leflutrozole (BGS-649) / Mereo Biopharma, ReproNovo - LARVOL DELTA

NOVA-NOA: A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia (clinicaltrials.gov) - P1/2 | N=15 | Not yet recruiting | Sponsor: Martin Blomberg Jensen

New P1/2 trial • Infertility • Sexual Disorders

The NOVA-NOA Trial nA Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia (clinicaltrialsregister.eu) - P1/2 | N=15 | Not yet recruiting | Sponsor: Herlev Hospital

New P1/2 trial • Infertility • Sexual Disorders

ETNA: A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function in Men With Hypogonadotropic Hypogonadism (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: ReproNovo Aps | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders

ETNA: A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function in Men With Hypogonadotropic Hypogonadism (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: ReproNovo Aps

New P2 trial • Endocrine Disorders

Leflutrozole in Male Obesity-Associated Hypogonadotropic Hypogonadism: Ph 2b Double-Blind Randomised Controlled Trial. (PubMed, Eur J Endocrinol) - "Of 2103 screened, 271 were randomised, 81 discontinued. Demographic characteristics were similar across groups. Mean BMI was 38.1 kg/m2, and TT 7.97 nmol/L. The primary endpoint was achieved in all leflutrozole-treated groups by 24 weeks with a dose-tiered response; mean TT 15.89; 17.78; 20.35 nmol/L, for leflutrozole 0.1 mg, 0.3 mg, 1.0 mg groups respectively, versus 8.04 nmol/L for placebo. LH/FSH significantly increased in leflutrozole vs placebo groups. No improvement in body composition or sexual dysfunction were observed. Semen volume/total motile sperm count improved with leflutrozole vs placebo. Treatment-emergent adverse events, more common in leflutrozole-treated groups included, raised haematocrit, hypertension, increased PSA, and headache. Some reduction in lumbar bone density was observed with leflutrozole (mean -1.24%, -1.30%, -2.09%), and 0.66% for 0.1 mg, 0.3 mg, 1.0 mg, and placebo, respectively, without change at the hip. This RCT of leflutrozole in OHH..."

Journal • Cardiovascular • Endocrine Disorders • Genetic Disorders • Hypertension • Obesity • Pain • Sexual Disorders

Obesity and 'functional hypogonadism' - mechanisms and management: Commentary on EJE-22-1110 "Leflutrozole in Male Obesity-Associated Hypogonadotropic Hypogonadism: Ph 2b Double-Blind RCT". (PubMed, Eur J Endocrinol) - No abstract available

Journal • Endocrine Disorders • Genetic Disorders • Obesity

"It’s possible. Licensed from @Novartis Setrusumab, acumapimod, leflutrozole" (,@ej23ny)

A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis (clinicaltrials.gov) - P2; N=27; Terminated; Sponsor: Mereo BioPharma; N=68 ➔ 27

Clinical • Enrollment change • Endometriosis • Gynecology • Musculoskeletal Pain • Pain

Beneficial Effect on Sperm Production of Leflutrozole in Men with Obesity-Associated Secondary Hypogonadotropic Hypogonadism: Results from a Phase II Study (ENDO 2019) - P2b; "In contrast to suppression of spermatogenesis seen with exogenous T therapy, leflutrozole restores normal endogenous physiologic T levels whilst increasing FSH/LH, with positive effects on semen fertility parameters in men with OHH. A 24-wk, blinded extension study is currently ongoing.*Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins."

P2 data

Beneficial Effect on Sperm Production of Leflutrozole in Men with Obesity-Associated Secondary Hypogonadotropic Hypogonadism: Results from a Phase II Study (ENDO 2019) - P2b; "In contrast to suppression of spermatogenesis seen with exogenous T therapy, leflutrozole restores normal endogenous physiologic T levels whilst increasing FSH/LH, with positive effects on semen fertility parameters in men with OHH. A 24-wk, blinded extension study is currently ongoing."

P2 data

"Mereo $MPH BGS-649 Phase 2b data to be Presented at ENDO 2019 https://t.co/JFT0DQ2Ifi Silence Tx $SLN SLN124 granted Orphan Drug Designation by EMA https://t.co/feBAvEkJSU Genedrive $GDR Trading update https://t.co/Hk51SNksvv" (,@BiotechRadar)

European regulatory • Orphan drug • P2 data