TECHNOLOGY

Biozeus developed a patented, small synthetic, peptide platform named "BZ371". This platform offers a novel and unique therapeutic class in different areas of treatment, such as (1) sexual dysfunction, (2) eye diseases and (3) lung diseases. 

BZ371 platform is composed by a new class of therapeutic compounds that acts locally, through topical application, restoring the physiological NO production, without systemic exposure. The peptides of this platform are called Nitric Oxide Synthase-enhancers, being able to induce the endogenous NO production in the target tissue. This unique mechanism of action offers a more constant, safer and prolonged NO supply, solving problems that have plagued NO-based drug development.

BZ371A is a topical therapy that increases blood flow in the corpus cavernosum, promoting vasodilation and enhancing erectile function. Therefore, this technology can be applied to the treatment of erectile dysfunction (ED), either as a monotherapy or in combination with phosphodiesterase type 5 inhibitors (PDE5i), due to its synergistic effect.

As its first clinical indication, patients who have undergone radical prostatectomy were selected due to the high unmet medical need and the lack of effective therapeutic options currently available. In this population, BZ371A may be used as a supportive therapy to help preserve penile integrity following radical prostatectomy. Biozeus has recently completed a Phase 2 clinical study for this indication
(ClinicalTrials.gov Identifier: NCT05558007).

A second indication under development is Female Sexual Interest/Arousal Disorder (FSIAD). Biozeus has completed a Phase 2a clinical study evaluating BZ371A in women with FSIAD.

Both Phase 2 studies demonstrated outstanding results, showing that BZ371A is an effective and safe therapeutic option for the treatment of sexual dysfunctions.

 (ClinicalTrials.gov Identifier: NCT06116045)

Additional potential indications include:
(i) patients with erectile dysfunction who are intolerant or non-responsive to PDE5 inhibitors (such as sildenafil), including populations with comorbidities such as hypertension and diabetes mellitus.

BZ371A peptide eye drop induces IOP reduction and neuroprotective effect around the optical nerve head. Our compound is directed for the treatment of Retinal DIseases (Diabetic Retinopathy, Dry Age Macular Disease and Glaucoma). BZ371A was granted an Orphan Drug Designation (ODD) by the FDA for the treatment of Anterior Ischemic Optic Neuropathy (AION). 

Currently, this project is in preclincal stage.

BZ371B is administered by inhalation, acting as a local vasodilator, and a selective bronchodilator with anti-inflammatory activity. B371B reduces pulmonary arterial pressure being a new therapeutic approach for patients with Pulmonary Arterial Hypertension (PAH). Compared to other PAH drugs: 

(i) BZ371B does not cause systemic hypotension and can be used in combination with current marketed PAH drugs; (ii) BZ371B has a selective pulmonary action, improving ventilation/perfusion ratio. These advantages elects BZ371B as the only therapeutic option for patients with PAH group 3 (PAH secondary to pulmonary diseases, a currently unattended medical need).

Currently, this project is in preclincal stage. 

Other indications are: (i) Acute Respiratory Distress Syndrome (ARDS- like secondary to COVID-19) - BZ371B has the potential to reduce or avoid the hospitalization period in ICU; (ii) Chronic Obstructive Pulmonary Disease (COPD) with or without PAH.