Clinical-stage biopharmaceutical company Milestone Pharmaceuticals Inc. (MIST:NASDAQ), which concentrates its efforts on developing and commercializing medicines to treat episodic cardiovascular conditions, today provided "a clinical and regulatory update for its pivotal program with etripamil following recent interactions with the U.S. Food and Drug Administration (FDA)." The company noted that its novel investigational Etripamil nasal spray is a short-acting calcium channel blocker for paroxysmal supraventricular tachycardia (PSVT) patients.
The company's President and CEO Joseph Oliveto commented, "We are pleased with the outcome of our recent interactions with the FDA, as they outline an efficient path to registration for etripamil which eliminates the need to start a new Phase 3 study...The FDA agreed with our plan to modify the ongoing NODE-301B study, now known as the RAPID study, to highlight the unique pharmacology of etripamil, including a primary endpoint of time to conversion within 30 minutes. This study, together with our recently completed NODE-301 study, which will also now use a 30 minute endpoint, will serve to fulfill the efficacy requirements for a New Drug Application (NDA) for etripamil in PSVT."
"In addition to expanding the RAPID study, the modified design will direct patients to administer an additional dose of study drug 10 minutes after the first dose if they still experience signs and symptoms of a supraventricular tachycardia (SVT) episode. We believe this dosing regimen provides a tailored approach to increase efficacy in patients with more persistent events and improve the overall clinical utility of etripamil. We look forward to reopening enrollment in the RAPID study later this year, with results anticipated in late 2021/early 2022," Oliveto added.
The company also separately announced today that "it has entered into a securities purchase agreement with existing shareholder RTW Investments LP for a $25 million private placement." The firm advised that it plans to utilize the net proceeds from the private placement along with its existing cash balances and reserves to fund its currently planned operations into Q2/22.
Milestone further detailed that "it is selling pre-funded warrants to acquire an aggregate 6,655,131 common shares for aggregate gross proceeds of $25 million, or a purchase price of $3.7465 per pre-funded warrant and that each pre-funded warrant is exercisable for one of the company's common shares at an exercise price of $0.01 per share." The company stated that the warrants are immediately exercisable and are not subject to any expiration date, but are subject to certain beneficial ownership limitations.
The company additionally supplied information from its clinical programs and stated that "the FDA indicated that two studies, the RAPID study and the completed NODE-301 study, could fulfill the efficacy requirement for the Company's NDA for etripamil in patients with PSVT." The firm advised that it expects to reopen enrollment in the RAPID study later this year.
The company explained that "PSVT is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning." SVT episodes are quite severe and often present symptoms including heart palpitations, chest pain, shortness of breath, fatigue, lightheadedness, anxiety and several other symptoms. Current standard of care treatment for SVT requires intravenous treatment under direct medical supervision that typically takes place in an emergency department or acute care setting.
The firm stated that its lead investigational product, etripamil, is a novel calcium channel blocker designed and developed to serve as a rapid response treatment for episodic cardiovascular conditions. The product is a nasal spray that can be self-administered by the patient at-home without traveling to an acute care location.
The firm advised that it is presently conducting a comprehensive Phase 3 development program for etripamil for PVT and also plans to begin a Phase 2 proof-of-concept trial in atrial fibrillation patients with rapid ventricular rates.
Milestone Pharmaceuticals is Quebec-based clinical-stage biopharmaceutical company focused on the development and commercialization of cardiovascular medicines. The firm is engaged in developing treatments for use outside of the emergency room or hospital setting for patients suffering from PSVT and other episodic cardiovascular conditions, including atrial fibrillation and angina. Milestone operates in both the U.S. and Canada.
Milestone started off the day with a market capitalization of around $82.2 million with approximately 24.61 million shares outstanding and a short interest of about 5.4%. MIST shares opened greater than 130% higher today at $7.76 (+$4.42, +132.34%) over yesterday's $3.34 closing price. The stock has traded today on extremely high relative volume today between $6.45 and $9.99 per share and is currently trading at $8.72 (+$5.38, +161.08%).[NLINSERT]
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