Intec flunks phase 3 Parkinsons test against Merck drug

Fiercebiotech | July 22, 2019

A phase 3 trial of Intec Pharmas Parkinsons disease drug has missed its primary endpoint, sparking a steep decline in the companys stock. The candidate uses a drug delivery system designed to improve on Mercks Sinemet but was unable to beat the established product in a late-phase test. Levodopa-based drugs such as Sinemet treat the symptoms of Parkinsons, but their efficacy declines over time, leading to off episodes in which motor symptoms reappear. Intec sought to cut the time patients spend in off episodes by delivering levodopa in a technology designed to extend its release into the stomach to up to 12 hours. Israel’s Intec thought extending the release of levodopa would reduce the time patients spend in off episodes. The late-phase clinical data on the candidate, dubbed AP-CD/LD, say otherwise. After randomizing 320 patients to receive either Sinemet or the extended-release formulation for 13 weeks, Intec analyzed patient-reported data on the time spent in off episodes. The analysis showed the extended-release formulation, which uses the same active ingredients as Sinemet, was no better than Merck’s drug. The trial was 90% powered to detect a one-hour difference between the arms. The secondary endpoint data were similarly lackluster. AP-CD/LD was no better than Sinemet on two symptom scales, and it failed to improve on the on time without troubling dyskinesia achieved by the Merck drug. Faced with the wall-to-wall failure, Intec highlighted safety data and performance in a subgroup as the positives to emerge from the trial.

Spotlight

A study led by researchers at RCSI’s Department of Chemistry has the potential to help surgeons more accurately remove tumours and detect cancer in lymph nodes during surgery. The research, led by RCSI Professor of Chemistry Donal O’Shea, has been published in Chemical Science.

Spotlight

A study led by researchers at RCSI’s Department of Chemistry has the potential to help surgeons more accurately remove tumours and detect cancer in lymph nodes during surgery. The research, led by RCSI Professor of Chemistry Donal O’Shea, has been published in Chemical Science.

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CELL AND GENE THERAPY

Biotech Startup Mekonos raises oversubscribed $25 million round to overcome pharma industry's cell & gene therapy delivery hurdles

Mekonos, Inc. | November 10, 2021

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Bio-K Plus International is expanding its portfolio of probiotic products and is launching a new line of functional beverages infused with probiotics

Bio-K | October 22, 2020

Bio-K Plus International Inc. (Bio-K Plus), pioneer in the probiotic sector and leader in the biotech industry, is pleased to announce the launch of its new line of functional beverages, Essential. Focused on offering premium quality probiotics that make a real difference in people's lives around the world, the company is adding the Essential line to its existing Pro and Original lines. In keeping with this tradition of high quality, the Essential line fits perfectly into the active and modern lifestyle of today's consumer, always looking for innovative ways to stay healthy. Bio-K Plus offers a dose of probiotics in the form of fun, delightful and balanced functional beverages. This announcement is the result of more than two years of research and development carried out by Bio-K Plus' experienced team that has developed the best line of functional beverages infused with probiotic bacteria. This project was led by Martin Croteau, Chief Commercial Officer, and was driven by the need to democratize probiotics, making them more accessible for all, and broaden their use to support global health in a more holistic manner.

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TFF Pharmaceuticals and Felix Biotechnology Sign Letter of Intent for a Collaboration, Development and License Agreement

Felix Biotechnology, Inc. | November 06, 2020

TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, and Felix Biotechnology, Inc., a clinical stage, biotherapeutic-based antibiotic development company, today jointly announce that both companies have entered into a letter of intent (LOI) which reflects the parties’ non-binding agreement in principle to negotiate and enter into a Collaboration, Development and License Agreement (CDLA). Under this proposed CDLA agreement, Felix Biotechnology would obtain a worldwide license to TFF Pharmaceuticals’ Thin Film Freezing technology to develop and manufacture dry powder formulations of a novel, bacteriophage-based biotherapeutics for inhalation delivery directly to the lungs of patients. Under the terms of the proposed CDLA and in exchange for the license to the TFF technology, Felix would agree to pay TFF Pharmaceuticals an upfront payment, development milestones, commercial milestones and royalties on net sales of the Felix biotherapeutics. A definitive CDLA is subject to the mutual agreement of the parties and a number of conditions, including Felix Biotechnology’s successful completion of a Series A financing.

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