AEZS Makes Second Try For Macrilen, IPCI To Face FDA Panel, PTCT On Watch

(RTTNews) - Today's Daily Dose brings you news about Intellipharmaceutics' upcoming regulatory catalyst; SteadyMed's progress with lead drug product candidate, Trevyent; Theratechnologies' new antiretroviral treatment in the making; Aeterna's second try for growth hormone drug Macrilen, and preliminary clinical data from Part 1 of a phase II trial of PTC Therapeutics' RG7916 in spinal muscular atrophy.

Read on...

Aeterna Zentaris Inc. (AEZS) (AEZS.TO) has resubmitted a new drug application to the FDA, seeking approval of Macrilen for the evaluation of growth hormone deficiency in adults.

Macrilen was turned down by the regulatory agency in November 2014 due to failed primary analysis and data deficiencies.

Commenting on the resubmission, Richard Sachse, the Company's Chief Scientific Officer, stated, "We believe that the FDA review period of our NDA will be up to six months, setting the stage for potential approval of the product late in 2017 or early in 2018. If the product is approved, it will be the only FDA-approved drug for assessing AGHD."

AEZS closed Friday's trading at $1.00, up 3.09%.

Intellipharmaceutics International Inc.'s (IPCI) (IPCI.TO) New Drug Application for Rexista is scheduled to be reviewed by an FDA panel on July 26, 2017.

The Company is seeking approval of Rexista, an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride, for the relief of pain.

The FDA's final decision on Rexista is set for September 25, 2017.

If approved, Rexista may be the only abuse-deterrent oxycodone product with properties that may provide early warning of drug abuse if the product is manipulated or abused, according to the Company.

IPCI closed Friday's trading at $2.09, down 0.48%.

PTC Therapeutics Inc. (PTCT), on Saturday, presented promising preliminary clinical data from Part 1 of a phase II trial of RG7916 in spinal muscular atrophy, dubbed SUNFISH, confirming that the drug candidate targets the underlying cause of the disease.

Spinal muscular atrophy, or SMA, is caused by a defect in SMN1 ("survival motor neuron") gene, resulting in low levels of the protein SMN, leading to progressive damage to motor neurons and loss of muscle function.

The SUNFISH trial is testing RG7916 in pediatric and adult Type 2/3 SMA patients. In the trial, there was a dose-dependent increase in SMN2 full length/?7 mRNA ratio of roughly 400% versus baseline, as measured in whole blood, according to the Company.

SUNFISH is one of three ongoing clinical trials of RG7916, along with FIREFISH and JEWELFISH. The Company plans to advance RG7916 into pivotal clinical trials in the second half of the year.

Initially developed by PTC Therapeutics in partnership with the SMA Foundation, the worldwide license to RG7800 and RG7916 is now with Roche.

PTCT closed Friday's trading at $18.33, down 0.70%.

SteadyMed Ltd. (STDY) has submitted a New Drug Application to the FDA for its lead drug product candidate, Trevyent, for the treatment of Pulmonary Arterial Hypertension.

Trevyent combines SteadyMed's pre-filled, sterile, single use, disposable, PatchPump infusion system, with treprostinil, a vasodilatory prostacyclin analogue to treat pulmonary arterial hypertension.

The FDA has a 60-day filing review period to determine whether the NDA is complete.

STDY closed Friday's trading at $6.30, unchanged from the previous day's close.

Theratechnologies Inc.'s (TH.TO) Biologics License Application for Ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 has been accepted for priority review, with a decision date set for January 3, 2018.

If approved, Ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing, noted the Company.

Ibalizumab is designated a Breakthrough Therapy and Orphan Drug by the FDA.

TH.TO closed Friday's trading at C$8.58, up 4.38%.