DBV Technologies Reports Positive Extension Study Results

DBV Technologies (NASDAQ:DBVT) reported positive results from its open label extension of the Phase 3 study. The data showed that the participants underwent sustained clinical benefit with an extra two years of treatment with Viaskin Peanut. The Phase III PEPITES study aimed to assess the implications of Viaskin Peanut in children with peanut allergy.

The three years long extension study PEOPLE showed than Viaskin Peanut or DBV712 was linked to sustained response over a three-year treatment period. 75.9 percent of the patients reported improvement in eliciting dose (ED) from baseline to Month 36. 51.8 percent of the patients attained ED of minimum 1,000 mg at Month 36. The mean cumulative reactive dose was reported at 1,768.8 mg with a median of 944 mg compared to baseline reading of 223.8 mg with a median of 144 mg.

The data from the extension study also demonstrated that the drug candidate was able to show its potential across the spectrum of baseline sensitivity. It was also able to have an impact on even the most sensitive patients. Pharis Mohideen, M.D., Chief Medical Officer of DBV Technologies said,

“We are pleased that JACI has published the PEOPLE trial results, ensuring that healthcare providers will have access to these important data supporting an epicutaneous immunotherapy approach to treating one of the most common food allergies in children.”

The PEOPLE study involved patients who completed the 12-month study period of PEPITES. Participants who were randomized to receive active treatment in PEPITES were qualified to be administered up to four additional years of treatment, while the patients who were in the placebo cohort are eligible for up to five years of treatment. The analysis of the data also measured safety parameters and immune biomarkers, including immunoglobulin G4 and immunoglobulin E as well as sustained unresponsiveness following a two-month period without treatment.

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The study assessed the dosage after 36 months of active treatment. A double-blind, placebo-controlled food challenge was employed for this purpose. Each challenge was started with the initial dosage of 1 mg of peanut protein and was increased up to 2,000 mg of peanut protein. The challenges planned for after four and five years of treatment, the initial dosage was 10 mg of peanut protein and the highest dosage was 3,000 mg of peanut protein.

The data demonstrated that patients who enrolled in the trial with an ED of less than or equal to 10 mg reported a 22.5-fold rise in geometric mean ED over the course of the treatment period. The data was also in line with the elevated rate of sustained unresponsiveness recounted in a prior clinical study 1. Exploratory analyses carried out in a subset of contributors revealed that 77.8 percent were capable of maintaining desensitization for a two-month period while off therapy and without peanut consumption.

In PEOPLE trial, DBV712 showed a favorable tolerability profile, in line with the data obtained from the clinical program till date. The most commonly reported treatment-emergent adverse events included application site reactions. One patient reported a mild anaphylaxis, which resolved without treatment and the patient continued with the study. Both PEPITES and PEOPLE reported high treatment compliance with the mean of 98 percent.

Viaskin® is an investigational proprietary technology platform and has strong potential in immunotherapy. It is based on epicutaneous immunotherapy, or EPIT™, the company’s mode of delivering biologically active compounds to the immune system through intact skin.

Amneal Receives FDA Nod for Generic Fluphenazine Hydrochloride

Amneal Pharmaceuticals (AMRX) reported that the FDA has approved its generic version of Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg. The approved drug was earlier being marketed under the brand name of Prolixin by Bristol-Myers Squibb (NYSE:BMY) for treatment of schizophrenia.

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Amneal has started the commercialization process for the drug at all the dosage levels. As per the estimates provided by IQVIA™, a prominent healthcare data and analytics contributor, the annual US market for the drug was nearly $143 million for 12 months as on the end of May 2020.

Amneal is a fully integrated pharmaceutical company. It is mainly focused on developing, manufacturing and distributing generic and specialty drug products. The company has a robust portfolio consisting of nearly 250 product lines. It is boosting its portfolio by including complex dosage forms and biosimilars for treating a wide range of ailments. The company also has 65 percent stake in AvKARE, a medical and surgical supplier, mainly dealing with government agencies.

Tonix Pharma Advances Late Stage Trial of Fibromyalgia Treatment

Tonix Pharmaceuticals (TNXP) provided an update for its Phase clinical trial RELIEF. The company expects the topline data from the study to be available in the fourth quarter, while the preliminary data from the first 50 percent of randomized participants will likely be available in September this year.

The trial aims to evaluate the company’s lead drug candidate TNX-102 SL 5.6mg for treating Fibromyalgia, a chronic pain condition. It is a double-blind, placebo-controlled, randomized study. Seth Lederman, M.D., Chief Executive Officer of Tonix said,

“The completion of enrollment in our Phase 3 RELIEF trial is a significant accomplishment for Tonix as well as for the fibromyalgia community, and we look forward to announcing topline results, expected in the fourth quarter of this year.”

RELIEF set the target of nearly 470 patients across about 40 sites across the United States. The trial will have a run-in period of two weeks, during which the patients will start on TNX-102 SL 2.8 mg or placebo. After this period, all the participants will have their doses escalated to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks.

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The primary endpoint of the trial is the change in daily diary pain severity score from baseline to week 14. The data will be collected using the weekly averages of the daily numerical rating scale scores and will be analyzed using mixed model repeated measures with multiple imputation.

Tonix is a clinical-stage biopharmaceutical company. Its main focus is on developing small molecules and biologics for treating and preventing various ailments. The company’s portfolio mainly consists of drug candidates for central nervous system and immunology. The CNS portfolio comprises small molecules and biologics for treating pain, neurologic, psychiatric and addiction conditions, while immunology portfolio consists of vaccines for infectious diseases.

The company’s lead drug candidate TNX-1800 aims to treat COVID-19 by modulating T cell response, while its TNX-801 is a live horsepox virus vaccine for percutaneous administration for protecting against smallpox and monkeypox. Tonix expects the data from animal trial of TNX-1800 to be available in the fourth quarter of this year. Apart from these product candidates, the company also has TNX-1300, TNX-601 CR and TNX-1900 in the development pipeline for different indications.

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