Your Daily Pharma Scoop: Tonix Progresses, J&J Succeeds, Quidel Is Cleared

Stocks in News: TNXP, JNJ

Tonix Pharmaceuticals receives fast track designation for TNX-102 SL for treatment of agitation in alzheimer’s disease

Discussion: Tonix Pharmaceuticals’ (TNXP) TNX-102 sub-lingual (‘SL) for treatment of agitation in Alzheimer’s disease receives FDA Fast Track designation. The candidate is in a Phase 3 trial for military-related posttraumatic stress disorder (‘PTSD). An interim data analysis is expected in Q3. The new status will allow frequent interaction with the FDA review team and a rolling review of the marketing application. On this positive news the shares are up 23%.

Earlier, Tonya (TNX-102) cleared its IND application to support the initiation of a pivotal Phase 2 efficacy study and received Breakthrough Therapy designation in Phase 3 development for the treatment of PTSD. In 2015 the company conducted its Phase 3 clinical trial of TNX-102 SL in fibromyalgia. The study planned to enroll approximately 500 patients with fibromyalgia at approximately 35 clinical centers in the U.S.

As a serious condition leading to chronic disability and overall high healthcare costs, PTSD creates a heavy burden on individual families as well collectively on the community. In the U.S., National Comorbidity Survey Replication (‘NCS-R), February 2001 – April 2003, using using DSM-IV criteria among the nationally representative sample of 9,282 Americans aged 18 years and older, PTSD was assessed among 5,692 participants. According to the NCS-R estimate the lifetime prevalence of PTSD among adult Americans is 6.8%. previous year PTSD prevalence was estimated at 3.5%.

Apart from TNX-102, the company is developing TNX-601 and TNX-801. TNX-601 is in its pre-IND stage of development. The candidate is an oral formulation of tianeptine and is being developed also for the treatment for PTSD. At present there is no FDA-approved tianeptine-containing product. However, the compound is marketed for the treatment of depression since 1987 in Europe, Asia, and Latin America. Even if the compound has structural similarities with classic tricyclic antidepressants, but the company claims that it has unique pharmacological and neurochemical properties.

The other candidate TNX-801 is live virus vaccine grown in cell culture. TNX-801 is being developed as a potential smallpox preventing vaccine for future outbreak as well as for national stockpile in case of a future scenario of bioterror. Though it shares structural characteristics with vaccinia-based vaccines, the company again claims that the candidate’s lower toxicity and potential safety advantages are definite advancement over existing vaccinia-based vaccines.

J&J stops late-stage study of Invokana in type 2 diabetics with CKD after endpoints met

Discussion: Johnson & Johnson (JNJ) unit Janssen Pharmaceutical announced the early termination of its Phase 3 clinical trial of its Invokana (canagliflozin) for renal and cardiovascular outcomes in participants with diabetic nephropathy. Independent Data Monitoring Committee recommended that the ongoing study be stopped. The committee based on their recommendation on the basis of their conclusion that the study had met the efficacy endpoints.

A worldwide public health concern, Type 2 diabetes mellitus (‘DM), is a major cause of morbidity and mortality. Microvascular and macrovascular complications often arise out of Type 2 DM. Among the most serious long-term microvascular complications of DM, is diabetic nephropathy (‘DN). DN is characterized by proteinuria. Along with the rising number of DM, the proportion of DN is increasing worldwide.

DN is the leading cause of chronic kidney diseases and end-stage renal disease, which constitutes the major workload of dialysis centers worldwide. The prevalence of diabetes worldwide has reached epidemic magnitudes and is apprehended to affect more than 350M people by the year 2035. In the Western world, diabetic kidney disease is the primary single cause of end-stage kidney disease (‘ESKD).

In other News

FDA clears Quidel molecular test for whooping cough

Quidel’s (QDEL) Solana Bordetella Complete Assay, a qualitative molecular diagnostic test for pertussis (whooping cough) and parapertussis receive FDA clearance.

OPKO’s Rayaldee OK’d in Canada

Health Canada approved OPKO Health’s (NYSEMKT:OPK) Rayaldee (calcifediol extended-release capsules) for the treatment of secondary hyperparathyroidism in adults with stage 3 or stage 4 chronic kidney disease and vitamin D deficiency.

Gene editing stocks under pressure on paper detailing unwanted DNA changes

Stocks of the three major CRISPR/Cas9 gene-editing companies Intellia Therapeutics (NASDAQ:NTLA), Editas Medicine (NASDAQ:EDIT) and CRISPR Therapeutics (NASDAQ:CRSP) are all in the red following a just-published paper in Nature Biotechnology that claimed serious problems for the technology.

Pfizer launches late-stage study of hemophilia B gene therapy

Pfizer (NYSE:PFE) begins Phase 3 open-label lead-in study of its current factor IX prophylaxis replacement therapy in the standard care setting for patients with hemophilia B.

Cesca launches autologous bone marrow cell processing system; shares up 10% premarket

Cesca Therapeutics (NASDAQ:KOOL) announced that its subsidiary ThermoGenesis has launched its PXP System for the rapid processing of autologous bone marrow cells in a point-of-care setting.

Ironwood launches late-stage study of linaclotide in IBS-C; shares up 3% premarket

Ironwood Pharmaceuticals (NASDAQ:IRWD) announced beginning of its Phase 3b trial of its linaclotide for the treatment of multiple abdominal symptoms, including bloating and discomfort, and pain in adult patients with irritable bowel syndrome with constipation (‘IBS-C). Estimated primary completion date is July 2019.

FDA OKs Stryker flow-diverting stent

Stryker’s (NYSE:SYK) Surpass Streamline Flow Diverter for the treatment of unruptured large and giant wide neck intracranial aneurysms receives FDA approval. The stent redirects blood flow within an intracranial artery away from a weakened blood vessel sac or aneurysm.

NuVasive launches next-gen spinal fusion system

NuVasive (NASDAQ:NUVA) announced the commercial launch of its Reline MAS Midline system used in spinal fusion procedures.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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