FDA Says No To ATNX And CRMD, Morphic Jumps On IBD Trial Data, INO’s REVEAL 1 Meets Goals

Today’s Daily Dose brings you news about the regulatory set back of Athenex’s oral Paclitaxel and CorMedix’s Defencath, ASLAN Pharma’s Atopic Dermatitis trial results, FDA panel review of FibroGen’s Roxadustat, Morphic Therapeutic’s Phase 1 single ascending dose clinical trial of MORF-057, which is in development for the treatment of inflammatory bowel disease, and STRATA Skin’s CEO transition.

Read on…

1. FDA Sends Athenex Back to Drawing Board

Shares of Athenex Inc. (ATNX) plunged over 54% on Monday to touch a new low, following the FDA’s refusal to approve the company’s oral Paclitaxel plus Encequidar, proposed for the treatment of metastatic breast cancer, due to safety and efficacy concerns.

Paclitaxel is a chemotherapy drug administered intravenously. Athenex’s Oral Paclitaxel is a reformulated version and is co-administered with Encequidar that enables the oral absorption of a wide range of effective anticancer drugs.

While denying approval, the FDA indicated its concerns about safety risks associated with increase in neutropenia-related sequelae in the Oral Paclitaxel arm compared with the IV paclitaxel arm, and concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR).

The company has been asked to conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S.

ATNX closed Monday’s trading at $5.46, down 54.88%.

2. ASLAN Pharma’s Atopic Dermatitis Trial Yields positive Data

ASLAN Pharmaceuticals Limited’s (ASLN) phase I multiple ascending dose study of ASLAN004 in Atopic Dermatitis has yielded positive interim data.

The phase I study evaluated three doses of ASLAN004 (200mg, 400mg and 600mg) delivered subcutaneously and is now recruiting a fourth (expansion) cohort (600mg).

According to the interim results, there was a 74% average reduction in Eczema Area Severity Index (EASI) score from baseline at therapeutic doses (400mg and 600mg) after 8 weeks of treatment compared to 42% for patients on placebo. In the treatment arm, 89% achieved EASI-50 and 67% achieved EASI-75 compared to 0% on the placebo.

EASI-50 is defined as greater than 50% improvement in EASI score and EASI-75 refers to greater than 75% improvement in EASI score.

ASLN closed Monday’s trading at $5.25, up 18.51%. In after-hours, the stock was down 7.76% at $5.00.

3. Avenue Therapeutics To Face FDA In April

Avenue Therapeutics Inc (ATXI) will hear from the FDA whether or not its intravenous (IV) Tramadol is approved on April 12, 2021.

IV Tramadol is proposed for the management of moderate to moderately severe pain in adults in a medically supervised health care setting. This is IV Tramadol’s second go-around with the FDA. Last October, the FDA declined to approve IV Tramadol citing safety concerns.

The New Drug Application for IV Tramadol was resubmitted to the FDA on February 12, 2021, which has been accepted for review and has been assigned a decision date of April 12, 2021.

Tramadol in oral tablet formulation was approved by the FDA way back in 1995. Oral Tramadol is a Schedule IV drug and is widely prescribed in the U.S.

Depending upon a drug’s acceptable medical use and its abuse or dependency potential, it is classified into 5 distinct categories or schedules. Schedule I drugs have high abuse potential and no accepted medical use, while Schedule V drugs have very low abuse/dependency potential.

If approved, intravenous (IV) Tramadol, could be a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S., according to the company.

ATXI closed Monday’s trading at $5.18, up 10.21%.

4. CorMedix Suffers Regulatory Setback

CorMedix Inc.’s (CRMD) Defencath, a synthetic broad-spectrum antimicrobial and antifungal, proposed as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections, has been turned down by the FDA.

Although the FDA has not specified the issues, it has raised concerns regarding the third-party manufacturing facility. The regulatory agency is also requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials.

The company added that the FDA did not request additional clinical data, and did not identify any deficiencies related to the data submitted on the efficacy or safety of Defencath.

Defencath is available in Europe and other territories under the brand name Neutrolin.

Khoso Baluch, CEO, stated that “CorMedix intends to work closely with the FDA and the manufacturing facility to support the completion of the review of the NDA”.

CRMD closed Monday’s trading at $9.02, down 39.87%.

5. FDA Decision on FibroGen’s Roxadustat to Be Delayed Yet Again

Shares of FibroGen Inc. (FGEN) plunged more than 20% in after-hours trading Monday, following yet another delay in the FDA announcing its decision on the new drug application for Roxadustat.

Roxadustat is proposed for the treatment of anemia of chronic kidney disease in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients.

The FDA’s decision on Roxadustat was initially slated for December 20, 2020. But with FibroGen submitting additional analyses of existing Roxadustat clinical data last December, the decision date was postponed to March 20, 2021. Now that the regulatory agency’s Cardiovascular and Renal Drugs Advisory Committee has decided to review the new drug application for Roxadustat, the FDA decision is going to be delayed yet again.

Roxadustat is approved in China, Japan, and Chile.

FibroGen and AstraZeneca are collaborating on the development and commercialization of Roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

FGEN closed Monday’s trading at $50.53, up 1.00%. In after-hours, the stock fell 20.84% to $40.00.

6. INOVIO ‘s REVEAL 1 Study Meets All Goals

INOVIO ‘s (INO) pivotal, phase III trial of VGX-3100 to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions using its proprietary CELLECTRA 5PSP device, has met primary and secondary endpoints.

The trial, dubbed REVEAL 1, is one of the two ongoing pivotal trials of VGX-3100.

The primary endpoint of the trial was histopathological regression of high-grade squamous intraepithelial lesions combined with virologic clearance of HPV-16 and/or HPV-18 at week 36, and the percentage of responders was 23.7% in the treatment group, versus 11.3% in the placebo group, thus achieving statistical significance.

All secondary efficacy endpoints namely regression of cervical HSIL to normal tissue combined with HPV-16/18 viral clearance, regression of cervical HSIL alone, regression of cervical HSIL to normal tissue, and HPV-16/18 viral clearance alone were also met.

INO closed Monday’s trading at $11.60, up 4.50%.

7. Morphic Therapeutic Gets a Facelift

Shares of Morphic Therapeutic (MORF) jumped nearly 135% on Monday, following positive interim results from its Phase 1 single ascending dose clinical trial of MORF-057, which is in development for the treatment of inflammatory bowel disease (IBD).

The phase I clinical trial was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MORF-057 in healthy volunteers.

MORF-057 is an oral small molecule inhibitor of the a4ß7 integrin, a clinically validated target for the treatment of IBD. The key pharmacodynamic measurement in the trial was receptor occupancy (RO), which indicated the percentage of a4ß7 bound by MORF-057 12 hours after the dose.

In the study, MORF-057 achieved greater than 95% mean receptor occupancy of a4ß7 integrin at three highest dose levels, say 100mg, 150mg and 400 mg. MORF-057 well tolerated in all dose cohorts.

The phase I program of MORF-057 also includes a multiple ascending doses (MAD) study evaluating three dose cohorts of MORF-057 as well as a concurrent food-effect study.

Morphic expects to present the full data set from the MORF-057 Phase 1 clinical trial at an appropriate medical meeting in mid-2021 after completion of the multiple ascending dose and food effect portions of MORF-057’s clinical program.

In other news, the company has announced a proposed underwritten public offering in which it intends to offer and sell $200.0 million of shares of its common stock. In addition, Morphic intends to grant the underwriters a 30-day option to purchase up to an additional $30.0 million of shares of its common stock.

MORF closed Monday’s trading at $84.85, up 134.65%. In after-hours, the stock was down 8.66% at $77.50.

8. STRATA Skin Gets A New CEO

STRATA Skin Sciences Inc. (SSKN) has appointed Robert Moccia as President and Chief Executive Officer and a member of the board, effective March 1, 2021, in place of Dolev Rafaeli who stepped down on Feb.28.

Most recently, Robert Moccia served as President, CEO and co-Founder of Encore Dermatology Inc. Prior to that he was CEO of Precision Dermatology Inc. Under the leadership of Moccia, the revenue of Precision Dermatology doubled to more than $100 million and was subsequently acquired by Valeant for approximately $500 million.

SSKN closed Monday’s trading at $1.73, down 5.46%. In after-hours, the stock was up 15.03% at $1.99.

9. Stocks That Gained/Lost The most In A Day

GBS Inc. (GBS) closed Monday’s (Mar.1, 2021) trading at $7.91, up 32.27%.

Apollo Endosurgery Inc. (APEN) closed at $6.10, up 30.06%.

Timber Pharmaceuticals Inc. (TMBR) closed at $2.29, up 27.22%.

Ontrak, Inc. (OTRK) closed at $31.62, down 46.35%.

MannKind Corporation (MNKD) closed at $4.01, down 29.77%.

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