RPh201 / Regenera - LARVOL DELTA

Epidemic of Subclinical Ovulatory Disturbances During SARS-COV2 Pandemic—an Experiment of Nature (ENDO 2022) - "In MOS, ovulation was assessed by 3-fold increased follicular (FP)-to-luteal (LP/premenstrual) urinary progesterone (PdG); in MOS2, by validated Quantitative Basal Temperatur"

Cardiovascular • CNS Disorders • Depression • Endometrial Cancer • Infectious Disease • Infertility • Long-acting Reversible Contraceptives • Mood Disorders • Myocardial Infarction • Novel Coronavirus Disease • Oncology • Osteoporosis • Pain • Psychiatry • Respiratory Diseases • Sexual Disorders • Sleep Disorder • Solid Tumor

Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) (clinicaltrials.gov) - P2; N=165; Terminated; Sponsor: Regenera Pharma Ltd; Trial completion date: Aug 2021 ➔ Sep 2020; Recruiting ➔ Terminated; Trial primary completion date: Apr 2021 ➔ Sep 2020; Terminated by Sponsor

Clinical • Trial completion date • Trial primary completion date • Trial termination • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain

Delayed (21 Days) Post Stroke Treatment With RPh201, a Botany-Derived Compound, Improves Neurological Functional Recovery in a Rat Model of Embolic Stroke. (PubMed, Front Neurosci) - "Our data demonstrated that RPh201 has a therapeutic effect on improvement of functional recovery in male ischemic rats even when the treatment was initiated 21 days post stroke. Enhanced axonal and myelination densities by RPh201 in ischemic brain may contribute to improved stroke recovery."

Journal • Preclinical • Cardiovascular • Ischemic stroke • MBP • NEFH

Controversies on neuroprotection therapy in non-arteritic anterior ischaemic optic neuropathy. (PubMed, Br J Ophthalmol) - "Unfortunately, in spite of all the experimental and clinical research on neuroprotection agents in NA-AION so far, we have no scientifically proven evidence of neuroprotection agents showing any benefit in the human clinical studies so far."

Journal • Review • Cardiovascular • Gene Therapies • Ocular Inflammation • Optic Neuritis • Pain

Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Regenera Pharma Ltd; Active, not recruiting ➔ Recruiting; Phase classification: P3 ➔ P2; Trial completion date: Dec 2020 ➔ Aug 2021; Trial primary completion date: Nov 2020 ➔ Apr 2021

Clinical • Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Gene Therapies • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Reperfusion Injury

Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy. (PubMed, J Neuroophthalmol) - P2 | "This Phase 2a was designed to assess safety, feasibility, and explore potential efficacy signals in treating previous NAION with RPh201. No safety concerns were raised. The results support a larger trial in patients with previous NAION."

Clinical • Journal • P2a data • Diabetes • Diabetic Macular Edema • Diabetic Retinopathy • Gene Therapies • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Reperfusion Injury • Retinal Disorders

A Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease (clinicaltrials.gov) - P2; N=83; Completed; Sponsor: Regenera Pharma Ltd; Recruiting ➔ Completed; Trial completion date: Jul 2020 ➔ Mar 2020

Clinical • Trial completion • Trial completion date • Alzheimer's Disease • Cardiovascular • CNS Disorders • Dementia • Hematological Disorders • Reperfusion Injury • Tauopathies And Synucleinopathies

Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) (clinicaltrials.gov) - P3; N=234; Active, not recruiting; Sponsor: Regenera Pharma Ltd; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Delayed (21 Days) Post Stroke Treatment With RPh201, A Botany-Derived Compound, Improves Neurological Functional Recovery in a Rat Model of Embolic Stroke (ISC 2020) - "Our data demonstrated that RPh201 has a therapeutic effect on improvement of functional recovery in male ischemic rats even when the treatment was initiated 21 days post stroke. Enhanced axonal and myelination densities by RPh201 in ischemic brain may contribute to improved stroke recovery."

Preclinical • MBP

Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) (clinicaltrials.gov) - P3; N=234; Recruiting; Sponsor: Regenera Pharma Ltd; Trial completion date: May 2020 ➔ Dec 2020; Trial primary completion date: Nov 2019 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date

A First-in-Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers. (PubMed, Clin Pharmacol Drug Dev) - "No deaths or adverse events related to changes in vital signs or electrocardiograms were reported. No occurrences of suicidal behavior or ideation were reported."

Clinical • Journal • P1 data

A Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease (clinicaltrials.gov) - P2; N=81; Recruiting; Sponsor: Regenera Pharma Ltd; Trial completion date: Apr 2019 ➔ Jul 2020; Trial primary completion date: Feb 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date