Evelo Biosciences Inc. unveiled findings from first three cohorts of the phase II trial with EDP-1815 in atopic dermatitis, where the compound fell short of the primary endpoint: proportion of patients who achieve an outcome of at least a 50% improvement from baseline in Eczema Area and Severity Index score compared to placebo at week 16. The Cambridge, Mass.-based firm cited an unusually high placebo response rate. Focused on orally delivered microbial candidates that target the small intestinal axis to drive systemic effects, Evelo said it’s reducing its workforce due to a “challenging financial macro-environment,” although details were not disclosed. Evelo will continue to pursue approval of EDP-1815 in psoriasis. Shares of the company (NASDAQ:EVLO) were trading midday at 81 cents, down 23 cents, or 22%.

Future of US biosimilar pipeline could rest on Humira competition

A lot of biosimilar sponsors and wannabes will be watching as the Humira biosimilar competition unfolds in the U.S. While the competition started yesterday with the launch of Amgen Inc.’s Amjevita, the true test of the strength of the competition likely will come in several months when other adalimumab biosimilars, including an interchangeable, hit the market. The developing Humira competition is a “monumental pharmaceutical event,” Stephen Pagnotta, the biosimilar commercial brand lead at Boehringer Ingelheim GmbH, told BioWorld, as it will present a business case study for the future of the U.S. biosimilar pipeline.

Taysha ponders new study for ultra-rare disease as stock droops

Taysha Gene Therapies Inc.’s stock (NASDAQ:TSHA) was struggling at midday following the U.S. FDA’s recommendation that the company dose more patients in a double-blind, placebo-controlled study of the ultra-rare indication giant axonal neuropathy (GAN). The recommendation emerged from a type B end-of-phase II study meeting held in January. The company is developing TSHA-120, an intrathecally dosed AAV9 gene therapy for treating GAN. It is Taysha’s most advanced program. There are no approved treatments for GAN, which results in death for patients in their late teens or early twenties. In October, Astellas Pharma Inc. invested $50 million in Taysha in exchange for 15% of the company and exclusive options to in-license Taysha’s TSHA-102 for Rett syndrome and TSHA-120 for GAN. Shares were trading 28% lower at midday at about $1.16 each.

As geopolitical tensions mount, China increasingly views IP through national security lens

The ruling Communist Party of China (CPC) increasingly views intellectual property (IP) through a national security lens, and generally accepted concepts of IP as a private right and respect for the rule of law don’t always apply as China prioritizes its pursuit of global technology dominance. Over the last 15 to 20 years, the CPC has viewed IP as related to economic reform and economic development, but its stance shifted markedly in its most recent 20th-year Congress report, which placed IP and innovation policies in a section focused on strengthening China’s science and technological abilities as an extension of state power.

Sciwind Biosciences starts patient dosing in phase III clinical trial for ecnoglutide

Sciwind Biosciences Co. Ltd. started dosing in a phase III clinical trial in China of its ecnoglutide (XW-003) candidate in adults with type 2 diabetes, targeting patients who have not responded adequately to either metformin or changes in lifestyle. Ecnoglutide is an injectable glucagon-like peptide-1 analog and has been shown to be safe and well-tolerated. In earlier phase II trials, it showed that it can reduce glycated hemoglobin and weight.

Sirnaomics seeks FDA guidance for phase III skin cancer candidate

Sirnaomics Ltd. is gearing up to start a phase III clinical trial for its lead siRNA candidate, STP-705, for the treatment of two non-melanoma skin cancers: squamous cell carcinoma in situ and basal cell carcinoma. STP-705 comprises two siRNA oligonucleotides which inhibit transforming growth factor beta 1 and cyclooxygenase-2 gene expressions and is delivered via injection using what the company describes as a polypeptide nanoparticle-enhanced delivery mechanism.

The BioWorld Insider Podcast: Rethinking obesity – Fitness may be more directly linked to health than weight

After many years of research and development, drug-induced weight loss has matured into a viable therapeutic option. But do the drugs directly help people become healthier or is it the weight loss? There are longstanding concerns that the health effects of weight might be overrated. And new studies show fitness improves health outside of weight. So, can a person still be considered healthy despite being over a “normal” weight? How will future medical science consider what is called the obesity epidemic? In this edition of the BioWorld Insider podcast, BioWorld Science Managing Editor Anette Breindl, discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness which in many ways goes against the mainstream health care state of mind about obesity.

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