BC007 / Berlin Cures - LARVOL DELTA

Safety, tolerability and clinical effects of rovunaptabin, also known as BC007 on fatigue and quality of life in patients with Post-COVID syndrome (reCOVer): a prospective, exploratory, placebo-controlled, double-blind, randomised phase IIa clinical trial (RCT). (PubMed, EClinicalMedicine) - P2 | "As this proof-of-concept study showed effects on the patient-centred endpoint PCS and a good safety profil, subsequent studies are needed to confirm these results in a larger cohort. German Federal Ministry of Education and Research, German Research Foundation."

HEOR • Journal • P2a data • Fatigue • Infectious Disease • Novel Coronavirus Disease

BLOC: To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID (clinicaltrials.gov) - P2 | N=119 | Completed | Sponsor: Berlin Cures GmbH | Active, not recruiting ➔ Completed

Trial completion • Novel Coronavirus Disease

BLOC: To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID (clinicaltrials.gov) - P2 | N=119 | Active, not recruiting | Sponsor: Berlin Cures GmbH | Trial completion date: May 2025 ➔ Nov 2024 | Trial primary completion date: Apr 2025 ➔ Aug 2024

Trial completion date • Trial primary completion date • Novel Coronavirus Disease

Persistence of autoantibodies directed against the beta-1-adrenoceptor in patients with heart failure after treatment with BC 007 (Rovunaptabin). Results of a phase IIa study. (HEART FAILURE 2024) - "In pts with moderate to severe heart failure in whom AABs directed against B1-A have been detected, it is very likely that these will not disappear spontaneously. BC 007 is highly effective in neutralizing AABs directed against B1-A. The recurrence of AABs after several months of a single treatment can effectively be prevented by a second dose."

Clinical • P2a data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

BLOC: To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID (clinicaltrials.gov) - P2 | N=114 | Active, not recruiting | Sponsor: Berlin Cures GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Novel Coronavirus Disease

Persistence of autoantibodies directed against the beta-1-adrenoceptor in patients with heart failure after treatment with BC 007 (Rovunaptabin). Results of a phase IIa study. (HEART FAILURE 2024) - No abstract available

Clinical • P2a data • Cardiovascular • Congestive Heart Failure • Heart Failure

BLOC: To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID (clinicaltrials.gov) - P2 | N=114 | Recruiting | Sponsor: Berlin Cures GmbH | Trial completion date: Nov 2024 ➔ May 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Novel Coronavirus Disease

"Kümmern Sie sich um #Impfschäden! Kümmern Sie sich um #Impfnebenwirkungen! Kümmern Sie sich um #PostVac-Betroffene! Kümmern Sie sich um #LongCovid-Betroffene! Kümmern Sie sich um #LongCovidKids! Kümmern Sie sich um #MECFS-Betroffene! Kümmern Sie sich um #BC007 von @BerlinCures!" (@B_A_f_H_)

Novel Coronavirus Disease

"The @EMA_News is not doing anything to accelerate the approval process. Therefore the #BC007 approval will take years!" (@TimoStrotmann)

"I hope so, there must be an emergency approval for bc007 against long covid" (@Aiioo156Aiioo)

Novel Coronavirus Disease

"@Dr_B_Hohberger AAK und bc007 @KraterMartin Blutzellverformung @maidoc im Bezug auf mcas" (@SunnyDayYeah)

BLOC: To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID (clinicaltrials.gov) - P2 | N=114 | Recruiting | Sponsor: Berlin Cures GmbH

New P2 trial • Novel Coronavirus Disease

"Have you looked into the drug bc 007 at all via berlin cures?" (@Bradgolf1216)

"BC 007!" (@CrissieT6)

"Hello, I hope you can pay attention to BC007, a small molecule based on GCPR-aab theory, which really shows great potential for treating longcovid!" (@lingtian888888)

Novel Coronavirus Disease

"@BayerKarriere @BPI_Pharma @BMG_Bund @BMZ_Bund @BMUV @BMBF_Bund @BMFSFJ @DIEZEIT @TAG24 @StZ_NEWS @AstraZeneca @novartis #BC007 #Immunadsorption #HELP #Apherese #IHHT #HBOT #Medikamentenmangel #Medizinbrennt #HILFE #Antiviral #chronicillness #FroheOstern #ableist #BringBackMasks" (@FrauSausNRW)

The Persistence of Autoantibody Neutralisation by BC 007 in Patients With Chronic HFrEF and Autoantibodies Against the Beta1-Adrenergic Receptor (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Berlin Cures GmbH | Active, not recruiting ➔ Completed

Trial completion • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

"Besser wenn wir betroffene selbst Mikroskop kaufen, als auf solche "Forscher" warten.Nach 60Jahren MECFS Gesgcichte und diese Forscher haben viel weniger Ahnung, als die Betroffene...Geben Sie mir diese 22,5 millionen besser verschwende ich auf BC007 als solche "STUDIEN"" (@Kovek88)

"BC007 from @BerlinCures need a push! @Europarl_EN and @EMA_News ist totally incompetent!" (@MartinWirone)

"@BayerKarriere @BPI_Pharma @BMG_Bund @BMZ_Bund @BMUV @BMBF_Bund @BMFSFJ @DIEZEIT @TAG24 @StZ_NEWS @AstraZeneca #BC007 #Immunadsorption #HELP #Aphererese #IHHT #HBOT #Medikamentenmangel #Medizinbrennt #HILFE" (@FrauSausNRW)

"A bit of BC007 might be nice." (@tammbrant)

"🪄Looks like BC007 💕🤩💖✨ Danke für Deine Arbeit, Faraz!!! Das wird eine super Kampagne!" (@A_n_y____)

"„Die @EMA_News und das @bfarm geben Phase 3 Studie für BC007 frei“ „Riesen Erfolg die Discover Studie in Erlangen ist Abgeschlossen und Recover soll eventuell in 2034 starten“ „Longcovid Experte Prof Kleinschnitz tritt für die AFD zur Bundestagswahl an“ Jetzt seid ihr dran!" (@MartinWirone)

P3 data • Novel Coronavirus Disease

"BC007!" (@MaryMitsh)

"Sie empfehlen #bc007 auf Twitter und verhindern seit 1,5 Jahren dessen Zulassung als Minister???? #schwereschuld #postcovid #mecfs Ist das Satire???" (@dornroesche)

Novel Coronavirus Disease