CATB Data Pushed Back To Q1, SMMT At Peak, TRIB Pounded, OTIC Hits Right Notes

Pharma 100516

The FDA has approved continued access to Avita Medical Ltd.'s (AVMXY.OB) investigational device ReCell, thus allowing up to 60 new patients to be treated in its pivotal burns trial.

ReCell is an investigational medical device that enables medical professionals to collect cells from a small sample of a patient's own skin to create a suspension that can regenerate wounds caused by burns.

A pivotal trial of ReCell, which is underway, is expected to be completed in early 2017, following which an application for Pre Market Approval will be submitted. The company hopes its ReCell device to be approved before the end of 2017.

AVMXY.OB closed Tuesday's trading at $1.53, up 3.38%.

Catabasis Pharmaceuticals Inc. (CATB) has completed target enrollment of 30 patients in Part B of its phase II trial of Edasalonexent for the potential treatment of Duchenne Muscular Dystrophy.

The company has previously reported positive safety, tolerability, pharmacokinetics and biomarker results from Part A of the trial.

Top-line safety and efficacy results from the phase 2 trial, dubbed MoveDMD, are now anticipated in the first half of Q1 2017 compared to previous estimate of late year 2016.

CATB closed Tuesday's trading at $5.40, down 6.74%. In after-hours, the stock fell another 1.30% to $5.33.

Five Prime Therapeutics Inc. (FPRX) has initiated the phase 1b portion of its phase 1a/1b trial evaluating the immunotherapy combination of Cabiralizumab with Bristol-Myers Squibb's (BMY) approved drug OPDIVO in multiple tumor types.

The phase 1a portion of the trial evaluated the safety, pharmacokinetics and biomarkers of escalating doses of Cabiralizumab as a monotherapy, as well as in combination with the approved OPDIVO.

Cabiralizumab is also in a phase 2 clinical trial in pigmented villonodular synovitis (PVNS) and a phase 1 clinical trial in oncology indications. The drug candidate is being developed under an agreement entered into with Bristol-Myers in October 2015.

FPRX closed Tuesday's trading at $52.48, up 1.02%.

NewLink Genetics Corp.'s (NLNK) subsidiary has been awarded a contract again, this time valued at $24.8 million, by the Biomedical Advanced Research and Development Authority, or BARDA, to support the advanced development of investigational Ebola Zaire vaccine candidate.

The vaccine, known as V920, is tagged as "Breakthrough Therapy" by the FDA and as PRIME (PRIority MEdicine) by the European Medicines Agency. Merck (MRK) holds the exclusive rights to develop and distribute V920 in the United States and Canada.

NewLink previously received $76.8 million in contracts from BARDA for the development of V920.

NLNK closed Tuesday's trading at $14.69, down 1.54%.

Ocular Therapeutix Inc. (OCUL) has begun enrollment in the first of two planned phase III clinical trials with OTX-TP for the treatment of glaucoma and ocular hypertension.

The study is expected to enroll approximately 550 patients with open angle glaucoma or ocular hypertension at 50 clinical sites. Top-line results from this study are expected to be available in the first half of 2018.

The company plans to commence the second phase 3 clinical trial of OTX-TP in the first half of 2017.

A phase III clinical trial of its most advanced product candidate DEXTENZA for post-surgical ocular inflammation and pain is underway, with topline results expected to be available in the fourth quarter of 2016.

OCUL closed Tuesday's trading at $6.96, up 1.61%.

Otonomy Inc. (OTIC) has successfully completed a phase II clinical trial that evaluated a single administration of OTIPRIO, in two dose levels of 6 mg and 12 mg, for the treatment of pediatric patients with acute otitis media with tympanostomy tubes.

According to the trial results, both OTIPRIO doses were well-tolerated, achieved higher and statistically significant clinical cure rates over sham (no treatment), with the highest clinical cure rate observed in the 12 mg dose group.

OTIPRIO is approved for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery.

OTIC closed Tuesday's trading at $17.55, down 0.45%.

pSivida Corp.'s (PSDV) second phase III trial of Medidur in chronic, non-infectious posterior segment uveitis has met its target enrollment of 150 patients.

The first phase III Medidur trial met the primary efficacy endpoint of prevention of recurrence of posterior segment uveitis at six months in December 2015.

The second phase III study has the same study design and endpoints as the first phase III trial. The primary efficacy endpoint readout in the second study is expected in the second half of 2017.

PSDV closed Tuesday's trading at $2.83, down 3.74%.

It looks like RespireRx Pharmaceuticals Inc. (RSPI.OB) will have to re-analyze the previously reported data from its phase 2A trial of CX1739, as the company has now discovered an error that went noticed until yesterday.

The phase 2A trial evaluated the safety as well as the ability of CX1739 to antagonize the respiratory depressive effect of remifentanil (REMI), a potent opioid, without altering its analgesic properties.

According to the trial results reported last month, CX1739 was proven to be safe and well tolerated, and antagonized the respiratory depressive effects of remifentanil.

Now that an error has been discovered in the data, the company believes that it will effect the efficacy data analysis, although the extent of the effect is not known at this point of time. However, the safety data is expected to remain unchanged.

RSPI.OB closed Tuesday's trading at $4.00, down 5.88%.

Shares of Summit Therapeutics plc (SMMT) rose as much as 128% on Tuesday, following a $562 million license and collaboration agreement, it inked with Sarepta Therapeutics (SRPT).

As per the agreement terms, Sarepta has gained rights in Europe, as well as in Turkey and the Commonwealth of Independent States to Summit's utrophin modulator pipeline, including its lead clinical candidate, Ezutromid, for the treatment of Duchenne muscular dystrophy. Sarepta also has the option for Latin American rights.

Summit's Ezutromid is under a phase II trial, dubbed PhaseOut DMD, and 24-week biopsy data from initial group of patients are expected in Q2/Q3 2017.

The deal entitles Summit to receive an upfront payment of $40 million, with potential future Ezutromid-related milestone payments totaling up to $522 million plus royalties.

As you may know, Sarepta's Exondys 51 was granted accelerated approval by the FDA last month, becoming the first drug to be approved in the U.S. to treat patients with Duchenne muscular dystrophy.

SMMT touched a 52-week high of $19.75 on Tuesday, before closing the day's trading at $14.35, up 65.90%.

Shares of Trinity Biotech plc (TRIB) plunged over 50% on Tuesday, following withdrawal of its 510(k) premarket notification submission for the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer due to concerns associated with clinical performance of the device.

According to the company, the Troponin-I clinical performance is not consistent with the clinical performance data presented by the most recently cleared laboratory Troponin device.

The company said, "Our decision to withdraw is based on the fact that, notwithstanding its excellent performance characteristics, we believe that there is no certainty that this level of performance can be achieved by the Meritas product even with the benefit of further development efforts".

TRIB dropped to a 52-week low of $5.76 on Tuesday, before closing the day's trading at $6.46, down 50.27%.

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