Tengsheng Bo Pharma announced the top-line results of a Phase 1 study of BRII-296, a long-acting therapy for postpartum depression

Brii Biosciences (hereinafter referred to as "Tengsheng Biosciences" or the "Company", stock code: 2137.
HK), a multinational company dedicated to developing innovative therapies for unmet patient needs and major public health diseases, announced on September 26 that it is developing top-line results
from a Phase 1 study of BRII-296, a long-acting single-shot therapy for the treatment of postnatal depression (PPD).
The data show that a single intramuscular (IM) injection of 600 mg of BRII-296 achieves linear dose, early drug absorption, gradual and prolonged release curves without dose titration or gradual reduction, laying a solid foundation
for achieving clinical efficacy of PPD treatment at this dose.
The selected dose regimen will be evaluated
in a Phase 2 clinical trial expected to begin this year.

BRII-296 is a novel γ-aminobutyric acid A (GABAa) receptor-positive allosteric modulator (PAM) with a unique long-acting dosage form that eliminates the need to stop breastfeeding and makes the drug effective
for weeks after the patient finishes the injection.
BRII-296 is designed to rapid, adequate, and sustained control of depressive symptoms of PPD, and BRII-296 may have substantial clinical advantages
over existing treatment options.

Dr.
Ma Ji, vice president of preclinical development and clinical pharmacology, said, "In the United States, about 900,000 women suffer from postpartum depression every year, and the existing standard treatment is not effective, and patients often need to be hospitalized, repeated treatment and daily medication
.
We are encouraged by the potential to offer new treatment options
to these patients.
With one-time outpatient treatment, BRII-296 may be effective in controlling and treating a variety of depressive symptoms with favorable safety and tolerability profiles, including minimal drug exposure
in lactating infants.
Combined with this information, we have even stronger reason to believe that BRII-296 can redefine the treatment landscape
of PPD.
"

Dr.
Aleksandar Skuban, Head of the Central Nervous System Disease Therapeutics Area at Tengsheng Bo Pharma, said, "The initial results of this study are an important step forward for us to continue the robust and rigorous Phase 2 study of BRII-296 later this year, which will also incorporate the patient's underlying experience and preferences
.
" This comprehensive approach to development is critical in areas such as PPD, where there are often considerable barriers to patient access to medical care, due in part to widespread social stigma and a lack of disease awareness
.
This project reinforces Tengsheng Biopharma's commitment to combining scientific innovation and patient insight to enrich our drug development in the field of spiritual health diseases such as PPD, and the extensive layout
of global public health product pipelines.
"

Data from healthy subject cohorts 1-15 were presented in a poster titled "Safety, tolerability and pharmacokinetics of Brexanolone aqueous suspension BRII-296 for Exxanolone in healthy adult subjects" at the International Marcé Society Conference, held in London, United Kingdom, September 19-23, 2022
。 Full data from the Phase 1 study will be presented
at a scientific meeting later this year.

About the Phase 1 trial of BRII-296

The completed open-label, single-dose escalation Phase 1 study evaluated the safety, tolerability, and pharmacokinetics
of BRII-296 as a single-injection treatment option for PPD in 116 participants enrolled in 16 cohorts.
Healthy adults are given one or more intramuscular concentrations of three formulations (100 mg/mL, 200 mg/mL, and 300 mg/mL) for total dose levels of 30 mg, 75 mg, 100 mg, 200 mg, 300 mg, and 600 mg
.
In addition, trials evaluated oral prophylaxis or combination therapy with BRII-296 with topical steroids (methylprednisolone acetate in combination or in combination) to mitigate local injection site reactions (ISRs).

Topical steroids have been shown to be effective in controlling injection site reactions (ISRs).

Of the 116 participants, 98 reported adverse reactions (TEAEs) arising from treatment, mostly thought to be drug-related and attributed to injection site reactions (ISRs).

Most injection site reactions (ISRs) were mild to moderate and did not lead to early study termination
.
There were no life-threatening adverse effects (TEAE), adverse effects leading to early study termination (TEAE), serious adverse effects (SAE), or death
.

About postpartum depression

Postpartum depression (PPD) is the most common mental illness
affecting the postpartum population.
PPD poses serious physical and mental health risks to women, affecting about 900,000 women in the United States each year, including those who
have had miscarriages or stillbirths.
In fact, suicide and drug overdose are the leading causes of
death in the first postpartum year of women.
Some healthcare providers believe that the prevalence of PPD could be at least twice as
high, taking into account unreported and untreated cases.
PPD can also have a negative impact on the mother-infant relationship and can cause long-term child development problems
.
In addition to the prevalence and social impact of PPD, currently approved treatment options remain limited and often severely interfere with patients' daily lives, including the need for hospitalization, repeated treatment, and daily medication
.

About BRII-296

BRII-296 is a novel, single-injection therapeutic candidate in development for the treatment and prevention of postpartum depression (PPD).

BRII-296, a γ-aminobutyric acid a (GABAa) receptor-positive allosteric modulator (PAM) designed to rapid, adequate, and sustained control of depressive symptoms of PPD, may have better adherence, convenience, and fewer
side effects than current standard care.
The evaluation of BRII-296 for the treatment of PPD will continue in an upcoming Phase 2 study, followed by studies
of PPD prevention.