Events

On March 2, 2019, Principia Biopharma Inc., a late-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, today announced Phase 2 clinical data from the Believe-PV study for PRN1008 as part of the Late-breaking Research: Clinical Trials program at the American Academy of Dermatology (AAD) annual meeting in Washington D.C. PRN1008 is being developed for the potential treatment of pemphigus, including pemphigus vulgaris (PV) and pemphigus foliaceus (PF). Confirming interim clinical results previously reported, the Phase 2 study reached the primary efficacy measurement of control of disease activity (CDA) on low dose corticosteroids.

“The primary goal of treating patients with pemphigus is to control the disease and heal the skin, however a significant challenge is to avoid adverse events associated with the prolonged use of corticosteroids that are typically required to achieve clinical improvement,” stated Dr. Dedee Murrell, Professor and Head of the Department of Dermatology at The St. George Hospital Clinical School, University of New South Wales in Sydney, Australia and the lead principal investigator. “PRN1008 has the potential to rapidly and effectively treat patients’ disease, while significantly reducing the exposure to moderate to high corticosteroid doses.”

The open-label Phase 2 study enrolled 27 patients with newly diagnosed and relapsed, mild to severe pemphigus (including both PV and PF). Twenty-four patients were treated with oral PRN1008 and low dose corticosteroids (LDCS; <0.5mg/kg/day) for twelve weeks, with twelve weeks of follow-up. The primary endpoint was CDA (where new lesions cease to form, and existing lesions begin to heal) at Week 4. Other secondary endpoints included complete remission rates and reduction in anti-desmoglein autoantibody levels.

Read the full press release here. 

 

On February 22, 2019,  Principia Biopharma Inc., a late-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, announced that an abstract has been accepted for oral presentation at the Late-Breaking Research during the 2019 American Academy of Dermatology annual meeting in Washington, D.C.

The abstract, “Final results of the Believe-PV proof of concept study of PRN1008 in pemphigus,” will be presented as part of the Late-Breaking Research: Clinical Trials on Saturday, March 2, 2019 at 2:10pm ET in Ballroom A of the Walter E. Washington Convention Center.

About Principia Biopharma
Principia is a late-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology. Principia’s proprietary Tailored Covalency® platform enables Principia to design and develop reversible and irreversible covalent, small molecule inhibitors with potencies and selectivities that have the potential to rival those of injectable biologics yet maintain the convenience of a pill. PRN1008, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus, an orphan autoimmune disease, and in a Phase 2 clinical trial in patients with immune thrombocytopenic purpura, a rare hematological disease. PRN2246, a covalent BTK inhibitor which crosses the blood-brain barrier, has completed a Phase 1 clinical trial in healthy volunteers, and has been partnered with Sanofi for development in multiple sclerosis and, potentially, for other diseases of the central nervous system. PRN1371, a covalent inhibitor of Fibroblast Growth Factor Receptor (FGFR) is being evaluated in a Phase 1 trial in patients with bladder cancer. For more information, please visit www.principiabio.com.

Read the full press release here.

Living with a bullous skin disease is a challenge in more ways than one.  In addition to taking medication we also need to be taking supplements, avoid certain foods and spices, take caution in how we move and bathe, and relax to reduce stress.

We also need to take extra precautions against the sun’s harmful rays…more so than the average person who does not have pemphigus or pemphigoid.

It isn’t always a sunny day that can bring the harmful rays.  Cloudy days can be deceiving – you can get your worst sunburns through the clouds.  Reflections from the water in swimming pools, lakes, oceans, etc. increase the harmful effects of the sun’s rays as well as the reflections from the snow when skiing.

Women also need to make sure that their foundation has an SPF ingredient – this was told to me by the national makeup advisor for Dior.  I never knew this!  But it does help…even if we don’t actively stay out in the sun and are just running around doing errands.

According to the American Academy of Dermatology:

“Dermatologists recommend using a sunscreen with an SPF block of at least 30, which blocks 97% of the sun’s rays.  Just make sure it offers a broad-spectrum (UVA and UVB) protection, an SPF of 30 or greater, and is water resistant.”

Before trying to figure out which brand is the best to buy, discuss with your dermatologist. He/she can make suggestions for you based on your skin’s level of activity.

Don’t forget your ears, too!  Ear lobes are very sensitive and need protection. For those of you with scalp involvement, it is best to consult with your dermatologist who will recommend what sunscreen products are best for the scalp.  Hats are advisable when venturing outside.  Solid hats…not straw as the sun’s rays will stream through the weaves and cause damage!  Take extra care with the “driver’s arm” — you know, your arm that is exposed to the sun when you’re driving?  The sun’s rays are intensified through the glass windows. Best to be sure you are either wearing long sleeves or extra sunscreen.  If you are going in the water, sunscreen needs to be reapplied often.

UV radiation also impairs the skin’s immune system in alarming ways. Sun exposure reduces the number of watchdog cells that help recognize and respond to antigens, and alters their function so they are as effective as dozing prison guards. “This effect on immune suppression can set in even before a sunburn,” Dr. Baron said. Reference: http://www.nytimes.com/2009/05/14/fashion/14SKIN.html?pagewanted=all&_r=0

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