Inflammation

Menstrual health literacy is alarmingly low – what you don’t know can harm you

Retrieved on: 
Wednesday, March 13, 2024

When I ask my menstrual health workshop participants – including clinicians – there’s usually a lot of shrugging and shaking of heads.

Key Points: 
  • When I ask my menstrual health workshop participants – including clinicians – there’s usually a lot of shrugging and shaking of heads.
  • If given multiple choice options, most think that periods either “clean the womb” or somehow “help prepare for pregnancy”.
  • Yes, the blood part can stain clothing, but there is nothing pathological, contaminating, or dangerous about periods.

So, why do we have periods?

  • Periods likely evolved as a kind of preemptive abortion, to protect women from unviable or dangerous pregnancies.
  • As a result, we have low rates of conception, high rates of miscarriage, and extremely high rates of maternal mortality in comparison to other mammals.
  • The menstrual cycle is critical for facilitation of the initial steps of this raison d’être of the female reproductive system.
  • The menstrual cycle is critical for facilitation of the initial steps of this raison d’être of the female reproductive system.

What else don’t we know?

  • Perhaps with the fact that the second phase of the cycle from ovulation to menstruation is a series of highly inflammatory processes.
  • This was only very briefly mentioned in three out of 16 textbooks.
  • We really ought to be taught from puberty how to reduce period pain and blood loss – this is not difficult science.

Why aren’t we taught this stuff?

  • My research shows that the exclusive focus on the female sex hormones in menstrual education is informed by societal influences, such as the myth of the hysterical or hormonal female.
  • This gender myth is still alive and well, although now we tend to blame the (female sex) hormones.
  • Again, there was no scientific reason for this change in focus, although it reflected existing societal beliefs about the inherently irrational behaviour of women.
  • Unfortunately, menstrual health literacy has not yet recovered from this shift in physiological models.

So what?

  • It also becomes much easier to differentiate premenstrual changes from underlying health conditions, since the latter will not be substantially alleviated by anti-inflammatory interventions alone.
  • Teaching the reductive hormonal model of the menstrual cycle unintentionally provides pseudo-scientific evidence for the damaging hormonal or hysterical female gender myth.


Sally King is the founder of Menstrual Matters- the world's first evidence-based info hub on menstrual health and rights www.menstrual-matters.com. Her doctoral research and current research fellowship were funded by the ESRC (Economic and Social Research Council).

Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx(TM) for Recurrent Pericarditis

Retrieved on: 
Wednesday, February 21, 2024

Topline Results Expected in Q2 2024

Key Points: 
  • "Having achieved full patient enrollment, we are now positioned to announce high-level MAvERIC-Pilot clinical trial data in the second quarter of this year.
  • MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention.

VENTYX BIOSCIENCES, INC. SHAREHOLDER ALERT: Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against Ventyx Biosciences, Inc. (NASDAQ: VTYX)

Retrieved on: 
Monday, March 11, 2024

If you purchased or acquired Ventyx securities, including pursuant to the IPO, and/or would like to discuss your legal rights and options please visit Ventyx Biosciences, Inc.

Key Points: 
  • If you purchased or acquired Ventyx securities, including pursuant to the IPO, and/or would like to discuss your legal rights and options please visit Ventyx Biosciences, Inc.
  • Shareholder Class Action Lawsuit or contact Investor Relations Manager Peter Allocco at (212) 951-2030 or [email protected] .
  • Shareholder Class Action Lawsuit or contact Investor Relations Manager Peter Allocco at (212) 951-2030 or [email protected] .
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

Anaptys Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024

“We will have a number of important events in 2024 including the top-line data readout of ANB032's Phase 2b trial in atopic dermatitis by year end,” adds Faga. “We also plan to move our third and fourth ICMs -- ANB033, our anti-CD122 antagonist, and ANB101 -- into the clinic this year, with IND filings planned for Q2 and H2, respectively.”

Key Points: 
  • “Enrollment is ongoing in three global Phase 2 trials for ANB032, our BTLA agonist, in atopic dermatitis and rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ulcerative colitis.
  • The decrease relates primarily to cash used for operating activities and the $50 million stock repurchase program.
  • The change is due primarily to increased royalties recognized for sales of Jemperli offset by one development milestone achieved for cobolimab in 2022.
  • Acquired in-process research and development of $7.3 million for the three and twelve months ended December 31, 2023 related to the exclusive licensing agreement with Centessa Pharmaceuticals.

ASLAN Pharmaceuticals Provides TREK-DX Study Update and Highlights Potential of Eblasakimab in Dupilumab-Experienced Atopic Dermatitis Patients

Retrieved on: 
Monday, March 11, 2024

In conjunction with this, independent reviewer confirmation of baseline EASI scores has also been implemented.

Key Points: 
  • In conjunction with this, independent reviewer confirmation of baseline EASI scores has also been implemented.
  • Of the 9 patients who previously had an inadequate response to dupilumab, 5 patients (56%) achieved EASI-90 and 5 patients (56%) a vIGA score of 0 or 1.
  • Additional data from head-to-head studies between eblasakimab and dupilumab in skin biopsies from AD patients confirmed the differentiated effects of targeting IL-13R versus IL-4R5.
  • In this study, eblasakimab reduced localized secretion of pro-inflammatory Type 2 cytokines by the skin tissue more efficiently than dupilumab, suggesting eblasakimab could have the potential to be effective in AD patients that do not achieve an adequate response to dupilumab.

Monte Rosa Therapeutics Announces Initiation of IND Enabling Studies for MRT-8102, A First-in-Class NEK7 Directed Molecular Glue Degrader and NLRP3/IL-1β Pathway Inhibitor

Retrieved on: 
Monday, March 11, 2024

BOSTON, March 11, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced a novel development candidate, MRT-8102, a potent, highly selective and orally bioavailable NIMA related kinase 7 (NEK7)-directed MGD. MRT-8102 is expected to be developed for the treatment of inflammatory diseases driven by interleukin-1β (IL-1β) and the NLRP3 inflammasome, which are critical elements of the inflammatory process. This is the first development candidate to be declared from the Company’s NEK7 development program.

Key Points: 
  • This is the first development candidate to be declared from the Company’s NEK7 development program.
  • “In preclinical non-human primate studies, MRT-8102 has demonstrated potent and selective degradation of NEK7, reducing downstream IL-1β.
  • We believe MRT-8102 has the potential to be developed in multiple inflammatory diseases, including gout, pericarditis and other cardiovascular diseases.
  • IND-enabling studies are underway, and we plan to file our first IND for the program in the first quarter of 2025.

Ventyx Biosciences Reports Clinical Data for its NLRP3 Inhibitor Portfolio and Provides Pipeline Updates at Virtual Investor Event

Retrieved on: 
Monday, March 11, 2024

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, will provide clinical and pipeline updates today during its virtual investor event.

Key Points: 
  • We believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases.
  • We believe these data establish compelling clinical proof of concept for our peripheral NLRP3 inhibitor VTX2735.
  • At our virtual investor event, we will present data from the ongoing Phase 2 open-label extension.
  • Ventyx will host a virtual investor event today, Monday, March 11, 2024 from 11:00AM to 12:30PM ET.

Nurix Therapeutics Announces U.S. FDA Lifts Partial Clinical Hold on NX-2127 Phase 1 Trial

Retrieved on: 
Monday, March 11, 2024

SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the U.S.

Key Points: 
  • SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the U.S.
  • Phase 1a/1b study evaluating NX-2127 in adults with relapsed/refractory B-cell malignancies.
  • The partial clinical hold on the study was announced by Nurix on November 1, 2023, following the company’s communication to the FDA of its intention to transition to an improved manufacturing process.
  • “We are pleased with the timely resolution of the partial clinical hold, which allows us to reinitiate enrollment in the NX-2127 Phase 1 study utilizing drug product from our new manufacturing process,” said Paula G. O’Connor, M.D., executive vice president and head of clinical development at Nurix.

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)

Retrieved on: 
Sunday, March 10, 2024

“We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu.

Key Points: 
  • “We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu.
  • “We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”
    Every year in the United States over 100,000 patients progress to end-stage HFrEF.
  • In contrast, in ischemic patients treated with rexlemestrocel-L, IL-6 levels returned to normal by 2 months and remained low through 12 months.
  • Mesoblast intends to request a pre-BLA meeting with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in end-stage ischemic HFrEF patients with LVAD implantation.