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BLU Plunges On RELIEF Data, FDA Places CLLS' Trial On Hold, IMMU Hits New High, OTIC Music To Ears

pharma 032018 07jul20 lt

Today's Daily Dose brings you news about BLU'S disappointing results from RELIEF trial, FDA hold on CLLS' trial, positive results from Immunomedics' confirmatory trial of Trodelvy, OBSV's phase III studies of Yselty in women with heavy menstrual bleeding due to uterine fibroids, OTIC's tinnitus study results, and clinical progress of REGN's anti-viral cocktail In treatment and prevention of COVID-19.

Read on…

1. No RELIEF For BELLUS Health

Shares of BELLUS Health Inc. (BLU) plunged more than 71 percent on Monday, following disappointing topline results from its phase II trial of BLU-5937 in patients with refractory chronic cough.

In the trial, dubbed RELIEF, the primary endpoint of placebo-adjusted reduction in awake cough frequency did not reach statistical significance. However, highly statistically significant and clinically meaningful reductions in placebo adjusted awake cough frequency were achieved in the pre-specified analysis of high cough count patients (baseline cough frequency at or above the median).

Currently, there are no approved treatments for refractory chronic cough, a condition that affects the quality of life of millions of patients globally.

Based on the RELIEF trial data, BELLUS intends to advance BLU-5937 into an adaptive phase IIb trial enriched for higher cough count patients, and this trial is expected to begin in the fourth quarter of 2020.

BLU closed Monday's trading at $3.40, down 71.7%. In after-hours, the stock gained 9.41% to $3.72.

2. Cellectis' MELANI-01 Trial Placed On Hold Over Safety Concerns

Shares of Cellectis (CLLS) dropped more than 13 percent in extended trading on Monday, following a clinical hold on the Company's phase I open-label First-In-Human dose-escalation clinical study of UCARTCS1A product candidate for the treatment of patients with relapsed or refractory multiple myeloma, dubbed MELANI-01.

The clinical hold was issued by the FDA following a report that one patient enrolled in the MELANI-01 study at dose level two (DL2), with relapsed and refractory multiple myeloma, experienced a fatal treatment-emergent adverse event of cardiac arrest.

Clinical evaluation of the case remains ongoing and additional details as to the immediate and underlying causes of this event are being collected, the Company noted.

CLLS closed Monday's trading at $19.05, up 2.14%. In after-hours, the stock was down 13.39% at $16.50.

3. Immunomedics' Ascent Continues

Shares of Immunomedics Inc. (IMMU) touched an all-time high of $41.40 in intraday trading on Monday, following news that the confirmatory phase III trial of Trodelvy, dubbed ASCENT, met its primary endpoint of progression-free survival (PFS), as well as key secondary endpoints in brain metastasis negative patients with mTNBC who have previously received at least two prior therapies for metastatic disease.

TRODELVY received accelerated FDA approval as recently as April, for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies.

Continued approval depended upon verification of clinical benefit in the ASCENT trial. The Company is planning to file a supplementary Biologics License Application seeking full approval for TRODELVY later this year.

IMMU closed Monday's trading at $40.63, up 8.23%.

4. ObsEva's PRIMROSES Bloom But Fail To Impress Investors

ObsEva SA's (OBSV) two phase III studies of Yselty to assess the efficacy and safety in women with heavy menstrual bleeding due to uterine fibroids, dubbed PRIMROSE 1 and PRIMROSE 2, have yielded positive results.

In the PRIMROSE 1 trial, women receiving Yselty experienced a statistically significant and clinically meaningful reduction in menstrual blood loss compared to placebo at Week 24, which was the primary endpoint. Women receiving 200 mg Yselty with *Add Back Therapy (ABT) achieved a 75.5% responder rate and those receiving 100 mg without ABT achieved a 56.4% responder rate.

The results from the PRIMROSE 2 trial correspond to 52week data. This data demonstrates that continued treatment with Yselty for 52 weeks provides sustained efficacy and is well tolerated. Responder rates of 91.6% and 53.2% were observed in women receiving 200 mg with ABT and 100 mg without ABT, respectively, both of which are similar to the responder rates observed at week 24 of the study. The Company reported positive 24-week data from the PRIMROSE 2 trial last December.

(*Add Back Therapy is 1 mg estradiol and 0.5 mg norethindrone acetate daily).

ObsEva is planning to make regulatory submissions for Yselty to the European Medicines Agency in the fourth quarter and to the FDA in the first half of 2021.

Despite positive results from the two phase III studies, the stock plunged 47.24% on Monday to close the day's trading at $3.24.

5. Otonomy's Message Loud and Clear

Shares of Otonomy Inc. (OTIC) rose more than 18 percent in after-hours on Monday, following positive top-line results from a phase I/II clinical trial of OTO-313 in patients with persistent tinnitus of at least moderate severity.

Tinnitus is the medical term for the perception of noise when there is no sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. Tinnitus is often caused by cochlear injury due to excessive noise, physical trauma, persistent ear infection or exposure to ototoxic agent, leading to over-activation of auditory nerve fibers and the perception of noise in the absence of an external stimulus.

According to the trial results, 43% of OTO-313 patients were responders at both Day 29 and Day 57 compared to 13% of placebo patients. A responder is a patient whose Tinnitus Functional Index (TFI) score decreases by 13-points or more from their baseline score, a change considered clinically meaningful based on the TFI instrument validation.

TFI is a clinically-validated instrument and is rated by the daily reporting of their tinnitus loudness and annoyance.

The Company is expecting two more data readouts in the coming months - results from a phase I/II clinical trial of OTO-413 in patients with hearing loss in the fourth quarter of this year and results from a phase III trial of OTIVIDEX in Ménière's disease in the first quarter of 2021.

OTIC closed Monday's trading at $3.18, up 0.63%. In after-hours, the stock was up 18.56% at $3.77.

6. Regeneron Advances Anti Viral Cocktail In Treatment And Prevention Of COVID-19

Regeneron Pharmaceuticals Inc. (REGN) has initiated a phase III trial to evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate). This trial is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

REGN-COV2 is an anti-viral antibody cocktail being developed for the treatment and prevention of COVID-19.

The Company is also advancing REGN-COV2 into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials to test the cocktail's ability to treat hospitalized and non-hospitalized patients with COVID-19. Preliminary data from this trial are expected later this summer.

REGN closed Monday's trading at $627.25, up 0.77%.

7. Unum Soars On Private Placement

Unum Therapeutics Inc. (UMRX) has completed the acquisition of Kiq LLC, a privately held biotechnology company focused on the discovery and development of precision kinase inhibitors. The acquisition brings PLX9486, which is under a phase I/II trial in patients with Gastrointestinal Stromal Tumors, to Unum's pipeline.

Concurrent with the acquisition, Unum has also entered into a definitive agreement for the sale of Series A non-voting convertible Preferred Stock in a private placement to a group of institutional accredited investors. The private placement is expected to result in gross proceeds to Unum of approximately $104.4 million.

UMRX closed Monday's trading at $2.20, up 394.60%.

8. Stocks That Moved On No News

cbdMD Inc. (YCBD) closed Monday's trading at $2.41, up 23.59%.

BiondVax Pharmaceuticals Ltd. (BVXV) closed Monday's trading at $27.98, up 13.83%.

Monopar Therapeutics Inc. (MNPR) closed Monday's trading at $8.15, up 9.54%.

Liminal BioSciences Inc. (LMNL) closed Monday's trading at $13.69, down 18.27%.

OptiNose Inc. (OPTN) closed Monday's trading at $5.53, down 14.26%.

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