MITO Empowered, FPRX Cuts Another 70 Jobs, Second Death In Legionnaires Outbreak

pharma 042017 11oct19

Today's Daily Dose brings you news about Stealth BioTherapeutics' agreement with Alexion; Aclaris' divestiture of RHOFADE cream 1%; Aerpio Pharma's interim results from phase 1b trial of AKB-9778; workforce reduction in Five Prime, and the latest update on NC Mountain State Fair Legionnaires disease outbreak.

Read on…

Shares of Stealth BioTherapeutics Corp (MITO) jumped more than 11% on Thursday, following an agreement for an option to co-develop and commercialize Elamipretide for mitochondrial diseases with Alexion Pharmaceuticals Inc. (ALXN).

Stealth BioTherapeutics' Elamipretide is under:

-- a phase III trial for the treatment of primary mitochondrial myopathy, a genetic mitochondrial disease, dubbed MMPOWER-3
-- a phase II/III clinical trial for the treatment of Barth, dubbed TAZPOWER
-- a phase II trial for the treatment of Leber's Hereditary Optic Neuropathy, dubbed RESIGHT
-- a phase II study in subjects with dry AMD with geographic atrophy, dubbed RECLAIM-2

Under the terms of the agreement, Alexion will have the opportunity to exercise the option following the delivery of results from the phase III study currently underway in primary mitochondrial myopathy.

If the option is exercised, Alexion and Stealth will co-develop and co-promote subcutaneous Elamipretide in the U.S., and Alexion will receive an exclusive ex-U.S. license.

The agreement entitles Stealth to receive initial payment of $30 million for equity investment, option fee and development funding, with potential for additional option-related and milestone-dependent payments if the option is exercised.

MITO closed Thursday's trading at $7.10, up 11.81%.

As part of its recently announced strategic plan to refocus resources on the development of immuno-inflammatory assets, Aclaris Therapeutics Inc. (ACRS) has divested RHOFADE cream 1% and related intellectual property assets to EPI Health, LLC.

RHOFADE cream, 1% is an FDA-approved prescription treatment that is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
RHOFADE was approved in the U.S. in January 2017. Aclaris acquired the worldwide rights to RHOFADE cream, 1% from Allergan Sales, LLC. last November.

Aclaris stands to earn total cash consideration of up to $55.0 million from EPI Health, including an upfront payment of $35.0 million and potential sales milestone payments of up to $20.0 million upon the achievement of specified levels of net sales of products covered by the agreement.

In addition, EPI Health has agreed to pay Aclaris, a specified high single-digit royalty calculated as a percentage of net sales, on a product-by-product and country-by-country basis, subject to specified reductions, limitations and adjustments and 25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health from a licensee or sublicensee in any territory outside of the United States.

ACRS closed Thursday's trading at $1.19, up 2.59%.

The Week 52 data from Gilead Sciences Inc. (GILD) and Galapagos NV's (GLPG) phase III trials of Filgotinib for the treatment of moderately-to-severely active rheumatoid arthritis, dubbed FINCH 1 and FINCH 3, are found to be consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier this year.

Filgotinib for the treatment of adults with rheumatoid arthritis is now under review by the European Medicines Agency, and a New Drug Application for the compound has been submitted to the Japanese Ministry of Health, Labor and Welfare.

Gilead plans to file a New Drug Application for Filgotinib for the treatment of rheumatoid arthritis in the United States including the FINCH 1 and FINCH 3 Week 52 data later this year.

GLPG closed Thursday's trading at $157.49, up 1.46%.

The AIDS Healthcare Foundation is all set to open a new health care center delivering state-of-the-art HIV/AIDS medical care and services to patients regardless of their insurance status or ability to pay, in Bronx, New York, on October 11, 2019.

Five Prime Therapeutics Inc. (FPRX) is slashing its headcount by approximately 70 positions across all functions as part of a corporate restructuring to extend the company's cash runway without impacting or delaying the data timelines of its clinical programs.

According to the Company, seventy percent of job cuts will be implemented by the end of 2019, with the remainder occurring in 2020.

The restructuring, planned facility expense reduction and other cost-saving efforts will result in approximately $20 million in annualized cost savings, cash, cash equivalents and marketable securities at year-end expected to be in the range of $148 to $153 million.

Last month, Aron Knickerbocker resigned as the Company CEO, and William "Bill" Ringo was appointed as Interim Chief Executive Officer. In January of this year, the Company had laid off 41 employees.

Pipeline & Near-term Catalysts:

-- A phase III global registrational trial of Bemarituzumab in gastric and gastroesophageal junction, dubbed FIGHT, is underway. An early futility analysis for the FIGHT trial is expected to be conducted during the first half of 2020. The purpose of the futility analysis is to ensure the trial is adequately powered to detect an overall survival benefit at full enrollment.
-- A phase II clinical trial evaluating Cabiralizumab and Bristol-Myers Squibb Co.'s (BMS) OPDIVO in patients with advanced pancreatic cancer is ongoing.
-- A Phase 1a/1b trial of FPA150 in patients with advanced solid tumors is underway. The preliminary efficacy results from the Phase 1b monotherapy expansion portion of the study in patients preselected for B7-H4 tumor overexpression across breast, endometrial and ovarian cancers, and early safety results from the Phase 1a Keytruda combination portion of the study in patients preselected for B7-H4 tumor overexpression in ovarian cancer presented on September 30, 2019, were promising.
-- A Phase 1a/1b trial of FPT155 for the treatment of solid tumors is underway.

FPRX closed Thursday's trading at $4.24, down 2.30%.

Aerpio Pharmaceuticals Inc. (ARPO) has announced interim results from its Phase 1b clinical trial of a topical ocular formulation of AKB-9778 as a potential treatment for primary open-angle glaucoma.

The ongoing phase 1b study included 4 sequential cohorts of 12 subjects, randomized 3:1 to receive AKB-9778 dosed topically as eye drops in dosages of 5mg/ml QD, 15 mg/ml QD, 40 mg/ml QD and 40 mg/ml BID, or placebo, for 7 days.

The interim analysis was limited to the first three cohorts (5 mg/ml QD, 15 mg/ml QD, 40 mg/ml QD). AKB-9778 has been found to be well tolerated over 7 days at all dose levels for the first three cohorts. Compared to placebo, there was a dose-dependent increase in minimal to mild conjunctival hyperemia with AKB-9778, which was transient and generally considered non-adverse, according to the Company.

The Company also noted that there was a time and dose-dependent reduction in intraocular pressure. Elevated pressure in the eye is one of the risk factors for glaucoma.

The full results of the ongoing Phase 1b study are expected to be reported in the first quarter of 2020.

ARPO closed Thursday's trading at $0.59, down 2.63%.

The investigation into the Legionnaire's disease outbreak associated with the NC Mountain State Fair has revealed that as of Oct. 9, there have been 134 cases of Legionnaires' disease or Pontiac Fever, a type of pneumonia, in residents of multiple states and North Carolina counties who attended the 2019 NC Mountain State Fair.

Eighty-eight people have been hospitalized and two deaths have been reported.

The 2019 NC Mountain State Fair took place between September 6 and September 15, 2019, at the Western North Carolina Agricultural Center in Fletcher, NC.

According to the investigators, exposure to Legionella bacteria occurred in the Davis Event Center of the WNC Ag Center, particularly near the hot tubs and during the last five days of the fair.

Hot tubs (or spas) that are not cleaned and disinfected enough can become contaminated with Legionella, the bacteria that causes Legionnaires' disease. A person can get infected with Legionella when they breathe in steam or mist from a contaminated hot tub. (Source: CDC).

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