Today’s Daily Dose brings you news about AVEO’s NDA submission for Tivozanib in renal cell carcinoma; EyeGate’s encouraging data in pilot study of dry eye; Kiniksa’s progress in COVID-19 program; delay in the timeline of ProQR Therapeutics’ clinical trial read-outs, near-term catalysts of Trevi; and the launch of VIVUS telemedicine portal.
AVEO Oncology (AVEO) has submitted a New Drug Application to the FDA for Tivozanib, a potential treatment for relapsed or refractory renal cell carcinoma.
The NDA submission is based on the pivotal active comparator-controlled phase III study, dubbed TIVO-3, comparing Tivozanib to Bayer/Onyx’s marketed drug Nexavar in 3rd and 4th line refractory renal cell carcinoma patients.
A final overall survival analysis of the TIVO-3 study will be conducted in the second quarter based on a May 1, 2020 data cutoff date. AVEO expects to report results from the final overall analysis by June 2020.
The FDA and the Company agreed that if, during the review, the final analysis yields an overall analysis hazard ratio above 1.00, the NDA will be withdrawn by the Company.
AVEO closed Tuesday’s trading at $3.62, up 1.40%. In after-hours, the stock was up 11.05% at $4.01.
EyeGate Pharmaceuticals Inc.’s (EYEG) follow-on pilot study of Ocular Bandage Gel eye drops in patients with dry eye has yielded positive results.
In the study that enrolled 20 patients, or 40 eyes, at three sites in the United States, OBG eye drops showed an improvement in central corneal region staining, high order ocular aberrations (“HOA”) and best-corrected visual acuity (“BCVA”), outperforming the positive control, Allergan’s Refresh Preservative-Free lubricant.
This is consistent with the data from EyeGate’s first pilot study where OBG showed positive results in the staining of the central corneal region against a vehicle control, according to the Company.
Ocular Bandage Gel has recently demonstrated statistical significance in a pivotal study for the acceleration of wound healing in patients that have undergone photorefractive keratectomy surgery.
EYEG closed Tuesday’s trading at $5.20, up 27.76%.
Kiniksa Pharmaceuticals Ltd.’s (KNSA) investigational drug Mavrilimumab has produced early evidence of treatment response in patients with severe COVID-19 pneumonia and hyperinflammation.
In a treatment protocol, conducted in Italy, all 6 patients treated with a single intravenous dose of Mavrilimumab showed an early resolution of fever and improvement in oxygenation within 1-3 days. None of those patients have progressed to require mechanical ventilation. Mavrilimumab has been well-tolerated, the Company noted.
A follow-on controlled study in Italy on the cards. Meanwhile, Kiniksa is engaging with the U.S. FDA regarding the path forward for potential phase II/III clinical development of Mavrilimumab in COVID-19 pneumonia.
KNSA closed Tuesday’s trading at $15.48, up 26.68%.
Phio Pharmaceuticals Corp.’s (PHIO) INTASYL technology has demonstrated its potential as a cancer immunotherapy platform for developing novel compounds in animal studies.
The Company noted that in animal studies, the INTASYL-enabled compounds PH-762 and PH-894 showed a complete and statistically significant inhibition of tumor growth, whereas placebo-treated animals displayed exponential tumor growth.
The INTASYL technology can effectively be used to reduce immunosuppression in the tumor microenvironment (TME), which is one of the key challenges for many other immunotherapy platforms to achieve an adequate therapeutic effect in solid tumors, the Company added.
The most advanced INTASYL therapeutic compound in Phio’s pipeline is PH-762 proposed as a treatment for melanoma.
In other news, the Company announced a $4.0 million registered direct offering, priced at-the-market. The closing of the offering is expected to occur on or about April 2, 2020, subject to the satisfaction of customary closing conditions.
PHIO closed Tuesday’s trading at $1.77, down 19.91%. In after-hours, the stock fell another 4.52% to $1.69.
Shares of ProQR Therapeutics N.V. (PRQR) plunged more than 20 percent on Tuesday after the Company announced that there is going to be a delay in all of its ongoing and scheduled trials, including the pivotal trial of Sepofarsen for Leber congenital amaurosis 10, a rare disorder affecting the retina of the eye.
The Company also announced results of interim analysis based on nine and three month data from the first and second dose cohorts, respectively, of its phase I/II trial of QR-421a in patients with Usher syndrome type 2 (USH2), a rare genetic disorder primarily characterized by combined deafness and blindness.
According to the interim analysis, in the phase I/II trial, dubbed STELLAR, QR-421a showed early and encouraging evidence of activity, with 25% of patients showing a benefit across multiple concordant outcome measures and was well tolerated with no serious adverse events.
PRQR closed Tuesday’s trading at $5.49, down 20.20%.
Trevi Therapeutics Inc. (TRVI) soared over 90 percent on Tuesday on no specific news.
The Company is developing Nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF), and levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease.
Nalbuphine ER is an oral, extended-release formulation of Nalbuphine. Administered as a subcutaneous injection for relief of moderate to severe pain in the hospital setting, Nalbuphine was approved by the FDA in 1979.
Trevi has a couple of catalysts to watch out for in the coming months.
— A phase IIb/III trial of Nalbuphine ER for severe pruritus in patients with prurigo nodularis, dubbed PRISM, is underway, with top-line data expected in the second half of 2020.
— A phase II trial of Nalbuphine ER for chronic cough in patients with idiopathic pulmonary fibrosis is also ongoing, with top-line data expected in the second half of 2020.
As of December 31, 2019, the total cash and cash equivalents of the Company were $57.3 million.
TRVI closed Tuesday’s trading at $3.29, up 92.4%.
Amid the Coronavirus crisis, with more doctors and patients preferring telemedicine, it’s only prudent on the part of VIVUS Inc. (VVUS), which markets the obesity drug Qsymia and pancreatic enzyme product Pancreaze, to have accelerated the launch of the telemedicine and remote monitoring modules of its Health Platform.
Participating physicians will be able to use the VIVUS Health Platform to conduct virtual office visits, regardless of whether or not the patient is prescribed a VIVUS product. The Company expects to enroll 150-200 physicians into the new modules each week.
There are no upfront or monthly fees, and physicians pay a fee only for each telemedicine visit and/or for remote patient monitoring. The VIVUS Health Platform is also not limited by a patient’s health insurance plan, the Company noted.
VVUS closed Tuesday’s trading at $3.60, up 278.87%. In after-hours, the stock was down 7.50% at $3.33.
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