Another Day Pharma announces promising Phase II results for topical post-prostatectomy erectile dysfunction treatment

Another Day Pharma Ltd, a company developing innovative therapies for sexual dysfunction in both men and women, today announced Phase II results for its new treatment BZ371A in post-prostatectomy erectile dysfunction. Trial results show that BZ371A in gel form can improve men’s ability to have an erection that allows sexual intercourse following radical prostatectomy due to prostate cancer.[i]

In the Phase II clinical trial in 74 men between 40 and 68 years, BZ371A met its primary endpoint of assisted erectile dysfunction (ED) either as monotherapy or in combination with tadalafil, the current standard of care. ED was assessed using the International Index of Erectile Function (IIEF) Questionnaire, domain A (erectile function section) (IIEF-EF) and success was defined as the percentage of men experiencing an increase of more than 4 points.   

The men who were randomised to receive combination therapy (BZ371A + tadalafil) after surgery were 10 times more likely to respond after 30 days of treatment compared with tadalafil alone: 38% success rate vs 4% success rate (p<0.05). BZ371A monotherapy was also superior to tadalafil alone: 15% success rate at 30 days compared with 4%, and 32% success rate at 60 days compared with 13%. Due to its localised topical application, BZ371A was shown to be well-tolerated with no serious adverse events and no adverse events that led to discontinuation of the medication.   

BZ371A is a synthetic non-hormonal peptide derived from the venom of the Phoneutria nigriventer spider, known for causing priapism - long-lasting painful erection - in bite victims. BZ371A can induce an erection even in the absence of sexual stimulation. It stimulates production of nitric oxide (NO), triggering production of cyclic guanosine 3’,5-monophosphate (cGMP) which provokes endothelial muscle relaxation and increased blood flow, leading to an erection. This new and unique mechanism of action makes BZ371A particularly valuable for men whose neural pathways have been compromised, such as after prostatectomy.   

Although BZ371A has the potential to function independently, its mechanism of action is complementary to phosphodiesterase type 5 (PDE5) inhibitors such as tadalafil so the two treatments can be taken together, leading to a stronger erection.  “We are delighted that these trial results show that BZ371A is proving to be a well-tolerated, effective option for men undergoing radical prostatectomy, either as monotherapy or concomitantly with tadalafil,” said Paulo Lacativa, clinical researcher at Biozeus Biopharmaceuticals in Brazil who developed the treatment. “The results support the advancement of BZ371A into Phase III trials and reinforce its potential to address other forms of ED.”   

“BZ371A offers a new way of treating ED that we hope will benefit, in the future, the many men who don’t respond to or are unable to take PDE5-inhibitors”, said Carlos Sanchez, Director at Another Day Pharma. “We are now seeking strategic partnerships with pharmaceutical companies interested in licensing or co-developing this product.”   

Around 60,000-70,000 men in Europe[ii],[iii],[iv],[v],[vi]and 161,000 in the US[vii] undergo radical prostatectomy every year and more than 90% of them will have ED immediately after surgery.[viii] These men are at risk of irreversible erectile tissue damage without early intervention.[ix] Surgical damage to the nerves and blood vessels can lead to long-term loss of erectile function and current treatment with the PDE5-inhibitor tadalafil daily for 18-24 months[x] offer limited benefit  since no treatment improves recovery of spontaneous erections.[xi],[xii] Patients are often left with few effective options to prevent progression of tissue damage and permanent loss of erectile capability.     

ENDS                            

About erectile dysfunction (ED) 

The global prevalence of Erectile dysfunction (ED) is 3–76.5%[xiii] and thus it affects up to 87M men in the US and Europe. Current first-line treatment is with oral PDE5-inhibitors such as sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra). However, 35% of ED sufferers are PDE5i resistant and for 15% PDE5is are contraindicated.[xiv] Other treatment options, like injectable medications or vacuum devices, may be considered in more severe cases. 

About Another Day Pharma Ltd 

Another Day Pharma Ltd (https://www.anotherdaypharma.com) is a UK-based leader in personal health innovation. The company is dedicated to pioneering innovative therapies for sexual dysfunction in both men and women-offering new hope where existing options fall short or don’t exist. Its international team of researchers, clinical trial specialists, and pharmaceutical leaders is united by a passion to deliver radical innovation to one of the world’s largest unmet medical needs, impacting millions of individuals and couples worldwide.  The company recently entered a partnership with Biozeus Biopharmaceuticals S.A, a Brazilian-based clinical stage biotechnology company developing a portfolio of novel therapeutic peptides to address significant unmet medical needs, including BZ371A. BZ371A is also in a Phase II trial for the treatment of female sexual dysfunction and Another Day Pharma aims to accelerate the global reach of this groundbreaking therapeutic for both men and women.   

References: 

[i] Clinicaltrials.gov. Available at https://clinicaltrials.gov/study/NCT05558007?term=BZ371A%20&rank=3  

[ii] Ploussard G et al. A 5-Year Contemporary Nationwide Evolution of the Radical Prostatectomy Landscape. Eur Urol Open Sci . 2021 Oct 25;34:1–4. 

[iii] Guijarrohttps://www.elsevier.es/en-revista-actas-urologicas-espanolas-english-392-articulo-population-based-study-morbidity-mortality-S2173578622001196?utm_source=chatgpt.com A et al. Population based study of morbidity and mortality rates associated to radical prostatectomy cases in Spain. Actas Urológicas Españolas (English Edition) 2022; 46(10): 587-658. 

[iv] Haidinger G et al. Radical prostatectomies in Austria, 1997–2004. BMC Research Notes 2008;1:48.  [v] Etzioni R et al. Increasing use of radical prostatectomy for non-lethal prostate cancer in Sweden. Clin Cancer Res. 2012; 18(24):6742–6747. 

[vi] Anderson JB et al for the Prostate Cancer Advisory Group. BAUS, Advice on the Development of Robotic Assisted Radical Prostatectomy in England. Summer 2011. Available at https://www.baus.org.uk/_userfiles/pages/files/Publications/PCAGRoboticProstatectomyinEngland.pdf 

[vii] DeFrances CJ, Hall MJ. 2002 National Hospital Discharge Survey. Advance Data from Vital and Health Statistics; no.342. National Center for Health Statistics: Hyattsville, MD, 2004 Adv Data 2004; 21: 1–29. 

[viii] Vaznesensky, M, Annam K, Kreder KJ. Understanding and Managing Erectile Dysfunction in Patients Treated for Cancer. J. Oncol Pract. 2016: 12(4):297-304. 

[ix] Salonia A, et al. Sexual Rehabilitation After Treatment for Prostate Cancer—Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015). J Sex Med 2017; 14:285-315. 

[x] Rambhatla A et al. Rationale for phosphodiesterase 5 inhibitor use post-radical prostatectomy: experimental and clinical review. Inter J Impotence Res. 2008; 20:30–34. 

[xi] Gabrielsen JS. Penile Rehabilitation: the "up"- date. Curr Sex Health Rep 2018; 10(4):287–92 ;  

[xii] Salonia A, et al. Sexual Rehabilitation After Treatment for Prostate Cancer—Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015). J Sex Med 2017; 14:285-315. 

[xiii] Kessler A, et al. The global prevalence of erectile dysfunction: a review. BJUI 2019; 124(4): 587-599 

[xiv] National Library of Medicine. “Treating erectile dysfunction with PDE5i fail”; “A comparison of the available phosphodiesterase-5 inhibitors in the treatment of erectile dysfunction”