Phase I Clinical Trial for Investigational Prostate Drug Called EPI-7386 Planned 2020

Dec 30, 2019 | IND, Oncology, Phase I Clinical Trials, Prostate Cancer

Phase I Clinical Trial for Investigational Prostate Drug Called EPI-7386 Planned 2020

An emerging biotech called ESSA Pharma Inc. (EPIX) is developing treatments for prostate cancer that is no longer responding to current therapies. The venture is developing a series of compounds (antigens) that disrupt the androgen receptor (AR) signaling pathway via a novel mechanisms of action targeting the N-terminal domain (NTD) of the AR, as opposed to the ligand-binding domain (LBD) of the AR that is targeted by all other AR-directed prostate cancer treatments. A lead preclinical antigen called EPI-7386 has been selected to advance to clinical trials and the sponsor hopes to file an IND by the first quarter 2020.

Background

The company had previously tested a first-generation antigen compound called EPI—002 in a Phase I clinical trial in patients with mCRPC that were progressing after abiraterone or enzalutamide with serially rising PSAs. While EPI-002 was shown to be safe and well tolerated, the compound exhibited a short half-life and minimal therapeutic exposure that led to suboptimal results. Consequently, ESSA decided to invest in a new discovery effort to develop next-generation antien’s.

EPI-7386

Following the synthesis of >300 compounds, the venture identified EPI-7386 as the lead IND candidate due to it possessing a number of positive attributes compared to EPI-002, which included:

·         Increased potency

·         Reduced in vitro metabolism

·         Activity against AR-V7 in vitro models

·         Similar activity to enzalutamide in LNCaP xenograft models

·         Enhanced activity in VCaP xenograft model

Forthcoming Phase I Clinical Trial of EPI-7386 in Q1 2020

The company will soon file an IND for EPI-7386 in Q 2020 and a Phase I clinical trial initiated soon thereafter in patients who are resistant to second-generation anti-androgen therapies (E.g. enzalutamide). The trial will include both a dose escalation phase and a dose expansion phase. The primary objective of the dose escalation portion is to establish the safety and efficacy of EPI-7386 with a secondary objective being to determine the maximum tolerated dose and recommended Phase II dose. In addition to a Phase II dose expansion, the company will plan to initiate a combination trial with EPI-7386 and a ‘lutamide’ (enzalutamide, apalutamide, or darolutamide) in mCRPC patients due to robust preclinical data evidencing increased activity with combination therapy.

Essa Pharmaceutical Profile

Vancouver, BC-based EPIX was founded in 2009 and is now publicly traded at $5.50 per share and a market capitalization of $110 million.

Financials

The company positions that it has the necessary financing to conduct the three clinical trials. Their most recent financial results for end of fiscal year are linked here.

0 Comments

Pin It on Pinterest