Phase I Trials for BZ371A to Erectile Dysfunction

LACK OF SYSTEMIC EXPOSURE CONFIRMS THAT BZ371A CAN ATTEND CURRENTLY UNATTENDED/CONTRAINDICATED ERECTILE DYSFUNCTION PATIENTS FOR CURRENTLY MARKETED DRUGS RIO DE JANEIRO, BRAZIL, JAN. 16TH, 2023 – BIOZEUS BIOPHARMACEUTICAL S.A., A BIOPHARMACEUTICAL COMPANY DEVELOPING BZ371A, A NEW DRUG CLASS ABLE TO INCREASE LOCAL BLOOD FLOW AFTER TOPICAL APPLICATION, ANNOUNCES RESULTS FROM PHASE I TRIAL. BZ371A IS BEING DEVELOPED FOR THE TREATMENT OF ERECTILE DYSFUNCTIONS AND WAS APPLIED TOPICALLY IN THE GENITAL AREA OF MEN AND WOMEN CONFIRMING LOCAL SAFETY, TOLERABILITY AND LACK OF SYSTEMIC EXPOSURE. CURRENTLY ORAL PDE5I (VIAGRAⓇ; CIALLIS Ⓡ,...) IS A CLASS OF DRUG THAT WORKS FOR 70% OF ERECTILE DYSFUNCTION PATIENTS. NEVERTHELESS, 30% OF THOSE PATIENTS ARE DROP-OUT OR CONTRA INDICATED TO PDE5I, DUE TO ITS SIDE EFFECTS THAT ARE BASED ON ITS SYSTEMIC EXPOSURE: HYPOTENSION, FAINTNESS, HEADACHE, ETC… BZ371A INCREASES PENILE BLOOD FLOW WITHOUT SYSTEMIC EXPOSURE. THIS SAFETY PROFILE WAS ALREADY PROVED IN ANIMALS AND CONFIRMED IN THIS REGULATED HUMAN TRIAL, CONSOLIDATING BZ371A ABILITY TO ATTEND CURRENTLY UNATTENDED PATIENTS. BASED ON ITS MECHANISM OF ACTION, BZ371A CAN INCREASE LOCAL BLOOD FLOW WITHOUT THE NEED OF STIMULUS. THIS UNIQUE FEATURE IS WELL PROVED IN THE ANIMALS’ MODELS AND WILL ALLOW BZ371A TO BE APPLIED AS A SUPPORTIVE THERAPY TO MAINTAIN PENILE INTEGRITY AND ALLOW SEXUAL REHABILITATION OF PATIENTS THAT UNDERWENT RADICAL PROSTATECTOMY DUE TO PROSTATE CANCER. FOR THESE PATIENTS, SEXUAL STIMULI IS JEOPARDIZED AFTER SURGERY AND, FOR THE PATIENT'S SUCCESSFUL FUTURE SEXUAL REHABILITATION, IT DEPENDS ON A PERIODIC PENILE ERECTION. DUE TO NERVE DAMAGE FROM THE SURGERY, THE CURRENT MARKETED DRUGS OBTAIN LOW TO NO EFFECT IN THIS POPULATION. THUS, BZ371A PROPERTIES ARE CHARACTERIZED TO BE THE MOST SUITABLE TO TREAT THIS UNATTENDED POPULATION. IN ADDITION, BZ371A OBTAINS SYNERGISTIC EFFECTS WITH PDE5I (VIAGRA Ⓡ , CIALIS Ⓡ , ETC). THIS EFFECT SHALL ALSO OPEN A NEW OPPORTUNITY FOR PATIENTS IN WHICH THE CURRENTLY MARKETED DRUGS NO LONGER BRING ADEQUATE RESULTS, FOR EXAMPLE IN PATIENTS WITH SEVERE DIABETIC. IN THIS PHASE I STUDY, WOMEN'S SAFETY WAS ALSO CONFIRMED DUE TO POSSIBLE CONTACT FROM SEXUAL INTERCOURSE. HOWEVER THIS DATA PROVIDES A BASIS FOR A FUTURE BZ371A DEVELOPMENT ASSOCIATED WITH THE TREATMENT OF FEMALE SEXUAL AROUSAL DISORDER. "FEMALE SEXUAL DYSFUNCTION AFFECTS UP TO 40% OF SEXUALLY ACTIVE WOMEN AND IT DOES NOT OBTAIN PROPER EFFECTIVE TREATMENT. INCREASE IN LOCAL BLOOD FLOW AND VASCULARIZATION WAS ALREADY PROVED IN PREVIOUS STUDIES AND MAY BE AN OPPORTUNITY TO BE EXPLORED BY BIOZEUS IN THE NEAR FUTURE" – SAYS DR. PAULO LACATIVA, BIOZEUS CEO. BZ371A BZ371A IS A FIRST-IN-CLASS, EASILY SYNTHESIZED PEPTIDE, THAT IS PART OF A NEW AND UNIQUE THERAPEUTIC CLASS CALLED NITRIC OXIDE SYNTHASE (NOS) ENHANCERS. BZ371A TOPICAL APPLICATION RESULTS IN LOCAL VASODILATATION AND INCREASES LOCAL BLOOD FLOW, INDEPENDENT OF ANY STIMULUS, FACILITATING PENILE ERECTION AND ACTING IN THE TREATMENT OF ERECTILE DYSFUNCTION. ALSO, BZ371A CAN BE USED IN COMBINATION WITH THE CURRENTLY AVAILABLE PDE5I (VIAGRA R, CIALLYS R, ….) THERAPY, DUE TO ITS SYNERGIC EFFECT BIOZEUS BIOPHARMACEUTICAL S.A. BIOZEUS IS A CLINICAL STAGE BIOTECH COMPANY DEVELOPING A NEW THERAPEUTIC CLASS PLATFORM BASED ON TOPICAL APPLICATION AND WITH THE UNIQUE MECHANISM OF ACTION OF INCREASING LOCAL VASODILATATION AND INCREASING LOCAL BLOOD FLOW, INDEPENDENT OF ANY STIMULUS AND WITHOUT SYSTEMIC EXPOSURE. THE WELL-DEFINED MOA IS BASED ON INCREASING ACTIVITY AND GENE EXPRESSION OF AN ENDOGENOUS PROTEIN WITH SAFETY AND EFFICACY ALREADY PROVED IN ANIMAL AND HUMAN BASED ON TOPICAL USE – SKIN; EYE DROP AND INHALATION - LUNG. LICENSING OPPORTUNITY BIOZEUS BUSINESS STRATEGY IS BASED ON DEVELOPING BZ371A FOR THE TREATMENT OF ERECTILE DYSFUNCTION THROUGH PHASE II TRIAL AND LICENSE OUT THE EXCLUSIVITY TO EXPLORE BZ371A FOR SEXUAL DYSFUNCTION (BOTH ERECTILE DYSFUNCTION AND FEMALE SEXUAL AROUSAL DISORDER) TO LOCAL/REGIONAL PARTNERS. BASED ON THIS STRATEGY, BIOZEUS HAS ALREADY LICENSED BZ371A EXCLUSIVE COMMERCIAL RIGHTS FOR CENTRAL AMERICA, SOUTH AMERICA & CANADA. CURRENTLY, BIOZEUS IS LOOKING FOR PARTNERS IN THE EUROPEAN UNION AND UNITED STATES. IN THE INTEREST OF POSSIBLE PARTNERSHIPS AND/OR QUESTIONS, PLEASE CONTACT THE FOLLOWING: [email protected] OR [email protected].

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