Endometriosis has been woefully under-recognized in the medical community, and consequently, the delay between onset and diagnosis is often quite long, with some women waiting up to 12 years for a diagnosis. Research indicates that endometriosis is more common than breast cancer, prostate cancer, and diabetes, and it can affect all “women and girls, transgender, nonbinary, and gender-diverse people assigned female at birth, regardless of age, background or lifestyle, from pre-pubescence to beyond menopause,” according to Australia’s National Action Plan for Endometriosis. Australia was the first country to develop a National Action Plan for Endometriosis, and it has become a blueprint for other countries.

Freya adds $11.8M for microbial immunotherapies in women’s health

Vaginal microbiome specialist Freya Bioscience ApS has added $11.8 million to its series A, bringing the total for the round to $50 million. Of the additional $11.8 million, $10.4 million comes from the Gates Foundation and is designated for the development of vaginal microbiome-based immunotherapies for treating bacterial vaginosis, a cause of preterm birth and other pregnancy complications. This work will build on research Freya has carried out to understand the role that vaginal dysbiosis plays in infertility and how it can contribute to the failure of in vitro fertilization procedures.

Protagonist, J&J’s oral IL-23 psoriasis data strong (but short)

IL-23 receptor antagonist icotrokinra hit co-primary phase III endpoints in moderate to severe plaque psoriasis, positioning the oral peptide to lead what could be a multibillion-dollar franchise for partners Protagonist Therapeutics Inc. and Johnson and Johnson. Despite several upbeat analyst notes suggesting the candidate, which is also known as JNJ-2113, and formerly as PN-235, could become a best-in-class oral therapy – one that key opinion leaders have called the “most exciting new modality” in the space – the enthusiasm was tempered by endpoint numbers that were lower than some expected and fell short of currently approved injectable treatments, such as J&J’s Tremfya (guselkumab) and Abbvie Inc.’s Skyrizi (risankizumab). Protagonist’s shares (NASDAQ:PTGX) plunged 17.5% to as low as $33.34 in early trading Nov. 19, rising back up to $37.91 by midday. J&J’s shares (NYSE:JNJ) were trading at $152.81, down $1.96.

Incyte quits Escient urticaria drug in phase II because of toxicology

Incyte Corp. will pause enrollment in the ongoing phase II study with Mas-related G protein-coupled receptor X2 (MRGPRX2) antagonist INCB-000262 in chronic spontaneous urticaria. The move was caused by in vivo preclinical toxicology findings. The data have been shared with the U.S. FDA. Formerly known as EP-262, the drug came to Incyte by way of the late May acquisition of Escient Pharmaceuticals. Included the deal, too, was EP-547, an oral MRGPRX4 antagonist for cholestatic pruritus and other conditions with severe pruritus. Signup in INCB-000262’s proof-of-concept studies is complete, and data from all clinical work will help inform its future development, Incyte said, as well as “guide the potential development of back-up molecules.” Incyte took over Escient and its assets for $750 million plus Escient’s net cash remaining at the close of the transaction. Shares of Incyte (NASDAQ:INCY) were trading at $68.10, down $8.87, or 11%.

The Liver Meeting: A mashup of MASH data

Metabolic dysfunction-associated steatohepatitis (MASH) was the subject of multiple presentations at The Liver Meeting 2024. Some companies, such as Boston Pharmaceuticals and Inventiva SA, released new data from recently completed clinical trials, while other companies, such as 89bio Inc. and Sagimet Biosciences Inc., used their presentations to look at post-hoc cohorts of studies where the top-line results were already presented. BioWorld takes a look at the state of the vast pipeline of drugs to treat MASH.

FDA hands complete response letter to Astellas’ Izervay sNDA

The U.S. FDA issued a complete response letter (CRL) Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration. According to Astellas’ disclosure on the Japan Exchange Group Nov. 19, the FDA said it could not approve its sNDA submitted for the eye injection in its present form, although the agency’s comments outlined in the CRL were “unrelated to the benefit/risk of the use of Izervay.”

China’s NMPA accepts Ascentage NDA for Bcl-2 inhibitor lisaftoclax

China’s National Medical Products Administration (NMPA) has accepted Ascentage Pharma Group Corp. Ltd.’s NDA for its in-house-developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which could be the first domestically approved Bcl-2 inhibitor in China and the second global approval. The NDA was accepted for treating patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, and the NMPA’s Center for Drug Evaluation has recommended the drug for priority review.

BioWorld Insider podcast: Modifi gets creative on the rocky road to a multibillion-dollar buyout

For a small company, Modifi Biosciences has come a long way very quickly. In the newest episode of the BioWorld Insider podcast, founder Ranjit Bindra talks about how his company went from tiny to nearly extinct at least twice until it was acquired by Merck for $30 million up front.

Also in the news

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