ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer
ESSA Pharma announced the termination of its Phase 2 clinical trial evaluating masofaniten combined with enzalutamide in metastatic castration-resistant prostate cancer patients. The decision came after a futility analysis showed the enzalutamide control arm performing better than historical controls and similar to the combination therapy, making it unlikely to achieve the primary endpoint. All additional clinical studies with masofaniten will be terminated. The company reported $126.8 million in cash reserves and $124.3 million in net working capital as of September 30, 2024. Management will initiate a strategic review process to maximize shareholder value.
ESSA Pharma ha annunciato la chiusura del suo trial clinico di Fase 2 che valutava il masofaniten in combinazione con l'enzalutamide nei pazienti affetti da cancro prostatico metastatico resistente alla castrazione. La decisione è stata presa dopo che un'analisi di inefficacia ha mostrato che il braccio di controllo con enzalutamide ha performato meglio rispetto ai controlli storici e in modo simile alla terapia combinata, rendendo improbabile il raggiungimento dell'obiettivo primario. Tutti gli ulteriori studi clinici con masofaniten saranno interrotti. L'azienda ha riportato 126,8 milioni di dollari in riserve di cassa e 124,3 milioni di dollari in capitale di lavoro netto al 30 settembre 2024. La direzione avvierà un processo di revisione strategica per massimizzare il valore per gli azionisti.
ESSA Pharma anunció la terminación de su ensayo clínico de Fase 2 que evaluaba el masofaniten combinado con enzalutamida en pacientes con cáncer de próstata metastásico resistente a la castración. La decisión se tomó después de que un análisis de ineficacia mostrara que el brazo de control con enzalutamida tenía un rendimiento mejor que los controles históricos y similar a la terapia combinada, lo que hacía improbable alcanzar el objetivo primario. Todos los estudios clínicos adicionales con masofaniten serán finalizados. La compañía reportó 126.8 millones de dólares en reservas de efectivo y 124.3 millones de dólares en capital de trabajo neto al 30 de septiembre de 2024. La dirección iniciará un proceso de revisión estratégica para maximizar el valor para los accionistas.
ESSA Pharma는 전이성 거세 저항성 전립선암 환자를 대상으로 한 엔자루타마이드와 결합된 마소파니텐의 2상 임상 시험 종료를 발표했습니다. 결정은 비효능 분석 결과 엔자루타마이드 대조군이 역사적 대조군보다 더 나은 성과를 보였고, 조합 요법과 비슷하다는 사실에 따라 이루어졌으며, 주요 목표를 달성할 가능성이 낮았음을 나타냅니다. 마소파니텐과 관련된 모든 추가 임상 연구는 종료될 예정입니다. 이 회사는 2024년 9월 30일 기준으로 1억 2,680만 달러의 현금 준비금과 1억 2,430만 달러의 순운전자본을 보고했습니다. 경영진은 주주 가치를 극대화하기 위한 전략적 검토 프로세스를 시작할 것입니다.
ESSA Pharma a annoncé la cessation de son essai clinique de Phase 2 évaluant le masofaniten combiné à l'enzalutamide chez des patients atteints de cancer de la prostate métastatique résistant à la castration. La décision a été prise après qu'une analyse d'inefficacité a montré que le bras de contrôle de l'enzalutamide performait mieux que les contrôles historiques et de manière similaire à la thérapie combinée, rendant peu probable l'atteinte de l'objectif principal. Toutes les études cliniques supplémentaires avec le masofaniten seront interrompues. La société a rapporté 126,8 millions de dollars de réserves de liquidités et 124,3 millions de dollars de fonds de roulement net au 30 septembre 2024. La direction lancera un processus de révision stratégique pour maximiser la valeur pour les actionnaires.
ESSA Pharma hat die Beendigung seiner klinischen Phase-2-Studie bekannt gegeben, die die Kombination von Masofaniten mit Enzalutamid bei Patienten mit metastasierendem, kastrationsresistentem Prostatakrebs bewertet hat. Die Entscheidung wurde nach einer Nutzlosigkeitsanalyse getroffen, die zeigte, dass der Kontrollarm mit Enzalutamid besser abschnitt als historische Kontrollen und ähnlich wie die Kombinationstherapie, sodass es unwahrscheinlich ist, das primäre Ziel zu erreichen. Alle zusätzlichen klinischen Studien mit Masofaniten werden eingestellt. Das Unternehmen berichtete am 30. September 2024 über 126,8 Millionen US-Dollar in Barreserven und 124,3 Millionen US-Dollar an Nettoumlaufvermögen. Das Management wird einen strategischen Überprüfungsprozess einleiten, um den Aktionärswert zu maximieren.
- Strong financial position with $126.8M in cash reserves
- No long-term debt obligations
- Combination therapy showed acceptable safety profile with no new safety signals
- Phase 2 trial termination due to failure to show efficacy advantage
- Termination of all remaining clinical studies with masofaniten
- Drug candidate failed to meet company's target product profile
- Control arm outperformed combination therapy in PSA90 response rate (73% vs 64%)
Insights
The termination of ESSA Pharma's Phase 2 study represents a significant setback for their lead drug candidate masofaniten. The trial's futility analysis revealed that the combination of masofaniten with enzalutamide showed no clear advantage over enzalutamide alone in treating metastatic castration-resistant prostate cancer. The control arm (enzalutamide) performed better than historical data with a
The company's decision to terminate all clinical studies of masofaniten and withdraw regulatory applications signals the end of this development program. With
This development represents a critical blow to ESSA's business model and future prospects. The company's decision to explore strategic options typically signals potential M&A activity, asset sales, or complete restructuring. Their strong cash position of
Efficacy signals observed will not achieve ESSA's target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens
A futility analysis conducted as part of a protocol-specified interim review of the safety, PK and efficacy data showed the single-agent enzalutamide control arm performing better than historical controls and similar to the combination of masofaniten and enzalutamide and therefore, unlikely to achieve the primary endpoint of the study
Additional clinical studies with masofaniten including the combination study with abiraterone acetate and apalutamide as well as the remaining investigator sponsored trials will also be terminated and the IND and CTAs in different geographies will be withdrawn
Company will initiate a process to explore and review strategic options focused on maximizing shareholder value
"Providing a meaningful clinical benefit to patients in our clinical trials, along with a robust safety profile, is of utmost importance to us at ESSA," said David Parkinson, MD, President and CEO. "We designed this randomized study to rigorously evaluate the clinical benefit of adding masofaniten to enzalutamide. We made the difficult decision to terminate this Phase 2 study following the interim analysis because we concluded that the emerging efficacy profile of masofaniten combined with enzalutamide would not likely meet the primary endpoint of the study, nor our internal requirements for a prostate cancer therapy candidate. We would like to thank our partners, investigators, employees, and most importantly, the patients and their families involved in our clinical trials."
Richard Glickman, LLD, Chairman of the Board of Directors of ESSA, commented, "Senior management, together with the board of directors, are actively focused on preserving capital and will initiate a strategic process to explore and review a range of strategic options focused on maximizing shareholder value."
The Phase 2 study (NCT05075577) was designed as an open label, two-arm randomized (2:1) trial and was planned to enroll a total of 120 patients (80 in the combination arm and 40 in the enzalutamide single agent arm). The efficacy interim analysis included 52 enrolled patients (
Primary and PSA-related Secondary Endpoints of the Study
Primary | Secondary | Secondary | Secondary | |
Phase 2 Study Arm | PSA90 response rate* | PSA50 response rate* | PSA50 @ 90 days response rate | PSA90 @ 90 days response rate |
Enzalutamide 160mg QD | 73 % | 87 % | 86 % | 71 % |
Masofaniten 600mg BID + enzalutamide 160mg QD | 64 % | 88 % | 93 % | 67 % |
*The PSA90 response rate was calculated in patients completing at least 1 month of treatment |
As part of the effort to focus its resources, ESSA is also planning to terminate the other remaining company-sponsored and investigator-sponsored clinical studies evaluating masofaniten either as a monotherapy or in combination with other agents.
Liquidity and Outstanding Share Capital
- As of September 30, 2024, the Company had available cash reserves and short-term investments of
$126.8 million $124.3 million - As of September 30, 2024, the Company had 44,388,551 common shares issued and outstanding, and there were 2,920,000 common shares issuable upon the exercise of prefunded warrants at an exercise price of
$0.00 01
About the Phase 2 Study
The Phase 2 dose expansion portion of this Phase 1/2 study is a two-arm, randomized, open-label study (NCT05075577) that evaluated the safety, tolerability and preliminary efficacy of masofaniten, and was expected to enroll approximately 120 patients. Criteria for entry into the Phase 2 dose expansion were similar to those in the Phase 1 dose escalation. Patients continued to receive androgen deprivation therapy and were randomized 2:1 to receive either the combination of masofaniten (600mg twice-daily ("BID")) and enzalutamide (160mg once daily ("QD")) or enzalutamide (160mg QD) as a single agent. Patients were eligible to remain on study treatment as long as they tolerated treatment without disease progression based on RECIST v1.1 and/or Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.
About Masofaniten
Masofaniten (formerly known as EPI-7386) is a first-in-class investigational oral, small molecule inhibitor of the androgen receptor ("AR"). Masofaniten's unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth. The
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit www.essapharma.com, and follow us on X and LinkedIn.
Forward-Looking Statement Disclaimer
This release contains certain information which, as presented, constitutes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements include, but are not limited to, statements that relate to future events and often addresses expected future business and financial performance, containing words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding the termination of the Company's clinical studies of masofaniten, the Company's financial resources, the evaluation of the Company's strategic alternatives, the primary and PSA-related endpoints of the Phase 2 study and other statements surrounding the Company's evaluation of masofaniten.
Forward-looking statements are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA's actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA's current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward looking statements, ESSA may make various material assumptions, including but not limited to (i) the accuracy of ESSA's financial projections; (ii) obtaining positive results of clinical trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market and economic conditions.
Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors set out herein and in ESSA's Annual Report on Form 10-K dated December 12, 2023, under the heading "Risk Factors", a copy of which is available on ESSA's profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca, and as otherwise disclosed from time to time on ESSA's EDGAR and SEDAR+ profiles. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable
Contacts
ESSA Pharma, Inc.
Peter Virsik, Chief Operating Officer
778.331.0962
pvirsik@essapharma.com
Investors and Media:
Argot Partners
212.600.1902
essa@argotpartners.com
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