A single-center, open-label, fixed-sequence Phase 1 trial to evaluate the effect of multiple doses of pritelivir on the pharmacokinetics of substrates for CYP2C9, CYP2B6, CYP3A4 and OATP2B1 - Pritelivir DDI study with celiprolol, flurbiprofen, bupropion and midazolam

Start Date18 Oct 2021

Sponsor / Collaborator

Aicuris Anti-Infective Cures AG

NL-OMON50254 / CompletedNot Applicable

A single center, open-label Phase 1 trial to evaluate the mass balance and metabolite profile of a single oral dose of pritelivir. - Mass balance and metabolite profile of pritelivir.

Start Date05 Oct 2021

Sponsor / Collaborator

Aicuris Anti-Infective Cures AG

NCT05513625 / CompletedPhase 1

A Single-center, Open-label, 2-period Fixed-sequence Phase I Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Pritelivir

To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV.

Start Date13 Jul 2020

Sponsor / Collaborator

Aicuris Anti-Infective Cures AG

100 Clinical Results associated with Pritelivir

100 Translational Medicine associated with Pritelivir

100 Patents (Medical) associated with Pritelivir

Literatures (Medical) associated with Pritelivir

01 Jul 2023·Clinical pharmacology in drug development

First‐in‐Human, Single‐ and Multiple‐Ascending‐Dose, Food‐Effect, and Absolute Bioavailability Trials to Assess the Pharmacokinetics, Safety, and Tolerability of Pritelivir, a Nonnucleoside Helicase‐Primase Inhibitor Against Herpes Simplex Virus in Healthy Subjects

Article

Author: Sumner, Melanie ; Rübsamen-Schaeff, Helga ; von Richter, Oliver ; Zimmermann, Holger ; Bonsmann, Susanne ; Birkmann, Alexander ; Pausch, Jörg ; McCormick, David ; Kropeit, Dirk

Abstract:

The pharmacokinetics and safety of the novel herpes simplex virus helicase‐primase inhibitor pritelivir were evaluated in 5 phase 1 trials: a single‐ascending‐dose trial, 2 multiple‐ascending‐dose trials, a food‐effect trial, and an absolute bioavailability trial in healthy male subjects. One cohort of healthy female subjects was included in the single‐ascending‐dose trial. Pritelivir pharmacokinetics were linear up to 480 mg following single and up to 400 mg following multiple once‐daily doses. The half‐life ranged from 52 to 83 hours, and steady state was reached between 8 and 13 days. Maximum plasma concentration and area under the plasma concentration–time curve from time 0 to the last quantifiable concentration were 1.5‐ and 1.1‐fold higher in female compared to male subjects. Absolute bioavailability was 72% under fasted conditions. Following a fatty diet, pritelivir time to maximum concentration was 1.5 hour delayed and maximum plasma concentration and area under the plasma concentration–time curve from time 0 to the last quantifiable concentration were 33% and 16% higher, respectively. Pritelivir was safe and well tolerated up to 600 mg following single and up to 200 mg following multiple once‐daily doses. Considering a therapeutic dose of 100 mg once‐daily, pritelivir demonstrated a favorable safety and tolerability and pharmacokinetic profile in healthy subjects to support further development.

17 May 2023·Antimicrobial agents and chemotherapy

Case Commentary: "Salvage Treatment of Refractory HSV Oral Lesions with Pritelivir in Allogeneic Hematopoietic Cell Transplant Recipients" by Bosetti et al.

Article

Author: Ho, Dora Y ; Srinivasan, Krithika

18 Apr 2023·Antimicrobial agents and chemotherapy

Salvage Treatment of Refractory HSV Oral Lesions with Pritelivir in Allogeneic Hematopoietic Cell Transplant Recipients.

Article

Author: Maulini, Marie ; Neofytos, Dionysios ; Mamez, Anne-Claire ; Bosetti, Davide ; Bernardi, Chiara ; Masouridi-Levrat, Stavroula ; Giannotti, Federica ; Chalandon, Yves

We present two allogeneic hematopoietic cell transplantation recipients (HCTr) treated with pritelivir for acyclovir-resistant/refractory (r/r) HSV infection based on the expanded access program of the pritelivir manufacturer. Outpatient treatment with pritelivir was administered, with partial response by week 1 of treatment and complete response by week 4 of treatment in both patients. No adverse events were noted. Pritelivir appears to be an effective and safe option for the management of acyclovir-r/r HSV infections in highly immunocompromised patients in an outpatient setting.

News (Medical) associated with Pritelivir

09 Jan 2024

·www.biospace.com

AiCuris Received 15 Million Euros Milestone Payment from Licensing Partner MSD Following EMA Approval of PREVYMIS(R) for Prevention of CMV Infection in High-Risk Adult Kidney Transplant Recipients

PREVYMIS® now approved in the U.S. and Europe for prophylaxis of Cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R‑]) EMA approval triggers a €15 Million Milestone payment to AiCuris and AiCuris is eligible for further milestone payments and royalties on future net sales Obtained funds will further boost the clinical development of AiCuris' product candidate Pritelivir for treatment of resistant herpes simplex virus (HSV) infections in immunocompromised patients WUPPERTAL, GERMANY / ACCESSWIRE / January 9, 2024 / AiCuris Anti-infective Cures AG, a leading clinical-stage pharmaceutical company developing novel, therapeutic candidates for the prevention and treatment of severe and potentially life-threatening infectious diseases in immunocompromised patients, announced today that it has received milestone payments in the amount of EUR €15 million from its licensing partner MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA, (MRK)) following EMA approval for the first-in-class antiviral agent PREVYMIS® (letermovir) for the prophylaxis of CMV disease after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients at high risk. "Following the U.S. approval mid-2023, we are excited that our partner MSD now also received European approval for PREVYMIS® (letermovir) in its second indication, the prophylaxis of CMV infection in adult kidney transplanted patients at high risk. This is a further important step to broadly make this drug available to immunocompromised patients being in high need of a novel, safe and effective treatment option against CMV infection and disease," said Larry Edwards, CEO of AiCuris Anti-infective Cures AG. "We are proud to watch the continued success story of letermovir and aim to leverage our comprehensive research and development engine to deliver further novel therapeutic options to immunocompromised patients with high medial need." PREVYMIS® (letermovir) is an antiviral agent that was initially approved by the U.S. Food and Drug Administration (FDA) in 2017 and by the EMA in 2018 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic HSCT. In June 2023, the FDA and in December 2023 the EMA approved PREVYMIS® for prophylaxis of CMV disease in adult kidney transplant recipients at high risk. Moreover, extended 200-day dosing for PREVYMIS® for CMV prophylaxis in adult HSCT recipients at risk for late CMV infection and disease was approved by the FDA in August 2023. Approvals by national authorities was supported by a Phase 3, randomized, multicenter, double-blind, active comparator-controlled non-inferiority trial (P002, NCT03443869) in 589 adult kidney transplant recipients at high risk (CMV D+/R-). According to the MSD announcement, the study demonstrated that PREVYMIS® was non-inferior to valganciclovir, the current standard of care, for the primary endpoint of incidence of CMV disease (CMV end-organ disease or CMV syndrome, confirmed by an independent adjudication committee) through Week 52 post-kidney transplant. About AiCuris Anti-infective Cures AG AiCuris aims to discover, develop, and deliver innovative, anti-viral drugs to immunocompromised patients aiming to prevent severe condition and life-threatening diseases. The company has developed a commercial drug as well as pipeline of clinical-stage and pre-clinical anti-viral candidates. Its lead product PREVYMIS® (letermovir), a first-in-class non-nucleoside cytomegalovirus (CMV) inhibitor, was licensed to MSD and is commercialized for the prevention of human CMV infections in immunocompromised patients who underwent an allogeneic hematopoietic stem cell transplantation or kidney transplantation. AiCuris' wholly owned product candidate, Pritelivir, targeting resistant herpes simplex virus (HSV) infections in immunocompromised patients, is in phase 3 clinical development. Therapeutic candidates for the treatment of other virus infections such as BK virus and adenovirus are in earlier stages of development. AiCuris is supported by a strong shareholder base, including lead investor SANTO Holding. For more information, please visit . Follow us on LinkedIn. Contacts: Company: AiCuris Anti-infective Cures AG Dr. Katharina Nothelfer Phone: +49 202 317 63 0 Email: press@aicuris.com Media relations MC Services AG Dr. Solveigh Mähler Phone: +49 211 529 252 19 Email: aicuris@mc-services.eu SOURCE: AiCuris Anti-infective Cures AG View the original press release on accesswire.com

Phase 3Drug ApprovalLicense out/inImmunotherapyClinical Result

23 Aug 2023

·www.biospace.com

AiCuris Received 30 Million Euros Milestone Payment from Licensing Partner MSD Following U.S. FDA Approval of PREVYMIS(R) (letermovir) in Second Indication

PREVYMIS ® now approved for prophylaxis of Cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R‑]) This first-in-class antiviral agent was initially approved by FDA for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT) AiCuris received Euro €30 Million milestone payment and additionally is eligible for additional milestone payments and royalties on future net sales WUPPERTAL, GERMANY / ACCESSWIRE / August 23, 2023 / AiCuris Anti-infective Cures AG, a leading clinical-stage pharmaceutical company developing novel, therapeutic candidates for the prevention and treatment of severe and potentially life-threatening infectious diseases in immunocompromised patients, announced today that it has received milestone payments in the amount of EUR €30 million from its licensing partner MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA, (MRK)) following U.S. Food and Drug Administration (FDA) approval for first-in-class antiviral agent PREVYMIS ® in a new indication - the prophylaxis of CMV disease after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients. "We are excited that our partner MSD received FDA approval for PREVYMIS® (letermovir) for the prophylaxis of CMV infection in kidney transplanted patients. Since 2017, the drug has already protected thousands of allogeneic stem cell transplanted patients from CMV disease. With this label expansion, CMV-seropositive kidney transplant patients now have a novel, safe and effective treatment option," said Larry Edwards, CEO of AiCuris Anti-infective Cures AG . "This important milestone further validates our comprehensive research and development engine and supports the development of our pipeline including our proprietary phase 3 product candidate, Pritelivir, developed for treatment of resistant herpes simplex virus (HSV) infections in immunocompromised patients." The FDA approval was supported by a Phase 3, randomized, multicenter, double-blind, active comparator-controlled non-inferiority trial (P002, NCT03443869) in 589 adult kidney transplant recipients at high risk (CMV D+/R-). According to the MSD announcement, the study demonstrated that PREVYMIS ® was non-inferior to valganciclovir, the current standard of care, for the primary endpoint of incidence of CMV disease (CMV end-organ disease or CMV syndrome, confirmed by an independent adjudication committee) through Week 52 post-kidney transplant. For more detailed information on the Phase 3 trial, please follow the link to the corresponding press release recently published by U.S. Merck &Co., Inc. About AiCuris Anti-infective Cures AG AiCuris aims to discover, develop, and deliver innovative, anti-viral drugs to immunocompromised patients aiming to prevent severe condition and life-threatening diseases. The company has developed a commercial drug as well as pipeline of clinical-stage and pre-clinical anti-viral candidates. Its lead product PREVYMIS® (letermovir), a first-in-class non-nucleoside cytomegalovirus (CMV) inhibitor, was licensed to MSD and is commercialized for the prevention of human CMV infections in immunocompromised patients who underwent an allogeneic hematopoietic stem cell transplantation or kidney transplantation. AiCuris' wholly owned product candidate, Pritelivir, targeting resistant herpes simplex virus (HSV) infections in immunocompromised patients, is in phase 3 clinical development. Therapeutic candidates for the treatment of other virus infections such as BK virus and adenovirus are in earlier stages of development. AiCuris is supported by a strong shareholder base, including lead investor SANTO Holding. For more information, please visit . Follow us on LinkedIn. Contacts: Company: AiCuris Anti-infective Cures AG Dr. Katharina Nothelfer Phone: +49 202 317 63 0 Email: press@aicuris.com Media relations MC Services AG Dr. Solveigh Mähler Phone: +49 211 529 252 19 Email: aicuris@mc-services.eu SOURCE: AiCuris Anti-infective Cures AG View source version on accesswire.com:

Phase 3Drug ApprovalLicense out/inClinical ResultImmunotherapy

06 Jul 2023

·www.fiercebiotech.com

AiCuris 'sharpens strategic focus' to immune-compromised at expense of other programs

Heading up AiCuris’ refocused pipeline will be Pritelivir, which is in phase 3 development to treat acyclovir-resistant herpes simplex virus infections. AiCuris is doubling down on its infectious disease pipeline at the expense of its COVID-19 and foot infection programs. “Sharpening its strategic focus” on a portfolio of therapies for infectious diseases in immunocompromised patients means the biotech will be able to accelerate development plans and prepare for market launch, the Wuppertal, Germany-based company said in a July 6 release. The knock-on effect is that AiCuris “will discontinue research activities outside of this strategic scope.” While the company didn’t go into details of what activities will be scrapped, the COVID-19 therapy AIC649 was notable for its absence from today’s release. The company received 5.9 million EUR ($6.4 million) in funding from a regional German government last year to advance the immune modulator as a potential way to slow progression of COVID-19. The therapy had been undergoing a clinical study in Germany and Africa. Another program that wasn’t name-checked today was AiCuris’ collaboration with fellow German biotech Lysando. The two companies were working on Artilysin, a potential treatment for infected, chronic wounds such as diabetic foot infections. “Unfortunately, anti-infective treatment options for this growing patient population are often limited and few companies are focusing on developing appropriate therapeutic candidates,” AiCuris CEO Larry Edwards said in the release. “This strategic change will allow us to be more efficient and effective from an operations perspective and ensure we are able to bring novel treatment options to patients in need.” Heading up AiCuris’ refocused pipeline will be Pritelivir, which is in phase 3 development to treat acyclovir-resistant herpes simplex virus infections in immunocompromised patients. Topline data is due at the end of 2024. Then there’s AIC468, an anti-sense RNA therapy due to enter the clinic early next year to prevent BK virus infection in kidney transplanted patients. The biotech is also working on preclinical programs designed to combat human adenovirus infections, with a key goal being to develop the first topical treatment specifically designed for ADV infections of the eye.

Phase 3

100 Deals associated with Pritelivir

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Herpes Simplex	Phase 3	US	Aicuris Anti-Infective Cures AG	08 May 2017
Herpes Simplex	Phase 3	AR	Aicuris Anti-Infective Cures AG	08 May 2017
Herpes Simplex	Phase 3	AU	Aicuris Anti-Infective Cures AG	08 May 2017
Herpes Simplex	Phase 3	BE	Aicuris Anti-Infective Cures AG	08 May 2017
Herpes Simplex	Phase 3	CA	Aicuris Anti-Infective Cures AG	08 May 2017
Herpes Simplex	Phase 3	FR	Aicuris Anti-Infective Cures AG	08 May 2017
Herpes Simplex	Phase 3	GE	Aicuris Anti-Infective Cures AG	08 May 2017
Herpes Simplex	Phase 3	DE	Aicuris Anti-Infective Cures AG	08 May 2017
Herpes Simplex	Phase 3	GR	Aicuris Anti-Infective Cures AG	08 May 2017
Herpes Simplex	Phase 3	IL	Aicuris Anti-Infective Cures AG	08 May 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05513625 (CTgov)	Phase 1	Herpes Simplex	16	Pritelivir (100 mg Pritelivir)	fepdlmyzor(ymjmfmyygc) = zfnrpythnp wpqsmenvxw (eofrdwepdx, dnsiancnwr - nfabhkqrmw) View more	-	15 Sep 2023
				pritelivir+ESO (40 mg qd ESO and 100 mg Pritelivir)	fepdlmyzor(ymjmfmyygc) = gsszxzfmdq wpqsmenvxw (eofrdwepdx, syrqfacwwp - nyqwnexzeq) View more
NCT01047540 (CTgov)	Phase 2	Herpes Genitalis	156	AIC316 (Dose Regimen 1)	qandspupiq(daygxthqgw) = uhgoyvigrc nagasbdncy (qubxtvepdy, pcvxlajxyb - tujhaqlaua) View more	-	04 Feb 2022
				AIC316 (Dose Regimen 2)	qandspupiq(daygxthqgw) = ekojpqyyav nagasbdncy (qubxtvepdy, pwdzekoxmc - npsqpozgyn) View more
NCT02871492 (LipP1, CTgov)	Phase 2	Herpes Labialis	362	Pritelivir 5% w/w ointment (Pritelivir 5% w/w Ointment)	zqjpkixoks(csgojonhzf) = lvzhijokan apdrhipzgg (wqukhsesno, rfugnxlqty - benmyubulu) View more	-	13 Jul 2021
				Pritelivir ointment matching placebo (Pritelivir Ointment Matching Placebo)	zqjpkixoks(csgojonhzf) = gvgzqlovss apdrhipzgg (wqukhsesno, pduutjxndi - mllmtqfjqz) View more
NCT01658826 (Pubmed \| JAMA) Manual	Phase 2	Herpes Simplex	91	Pritelivir	zwjholdpcj(hlershxjvq) = vnectfsfgf ynwkroysis (fakauxsnwh ) View more	Positive	20 Dec 2016
				valacyclovir	zwjholdpcj(hlershxjvq) = uyrdswizrm ynwkroysis (fakauxsnwh ) View more
NCT01047540 (Pubmed \| Br Dent J)	Phase 2	Herpes Simplex	156	Pritelivir 5 mg daily	auqmzlhwqa(kelylmdatk) = bsnntnviiw caxofzvnuf (lgxbikwxjg )	-	16 Jan 2014
				Pritelivir 25 mg daily	auqmzlhwqa(kelylmdatk) = myrusdhayj caxofzvnuf (lgxbikwxjg )

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