The FDA approves the first ever postpartum depression product. Positive results from Dermira’s atopic dermatitis product Lebrikizumab

News We Loved to Hear

 The First and Only Approval of a Specific Product for Postpartum Depression

ZULRESSOTM

The FDA granted approval of Sage Therapeutics’ (SAGE) ZULRESSOTM (brexanolone) injection. A product for the treatment of the condition known as postpartum depression (PPD). This makes Zulresso the first and only medicine specifically approved by the FDA to treat PPD; the most common medical complication of childbirth.

The product is expected to be available in late June following scheduling by the U.S. Drug Enforcement Administration which is expected to occur within 90 days. To read the press release click on the following link: https://www.businesswire.com/news/home/20190319005938/en/

PPD can affect women during pregnancy or after childbirth. PPD is estimated to affect approximately one in nine women who have given birth in the U.S. Symptoms may include sadness, anxiety, irritability and withdrawing from friends or family. Affected mothers have trouble bonding with their babies. They sometimes harm themselves and in rare instances, their newly born babies.

Up to 50% of PPD-affected mothers may go undiagnosed. In 2016 ZULRESSO was also granted Breakthrough Therapy Designation status underscoring the significant unmet need in women with PPD.

The FDA approval of ZULRESSO is based on findings from three multicenter, randomized, double-blind, parallel-group, placebo-controlled trials designed to evaluate the safety and efficacy of ZULRESSO in women with moderate and severe PPD. In all trials, at all doses, Zulresso achieved the primary endpoint; a significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score (a common measure of depression severity) at 60 hours compared to placebo. A reduction of depressive symptoms was also seen as early as 24 hours and Zulresso maintained effect through the 30-day follow-up. The most common adverse events in the studies were sleepiness, dry mouth, loss of consciousness and flushing.

About Postpartum Depression (PPD)

PPD is the most common medical complication of childbirth. PPD is a distinct and readily identified major depressive disorder that can occur during pregnancy or after giving birth. Expert opinions vary as to the timing of the onset of PPD. Ranging from onset during pregnancy up to 4-weeks postpartum and from onset during pregnancy up to 12-months postpartum. PPD may have devastating consequences for a woman and for her family. These may include significant functional impairment, depressed mood and/or loss of interest in her newborn as well a associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. Suicide is the leading cause of maternal death following childbirth. PPD affects approximately one in nine women who have given birth in the U.S. and 400,000 women annually. More than half of these cases may go undiagnosed without proper screening. 

Zulresso is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. It is the first medicine specifically approved by the United States FDA for the treatment of PPD. In Europe Zulresso has been granted PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA).

Prohost Observations

Great news in meeting an unmet huge need that many women and their newly born babies suffer from terribly. In addition to the currently approved product Zulresso, the firm has 8 other products; all in clinical trials and one in preclinical. Two of the products are in Phase 3 and two are in Phase 2 and three are in Phase 1.

The stock is trading on the NASDAQ under the symbol SAGE. The stock is trading unchanged at $156.10 with a Market Cap. over  $7 billion.

It looks as if investors believe that the approval has already been accounted for in the firm’s stock price and its market.

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Finally the Clinic Has Specific Non-Steroidal Products for Atopic Dermatitis

After centuries of lacking specific treatments for atopic dermatitis (a severe kind of eczema) in the dermatology clinic; suddenly, several non-steroid products demonstrate efficacy with two products being approved. One of the approved products belongs to Regeneron (REGN) and Sanofi (SNY). The second belongs to AstraZeneca (AZN).   

On Monday, March 18, a firm called Dermira (DERM) announced positive results from a Phase 2b dose-ranging study of its product lebrikizumab in adult patients with moderate-to-severe atopic dermatitis. The firm added that all three dosages of the drug met the primary endpoint showing improvements in the Eczema Area and Severity Index (EASI) score compared to placebo.

The drug’s safety profile was consistent with what demonstrated in prior studies that the drug was well tolerated in patients with moderate-to-severe atopic dermatitis.

Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind interleukin-13 (IL-13) with high affinity specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex which inhibits downstream signaling. IL-13 is believed to promote type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.

Lebrikizumab Phase 2b Study Results

Each of the lebrikizumab doses, 125 mg every four weeks, 250 mg every four weeks and 250 mg every two weeks, met the primary endpoint of showing improvement in the severe eczema over placebo with statistical significance.   

The secondary endpoints for the 125 mg lebrikizumab dosing arm did not meet statistical significance.

Commenting on the results, Tom Wiggans, Chairman and Chief Executive Officer of Dermira, stated that the clinical profile observed in the study made the firm believe that lebrikizumab has the potential to be a best-in-disease therapy for atopic dermatitis.

Following an end-of-Phase 2 meeting with the FDA, Dermira, plans to initiate a Phase 3 clinical development program for lebrikizumab by the end of 2019.

About Atopic Dermatitis

Atopic dermatitis is the most common and severe form of eczema; a chronic inflammatory condition that might start as early as childhood and continue into adulthood. A moderate-to-severe form of the disease is characterized by rashes on the skin that often cover much of the body and includes redness, cracking, dryness and intense, persistent itching. The skin condition can have a negative impact on a patients’ mental and physical functioning limiting their daily activities and health-related quality of life. Patients with moderate-to-severe atopic dermatitis have reported a larger impact on quality of life than patients with psoriasis.

Prohost Observations

The news has been a blessing for Dermira’s shareholders. Especially those who were there when the stock was cremated after the firm’s investigational drug olumacostat failed the clinical trial on acne. As a matter of fact the news rallied the stock which jumped up from $5 before the announcement of the news to close sat $13.88 today.

Having said that we must realize that the product is still in mid-Phase trials and, if the Phase 3 trials start as soon as possible and its results confirm those in Phase 2b trial, we expect the drug to take around two and a half years to reach the market, in case it is granted approval.   

Although we believe that the news is positive we also believe that it is not fair to claim that lebrikizumab is superior to the other newly approved atopic dermatitis product.

We intend to review all three new atopic dermatitis products in the upcoming Prohost Letter. We remind that Regeneron and AstraZeneca products have already been approved.    

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MRK: The stock traded slightly negative yesterday and this morning as the ovarian clinical trials did not meet the endpoints. Still we believe the stock will reach the Prohost 2019 target as seen in the Prohost Portfolio #1

RGNX: This gene therapy firm has staged a rally today as the stock was upgraded from outperform to strong buy by Raymond James.

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