phase 2b research confirmed that cenicriviroc has strong and tolerable anti-fibrotic activity. The anti-fibrotic mechanism of cenicriviroc delivers a concrete support to which metabolically-targeted agents such as evogliptin can be added, thus combining cenicriviroc and evogliptin could be effective to address several drivers of NASH.

Clinical-stage RNA interference therapeutics company, Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) publicized collaboration with biopharmaceutical giant, Amgen to develop and possibly commercialize two of Arrowhead's experimental cardiovascular therapies. Amgen settled to a global license for Arrowhead's RNAi ARC-LPA database intended as a novel treatment for elevated lipoprotein (a), a danger factor for atherosclerotic cardiovascular disease. In a separate deal, Amgen will too obtain an opportunity for a global license to an RNAi therapy indicated for undisclosed cardiovascular target. Amgen will be accountable for the clinical development and commercialization of both experimental therapies.

Dicerna Pharmaceuticals Inc. (NASDAQ: DRNA) had announced that the Company will center its main focus on its proprietary GalXCTM technology platform to advance progress of product candidates in its core therapeutic areas of rare diseases, chronic liver diseases, cardiovascular disease and viral infectious diseases. Under this plan, Dicerna will transition its primary hyperoxaluria (PH) development program to focus on DCR-PHXC, a subcutaneously delivered GalXC clinical candidate, which was announced earlier this year.

Catabasis Pharmaceuticals Inc. (NASDAQ: CATB) and Sarepta Therapeutics, Inc. a commercial-stage developer of innovative RNA-targeted therapeutics, has collaborated to explore a combination drug treatment approach for Duchenne muscular dystrophy (DMD). The two companies will contribute their respective expertise to study an exon skipping treatment developed by Sarepta, together with an oral NF-kB inhibition treatment developed by Catabasis in a mouse model of DMD.

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