BioZen is developing the world’s first approved medical cure for gynecomastia

Gynecomastia, also known as ‘man boobs’ or ‘gyno’, is a common condition when boys and men grow painful breast tissue. Affecting hundreds of millions of men around the world throughout their lives, gyno accounts for one in four plastic surgeries for males [1]. It is also the single most significant treatment-limiting side-effect of prostate cancer hormone therapies [2]. Males with gyno, for any reason, have a 37% higher risk of dying than those without. Despite the scale of the problem, risky surgery is the only approved treatment [3]. BioZen is developing a novel daily pill regimen to cure the disorder and transform the lives of millions around the world.   

Industry overview and challenges 

Gyno is the growth of painful glandular breast tissue in men or boys, for which surgery is currently the only approved treatment [4]. In each of the years from 2018 to 2022, gyno was a top three reason around the world that men elected to have plastic surgery. There is also an increase in surgical procedures being performed worldwide [5]. Research estimated the global gynecomastia procedures market was worth $810.8 million in 2022 and is projected to grow at an 8.8% CAGR from 2023 to 2030 [6].  

BioZen believes that demand for gyno treatments is driven by increasing awareness and de-stigmatisation of the condition [7], a stronger emphasis in the media on body image and psychological health, and a new wave of highly effective anti-obesity drugs. The company also anticipates that the launch of the world’s first approved non-invasive cure will further spur demand. 

Gyno is the most common male breast disorder, affecting between 50% and 65% of boys and men worldwide over their lifetimes [8]. It is caused by an imbalance between oestrogen and testosterone. While gyno is usually non-cancerous condition, it is linked to many different causes of hormone changes. However, the cause is unknown in 51% of cases [9]. Critically, where there is a known pre-existing risk factor, males have a 75% higher risk of dying than those without gyno [10]. In addition, gyno is the most frequent treatment-limiting side-effect of prostate cancer hormone therapy [2]. In the largest-ever randomised study of its kind, the Early Prostate Cancer programme, gyno and associated breast pain were the most frequently cited adverse events. These primarily led to 29.3% of patients withdrawing from treatment [11]. 

Gyno typically lasts for a median of 1.9 years in pubescent boys and peaks between the ages of 13 and 14 [9]. However, it persists indefinitely to some degree in 10% of cases. It is not only painful but can have long-lasting adverse psychological consequences, including, but not limited to, depression, anxiety, disordered eating, body dissatisfaction, and reduced self-esteem [12]. Worse still, the extent of the damage has been shown to be unrelated to the size of the breast growth or adiposity [13]. 

Gyno corrective surgery is the number one corrective procedure undertaken by men in the US and globally [14]. In the UK, male breast reduction surgery is not usually available on the NHS, so it is carried out at private clinics [15]. In the US, gyno is typically covered by insurance when medically necessary and persistent after known causes have been addressed [16]. Studies have found that in the US, 35% of adolescent boys undergoing surgery for gyno were covered by insurance, compared to 85% of girls undergoing breast reduction [16]. 

Unfortunately, corrective surgery often has sub-optimal results and is no guarantee of curing the disorder. A recent study found that postoperative complications were common, occurring in 36.3% of cases [17]. 

Although gyno is the most common breast disorder affecting males, there is no approved medical cure by the United States Food and Drug Administration, European Medicines Agency or the UK’s Medicines and Healthcare Products Regulatory Agency [18]. Tamoxifen (TAM), a common drug used to treat breast cancer, can be used to treat the condition. However, it is not approved for use in gyno and at the standard recommended dose, can have serious side effects [19]. In the breast cancer setting, for instance, one in five men have been found to discontinue TAM treatment due to its side effects.  

Introducing BioZen 

BioZen is developing a revolutionary daily pill regimen to reverse the effects of the hormonal imbalance that drives gynecomastia. The company aims to make its treatment the world’s first approved, safe, cost-effective, and scalable medical cure for gyno. BioZen further anticipates that its cure, once approved, is highly likely to become the gold standard of adjunctive care for antiandrogen therapy in the prostate cancer setting. 

How does BioZen’s solution work? 

BioZen proposes a dual-treatment solution of a low dose of TAM and indole-3-carbinol (I3C) taken as a once-daily, oral pill. I3C is a phytochemical found in vegetables such as broccoli, cabbage and cauliflower.  

According to the company, TAM competes with oestrogen at the receptor binding site, whereas I3C degrades oestrogen receptors, inhibits oestrogen synthesis, enhances oestrogen excretion, and lowers the circulation of oestrogen throughout the body.  Based on pre-clinical data, the company expects the two molecules to synergise by blocking the hormonal pathway leading to breast growth holistically and with minimal side-effects. 

According to the company, BioZen has a robust IP position, with novel and inventive approaches to gynecomastia treatment, innovative dosing, known molecules with synergistic mechanisms of action, global rights, and a long patent duration.

The next steps 

BioZen has chosen to use Floww’s innovative infrastructure to facilitate its funding efforts and help it achieve its future goals.  

The company reports that it has secured a strategic partnership agreement with Syneos Health, a leading global contract research organisation. BioZen is one of 15 programmes globally that have been selected by Syneos Health, based on their internal assessment of commercial feasibility. 

**Floww Markets Limited is a company authorised and regulated by the Financial Conduct Authority (FCA). Firm reference number 980098.

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